- TXT
-
PDF
(PDF provides a complete and accurate display of this text.)
Tip
?
116th Congress } { Report
HOUSE OF REPRESENTATIVES
1st Session } { 116-46
======================================================================
BRINGING LOW-COST OPTIONS AND COMPETITION WHILE KEEPING INCENTIVES FOR
NEW GENERICS ACT OF 2019
_______
May 2, 2019.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Pallone, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 938]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 938) to amend the Federal Food, Drug, and
Cosmetic Act, with respect to eligibility for approval of a
subsequent generic drug, to remove the barrier to that approval
posed by the 180-day exclusivity period afforded to a first
generic applicant that has not yet received final approval, and
for other purposes, having considered the same, report
favorably thereon without amendment and recommend that the bill
do pass.
CONTENTS
Page
I. Purpose and Summary.............................................2
II. Background and Need for the Legislation.........................2
III. Committee Hearings..............................................2
IV. Committee Consideration.........................................3
V. Committee Votes.................................................3
VI. Oversight Findings..............................................3
VII. New Budget Authority, Entitlement Authority, and Tax Expenditure4
VIII. Congressional Budget Office Estimate............................4
IX. Federal Mandates Statement......................................6
X. Statement of General Performance Goals and Objectives...........6
XI. Duplication of Federal Programs.................................6
XII. Committee Cost Estimate.........................................6
XIII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits.....6
XIV. Advisory Committee Statement....................................6
XV. Applicability to Legislative Branch.............................6
XVI. Section-by-Section Analysis of the Legislation..................6
XVII. Changes in Existing Law Made by the Bill, as Reported...........7
Purpose and Summary
H.R. 938, the ``Bringing Low-cost Options and Competition
while Keeping Incentives for New Generics Act of 2019'' or
``BLOCKING Act of 2019'', was introduced on January 31, 2019,
by Rep. Schrader (D-OR) and referred to the Committee on Energy
and Commerce. H.R. 938 will discourage parking of 180-day
exclusivity by a first generic applicant by allowing the Food
and Drug Administration (FDA) to approve a subsequent generic
application prior to the first applicant's first date of
commercial marketing 180 days after the following four
conditions are met: (1) the subsequent application is ready for
full approval; (2) a minimum of 30 months has passed since at
least one first applicant submitted their application for the
drug; (3) any related patent litigation has been fully resolved
by at least one first applicant; and (4) no first applicant has
received final approval.
Background and Need for Legislation
Generic drugs, which typically carry a retail price that is
75 to 90 percent lower than their brand name competitors, can
provide significant cost savings to consumers and the U.S.
healthcare system.\1\
---------------------------------------------------------------------------
\1\U.S. Government Accountability Office, GAO-16-706, Generic Drugs
under Medicare 1 (2016).
---------------------------------------------------------------------------
Under current law, qualified first applicants for generic
drugs are awarded 180 days of exclusivity, which begins to run
when the drug is first marketed. The purpose of this
exclusivity is to provide an incentive for generic products to
enter the market to compete with branded drugs. However, some
first applicants delay seeking final approval after beginning
the application process, which stops the exclusivity from
running while simultaneously blocking any subsequent generic
competition from coming to market. According to FDA, this
occurs an average of five times each year, and each time delays
competition an average of twelve months.\2\ The agency
estimates that this costs patients and the health system an
average of $363 million per year on each drug that gets
delayed.\3\
---------------------------------------------------------------------------
\2\Food and Drug Admin., Measuring the Cost of Delayed ANDA
Approvals (2019) (Included in record for Lowering the Cost of
Prescription Drugs: Reducing Barriers to Market Competition:
Legislative Hearing Before the Subcommittee on Health, 116th Cong.
(2019)).
\3\Id. at 1.
---------------------------------------------------------------------------
The 180-day exclusivity incentive for first generic
applicants was designed to facilitate competition in the
market. H.R. 938 preserves a first applicant's market-based
incentives, as well as the applicant's ability to have their
drug application reviewed, fix deficiencies in facilities and
application, complete patent challenges, and seek final
approval from FDA. This legislation further ensures that
incentives are aligned to bring a drug to market in a timely
fashion, bringing competition and lower costs to patients and
the health system.
Committee Hearings
For the purposes of section 103(i) of H. Res. 6 of the
116th Congress, the following hearing was used to develop or
consider H.R. 938:
The Subcommittee on Health held a legislative hearing on
March 13, 2019, entitled, ``Lowering the Cost of Prescription
Drugs: Reducing Barriers to Market Competition'' to consider
H.R. 938, the ``Bringing Low-cost Options and Competition while
Keeping Incentives for New Generics Act'' and six other bills.
The Subcommittee received testimony from the following
witnesses:
Lou Kennedy, Chief Executive Officer and
Owner, Nephron Pharmaceuticals;
Anthony Barrueta, Senior Vice President for
Government Relations, Kaiser Permanente;
Michael Carrier, Distinguished Professor,
Rutgers Law School;
Kurt Karst, Director, Hyman, Phelps &
McNamara, P.C.;
Jeff Kushan, Partner, Sidley Austin LLP;
Marc M. Boutin, JD, Chief Executive Officer,
National Health Council; and
Chester ``Chip'' Davis, Jr., President and
Chief Executive Officer, Association for Accessible
Medicines.
Committee Consideration
H.R. 938, the ``Bringing Low-cost Options and Competition
while Keeping Incentives for New Generics Act of 2019'' or the
``BLOCKING Act of 2019'', was introduced on February 1, 2019,
by Reps. Schrader (D-OR) and Carter (R-GA) and referred to the
Committee on Energy and Commerce. The bill was subsequently
referred to the Subcommittee on Health on February 2, 2019.
Following a legislative hearing on March 13, 2019, the
Subcommittee met, pursuant to notice, on March 27, 2019, in
open markup session for consideration of H.R. 938.
Subsequently, the Subcommittee on Health agreed to a motion by
Ms. Eshoo, Chairwoman of the Subcommittee, to favorably forward
H.R. 938 to the full Committee, without amendment, by a voice
vote.
On April 3, 2019, the Committee on Energy and Commerce met,
pursuant to notice, in open markup session to consider H.R.
938. No amendments were offered and upon conclusion of
consideration of the bill, the Committee agreed to a motion by
Mr. Pallone, Chairman of the Committee, to order H.R. 938
favorably reported to the House, as introduced, by a voice
vote.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. The
Committee advises that there were no record votes taken on H.R.
938, nor were any amendments offered to the bill. A motion by
Mr. Pallone ordering H.R. 938 favorably reported to the House,
as introduced, was agreed to by a voice vote.
Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1)
of rule X of the Rules of the House of Representatives, the
oversight findings and recommendations of the Committee are
reflected in the descriptive portion of the report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to 3(c)(2) of rule XIII of the Rules of the House
of Representatives, the Committee adopts as its own the
estimate of new budget authority, entitlement authority, or tax
expenditures or revenues contained in the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
Congressional Budget Office Estimate
With respect to the requirements of clause (3)(c)(3) of
rule XIII of the Rules of the House of Representatives and
section 402 of the Congressional Budget Act of 1974, the
Committee has received the following cost estimate for H.R. 938
from the Director of the Congressional Budget Office:
U.S. Congress,
Congressional Budget Office,
Washington, DC, April 26, 2019.
Hon. Frank Pallone, Jr.,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 938, the Bringing
Low-cost Options and Competition while Keeping Incentives for
New Generics Act of 2019.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Ellen
Werble and Julia Christensen.
Sincerely,
Keith Hall,
Director.
Enclosure.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Under current law, manufacturers of generic drugs may seek
approval from the Food and Drug Administration (FDA) to market
a generic drug before the expiration of a patent listed with
the FDA for the brand-name product. The first generic applicant
that submits a substantially complete application to the FDA
challenging an innovator's patent claim may be awarded 180 days
of generic market exclusivity. (The FDA cannot approve any
other generic versions of the drug during that 180-day period.)
If certain conditions are met, the exclusivity period begins
upon the first applicant's commercial marketing.
H.R. 938 would allow the FDA to approve a subsequent
generic drug application that is ready for full approval if no
first applicant has received final approval and other
conditions are satisfied. In such cases, the exclusivity period
would be triggered and would run for 180 days after which time
the subsequent applicant could enter the market.
CBO expects that the bill's provisions would allow generic
drugs to enter the market earlier, on average, than they would
under current law. Because of the earlier entry of lower-priced
generic drugs, CBO estimates, enacting the legislation would
reduce federal spending on prescription drugs and subsidies for
health insurance. In total, CBO estimates that enacting H.R.
938 would decrease the deficit by $442 million over the 2019-
2029 period. That amount includes a $374 million reduction in
direct spending and a $68 million increase in revenues.
CBO also estimates that implementing H.R. 938 would
decrease spending subject to appropriation by $17 million over
the 2019-2024 period, assuming appropriation actions consistent
with the bill. That decrease would occur primarily because
lower estimated drug prices would reduce costs for
discretionary health programs.
Details of the estimated budgetary effect of H.R. 938 are
shown in Table 1. The effects of the legislation fall primarily
within budget functions 550 (health) and 570 (Medicare).
TABLE 1.--ESTIMATED BUDGETARY EFFECTS OF H.R. 938
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, millions of dollars--
-----------------------------------------------------------------------------------------------------------
2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2019-2024 2019-2029
--------------------------------------------------------------------------------------------------------------------------------------------------------
Decreases in Direct Spending
Estimated Outlaysa.......................... 0 0 -12 -34 -38 -39 -44 -47 -49 -57 -53 -124 -374
On-Budget............................... 0 0 -12 -34 -38 -39 -44 -47 -49 -56 -53 -124 -373
Off-Budgetb............................. 0 0 * * * * * * * * * -1 -2
Increases in Revenues
Estimated Revenues.......................... 0 0 3 6 7 7 8 8 9 9 11 23 68
On-Budget............................... 0 0 2 4 5 5 6 6 7 7 8 16 50
Off-Budget.............................. 0 0 1 2 2 2 2 2 2 2 3 7 18
Net Decrease in the Deficit
From Changes in Direct Spending and Revenues
Effect on the Deficit....................... 0 0 -15 -40 -46 -46 -52 -55 -58 -66 -64 -147 -442
On-budget............................... 0 0 -14 -38 -43 -44 -50 -53 -56 -63 -61 -140 -423
Off-budget.............................. 0 0 -1 -2 -2 -2 -2 -2 -2 -2 -3 -8 -20
Decreases in Spending Subject to Appropriation
Estimated Authorization..................... 0 0 -2 -5 -5 -5 n.e. n.e. n.e. n.e. n.e. -17 n.e.
Estimated Outlays........................... 0 0 -2 -5 -5 -5 n.e. n.e. n.e. n.e. n.e. -17 n.e.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Components may not sum to totals because of rounding; n.e. = not estimated; * = between -$500,000 and zero.
aBudget Authority equals Outlays.
bIncludes off-budget effects on the operating costs of the U.S. Postal Service.
The CBO staff contacts for this estimate are Ellen Werble
and Julia Christensen. The estimate was reviewed by Leo Lex,
Deputy Assistant Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to amend
the Federal Food, Drug, and Cosmetic Act with regards to the
eligibility for approval of a subsequent generic drug to remove
the barrier to that approval posed by the 180-day exclusivity
period awarded to a first generic applicant that has not yet
received final approval.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 938 is known to be duplicative of another Federal program,
including any program that was included in a report to Congress
pursuant to section 21 of Public Law 111-139 or the most recent
Catalog of Federal Domestic Assistance.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Earmarks, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 938 contains no earmarks, limited tax
benefits, or limited tariff benefits.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the short title may be cited as
the ``Bringing Low-cost Options and Competition while Keeping
Incentives for New Generics Act of 2019'' or the ``BLOCKING Act
of 2019''.
Section 2. Change conditions of first generic exclusivity to spur
access and competition
Section 2 amends the conditions under which the FDA may
approve a subsequent application for a generic drug when a
first application has been filed.
Paragraph (1) requires FDA to fully approve a subsequent
generic drug application the earlier date of 180 days after the
first generic drug applicant's first date of commercial
marketing of the same drug or 180 days after the applicable
date specified in paragraph (2).
Paragraph (2) specifies the applicable date when FDA may
approve a subsequent generic drug applicant if it falls earlier
than 180 days after the first applicant's first date of
commercial marketing of the same drug. All of the following
conditions must be met for the date to qualify: the subsequent
application meets all other requirements for full approval and
the only remaining obstacle to full approval is a first
applicant's eligibility for 180-day exclusivity; a minimum of
30 months has passed since at least one first applicant
submitted an application for the drug; approval of an
application for the drug submitted by at least one first
applicant is not precluded under clause (iii) of Section
505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act; and
at the time when the above conditions have been met, no first
applicant has yet approved.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, and existing law in which no
change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
new drugs
Sec. 505. (a) No person shall introduce or deliver for
introduction into interstate commerce any new drug, unless an
approval of an application filed pursuant to subsection (b) or
(j) is effective with respect to such drug.
(b)(1) Any person may file with the Secretary an application
with respect to any drug subject to the provisions of
subsection (a). Such persons shall submit to the Secretary as a
part of the application (A) full reports of investigations
which have been made to show whether or not such drug is safe
for use and whether such drug is effective in use; (B) a full
list of the articles used as components of such drug; (C) a
full statement of the composition of such drug; (D) a full
description of the methods used in, and the facilities and
controls used for, the manufacture, processing, and packing of
such drug; (E) such samples of such drug and of the articles
used as components thereof as the Secretary may require; (F)
specimens of the labeling proposed to be used for such drug,
and (G) any assessments required under section 505B. The
applicant shall file with the application the patent number and
the expiration date of any patent which claims the drug for
which the applicant submitted the application or which claims a
method of using such drug and with respect to which a claim of
patent infringement could reasonably be asserted if a person
not licensed by the owner engaged in the manufacture use, or
sale of the drug. If a application is filed under this
subsection for a drug and a patent which claims such drug or a
method of using such drug is issued after the filing date but
before approval of the application, the applicant shall amend
the application to include the information required by the
preceding sentence. Upon approval of the application, the
Secretary shall publish information submitted under the two
preceding sentences. The Secretary shall, in consultation with
the Director of the National Institutes of Health and with
representatives of the drug manufacturing industry, review and
develop guidance, as appropriate, on the inclusion of women and
minorities in clinical trials required by clause (A).
(2) An application submitted under paragraph (1) for a drug
for which the investigations described in clause (A) of such
paragraph and relied upon by the applicant for approval of the
application were not conducted by or for the applicant and for
which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were
conducted shall also include--
(A) a certification, in the opinion of the applicant
and to the best of his knowledge, with respect to each
patent which claims the drug for which such
investigations were conducted or which claims a use for
such drug for which the applicant is seeking approval
under this subsection and for which information is
required to be filed under paragraph (1) or subsection
(c)--
(i) that such patent information has not been
filed,
(ii) that such patent has expired,
(iii) of the date on which such patent will
expire, or
(iv) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(B) if with respect to the drug for which
investigations described in paragraph (1)(A) were
conducted information was filed under paragraph (1) or
subsection (c) for a method of use patent which does
not claim a use for which the applicant is seeking
approval under this subsection, a statement that the
method of use patent does not claim such a use.
(3) Notice of opinion that patent is invalid or will not be
infringed.--
(A) Agreement to give notice.--An applicant that
makes a certification described in paragraph (2)(A)(iv)
shall include in the application a statement that the
applicant will give notice as required by this
paragraph.
(B) Timing of notice.--An applicant that makes a
certification described in paragraph (2)(A)(iv) shall
give notice as required under this paragraph--
(i) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(ii) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(C) Recipients of notice.--An applicant required
under this paragraph to give notice shall give notice
to--
(i) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(ii) the holder of the approved application
under this subsection for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(D) Contents of notice.--A notice required under this
paragraph shall--
(i) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(ii) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(4)(A) An applicant may not amend or supplement an
application referred to in paragraph (2) to seek approval of a
drug that is a different drug than the drug identified in the
application as submitted to the Secretary.
(B) With respect to the drug for which such an application is
submitted, nothing in this subsection or subsection (c)(3)
prohibits an applicant from amending or supplementing the
application to seek approval of a different strength.
(5)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1) or under
section 351 of the Public Health Service Act, which shall
relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection or section 351 of the Public Health Service Act
if the sponsor or applicant makes a reasonable written request
for a meeting for the purpose of reaching agreement on the
design and size--
(i)(I) of clinical trials intended to form the
primary basis of an effectiveness claim; or
(II) in the case where human efficacy studies are not
ethical or feasible, of animal and any associated
clinical trials which, in combination, are intended to
form the primary basis of an effectiveness claim; or
(ii) with respect to an application for approval of a
biological product under section 351(k) of the Public
Health Service Act, of any necessary clinical study or
studies.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of the
clinical trials. Minutes of any such meeting shall be prepared
by the Secretary and made available to the sponsor or applicant
upon request.
(C) Any agreement regarding the parameters of the design and
size of clinical trials of a new drug under this paragraph that
is reached between the Secretary and a sponsor or applicant
shall be reduced to writing and made part of the administrative
record by the Secretary. Such agreement shall not be changed
after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance division personnel unless such field or
compliance division personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection or section 351 of the
Public Health Service Act (including all scientific and medical
matters, chemistry, manufacturing, and controls).
(6) An application submitted under this subsection
shall be accompanied by the certification required
under section 402(j)(5)(B) of the Public Health Service
Act. Such certification shall not be considered an
element of such application.
(c)(1) Within one hundred and eighty days after the filing of
an application under subsection (b), or such additional period
as may be agreed upon by the Secretary and the applicant, the
Secretary shall either--
(A) approve the application if he then finds that
none of the grounds for denying approval specified in
subsection (d) applies, or
(B) give the applicant notice of an opportunity for a
hearing before the Secretary under subsection (d) on
the question whether such application is approvable. If
the applicant elects to accept the opportunity for
hearing by written request within thirty days after
such notice, such hearing shall commence not more than
ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree.
Any such hearing shall thereafter be conducted on an
expedited basis and the Secretary's order thereon shall
be issued within ninety days after the date fixed by
the Secretary for filing final briefs.
(2) If the patent information described in subsection (b)
could not be filed with the submission of an application under
subsection (b) because the application was filed before the
patent information was required under subsection (b) or a
patent was issued after the application was approved under such
subsection, the holder of an approved application shall file
with the Secretary, the patent number and the expiration date
of any patent which claims the drug for which the application
was submitted or which claims a method of using such drug and
with respect to which a claim of patent infringement could
reasonably be asserted if a person not licensed by the owner
engaged in the manufacture, use, or sale of the drug. If the
holder of an approved application could not file patent
information under subsection (b) because it was not required at
the time the application was approved, the holder shall file
such information under this subsection not later than thirty
days after the date of the enactment of this sentence, and if
the holder of an approved application could not file patent
information under subsection (b) because no patent had been
issued when an application was filed or approved, the holder
shall file such information under this subsection not later
than thirty days after after the date the patent involved is
issued. Upon the submission of patent information under this
subsection, the Secretary shall publish it.
(3) The approval of an application filed under subsection (b)
which contains a certification required by paragraph (2) of
such subsection shall be made effective on the last applicable
date determined by applying the following to each certification
made under subsection (b)(2)(A):
(A) If the applicant only made a certification
described in clause (i) or (ii) of subsection (b)(2)(A)
or in both such clauses, the approval may be made
effective immediately.
(B) If the applicant made a certification described
in clause (iii) of subsection (b)(2)(A), the approval
may be made effective on the date certified under
clause (iii).
(C) If the applicant made a certification described
in clause (iv) of subsection (b)(2)(A), the approval
shall be made effective immediately unless, before the
expiration of 45 days after the date on which the
notice described in subsection (b)(3) is received, an
action is brought for infringement of the patent that
is the subject of the certification and for which
information was submitted to the Secretary under
paragraph (2) or subsection (b)(1) before the date on
which the application (excluding an amendment or
supplement to the application) was submitted. If such
an action is brought before the expiration of such
days, the approval may be made effective upon the
expiration of the thirty-month period beginning on the
date of the receipt of the notice provided under
subsection (b)(3) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(i) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(I) the date on which the court
enters judgment reflecting the
decision; or
(II) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(ii) if before the expiration of such period
the district court decides that the patent has
been infringed--
(I) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(aa) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(bb) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(II) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(iii) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in clause (i); or
(iv) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in clause (ii).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(D) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
referred to in subsection (b)(2) for a
declaratory judgment with respect to a
patent which is the subject of the
certification referred to in
subparagraph (C) unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant referred to in subsection
(b)(2) for the purpose of determining
whether an action referred to in
subparagraph (C) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under subsection
(b)(2)(A)(iv) and for no other purpose,
and may not disclose information of no
relevance to any issue of patent
infringement to any person other than a
person provided an offer of
confidential access. Further, the
application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or this subsection
on the ground that the patent does not
claim either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(E)(i) If an application (other than an abbreviated
new drug application) submitted under subsection (b)
for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been
approved in any other application under subsection (b),
was approved during the period beginning January 1,
1982, and ending on the date of the enactment of this
subsection, the Secretary may not make the approval of
another application for a drug for which the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and for which the applicant has not obtained
a right of reference or use from the person by or for
whom the investigations were conducted effective before
the expiration of ten years from the date of the
approval of the application previously approved under
subsection (b).
(ii) If an application submitted under subsection (b)
for a drug, no active ingredient (including any ester
or salt of the active ingredient) of which has been
approved in any other application under subsection (b),
is approved after the date of the enactment of this
clause, no application which refers to the drug for
which the subsection (b) application was submitted and
for which the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted may be
submitted under subsection (b) before the expiration of
five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under subsection (b) after
the expiration of four years from the date of the
approval of the subsection (b) application if it
contains a certification of patent invalidity or
noninfringement described in clause (iv) of subsection
(b)(2)(A). The approval of such an application shall be
made effective in accordance with this paragraph except
that, if an action for patent infringement is commenced
during the one-year period beginning forty-eight months
after the date of the approval of the subsection (b)
application, the thirty-month period referred to in
subparagraph (C) shall be extended by such amount of
time (if any) which is required for seven and one-half
years to have elapsed from the date of approval of the
subsection (b) application.
(iii) If an application submitted under subsection
(b) for a drug, which includes an active ingredient
(including any ester or salt of the active ingredient)
that has been approved in another application approved
under subsection (b), is approved after the date of the
enactment of this clause and if such application
contains reports of new clinical investigations (other
than bioavailability studies) essential to the approval
of the application and conducted or sponsored by the
applicant, the Secretary may not make the approval of
an application submitted under subsection (b) for the
conditions of approval of such drug in the approved
subsection (b) application effective before the
expiration of three years from the date of the approval
of the application under subsection (b) if the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the
investigations were conducted.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment
of this clause and the supplement contains reports of
new clinical investigations (other than bioavailabilty
studies) essential to the approval of the supplement
and conducted or sponsored by the person submitting the
supplement, the Secretary may not make the approval of
an application submitted under subsection (b) for a
change approved in the supplement effective before the
expiration of three years from the date of the approval
of the supplement under subsection (b) if the
investigations described in clause (A) of subsection
(b)(1) and relied upon by the applicant for approval of
the application were not conducted by or for the
applicant and if the applicant has not obtained a right
of reference or use from the person by or for whom the
investigations were conducted.
(v) If an application (or supplement to an
application) submitted under subsection (b) for a drug,
which includes an active ingredient (including any
ester or salt of the active ingredient) that has been
approved in another application under subsection (b),
was approved during the period beginning January 1,
1982, and ending on the date of the enactment of this
clause, the Secretary may not make the approval of an
application submitted under this subsection and for
which the investigations described in clause (A) of
subsection (b)(1) and relied upon by the applicant for
approval of the application were not conducted by or
for the applicant and for which the applicant has not
obtained a right of reference or use from the person by
or for whom the investigations were conducted and which
refers to the drug for which the subsection (b)
application was submitted effective before the
expiration of two years from the date of enactment of
this clause.
(4) A drug manufactured in a pilot or other small facility
may be used to demonstrate the safety and effectiveness of the
drug and to obtain approval for the drug prior to manufacture
of the drug in a larger facility, unless the Secretary makes a
determination that a full scale production facility is
necessary to ensure the safety or effectiveness of the drug.
(5)(A) The Secretary may rely upon qualified data summaries
to support the approval of a supplemental application, with
respect to a qualified indication for a drug, submitted under
subsection (b), if such supplemental application complies with
subparagraph (B).
(B) A supplemental application is eligible for review as
described in subparagraph (A) only if--
(i) there is existing data available and acceptable
to the Secretary demonstrating the safety of the drug;
and
(ii) all data used to develop the qualified data
summaries are submitted to the Secretary as part of the
supplemental application.
(C) The Secretary shall post on the Internet website of the
Food and Drug Administration and update annually--
(i) the number of applications reviewed solely under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(ii) the average time for completion of review under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act;
(iii) the average time for review of supplemental
applications where the Secretary did not use review
flexibility under subparagraph (A) or section
351(a)(2)(E) of the Public Health Service Act; and
(iv) the number of applications reviewed under
subparagraph (A) or section 351(a)(2)(E) of the Public
Health Service Act for which the Secretary made use of
full data sets in addition to the qualified data
summary.
(D) In this paragraph--
(i) the term ``qualified indication'' means an
indication for a drug that the Secretary determines to
be appropriate for summary level review under this
paragraph; and
(ii) the term ``qualified data summary'' means a
summary of clinical data that demonstrates the safety
and effectiveness of a drug with respect to a qualified
indication.
(d) If the Secretary finds, after due notice to the applicant
in accordance with subsection (c) and giving him an opportunity
for a hearing, in accordance with said subsection, that (1) the
investigations, reports of which are required to be submitted
to the Secretary pursuant to subsection (b), do not include
adequate tests by all methods reasonably applicable to show
whether or not such drug is safe for use under the conditions
prescribed, recommended, or suggested in the proposed labeling
thereof; (2) the results of such tests show that such drug is
unsafe for use under such conditions or do not show that such
drug is safe for use under such conditions; (3) the methods
used in, and the facilities and controls used for, the
manufacture, processing, and packing of such drug are
inadequate to preserve its identity, strength, quality, and
purity; (4) upon the basis of the information submitted to him
as part of the application, or upon the basis of any other
information before him with respect to such drug, he has
insufficient information to determine whether such drug is safe
for use under such conditions; or (5) evaluated on the basis of
the information submitted to him as part of the application and
any other information before him with respect to such drug,
there is a lack of substantial evidence that the drug will have
the effect it purports or is represented to have under the
conditions of use prescribed, recommended, or suggested in the
proposed labeling thereof; or (6) the application failed to
contain the patent information prescribed by subsection (b); or
(7) based on a fair evaluation of all material facts, such
labeling is false or misleading in any particular; he shall
issue an order refusing to approve the application. If, after
such notice and opportunity for hearing, the Secretary finds
that clauses (1) through (6) do not apply, he shall issue an
order approving the application. As used in this subsection and
subsection (e), the term ``substantial evidence'' means
evidence consisting of adequate and well-controlled
investigations, including clinical investigations, by experts
qualified by scientific training and experience to evaluate the
effectiveness of the drug involved, on the basis of which it
could fairly and responsibly be concluded by such experts that
the drug will have the effect it purports or is represented to
have under the conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling thereof. If the
Secretary determines, based on relevant science, that data from
one adequate and well-controlled clinical investigation and
confirmatory evidence (obtained prior to or after such
investigation) are sufficient to establish effectiveness, the
Secretary may consider such data and evidence to constitute
substantial evidence for purposes of the preceding sentence.
The Secretary shall implement a structured risk-benefit
assessment framework in the new drug approval process to
facilitate the balanced consideration of benefits and risks, a
consistent and systematic approach to the discussion and
regulatory decisionmaking, and the communication of the
benefits and risks of new drugs. Nothing in the preceding
sentence shall alter the criteria for evaluating an application
for marketing approval of a drug.
(e) The Secretary shall, after due notice and opportunity for
hearing to the applicant, withdraw approval of an application
with respect to any drug under this section if the Secretary
finds (1) that clinical or other experience, tests, or other
scientific data show that such drug is unsafe for use under the
conditions of use upon the basis of which the application was
approved; (2) that new evidence of clinical experience, not
contained in such application or not available to the Secretary
until after such application was approved, or tests by new
methods, or tests by methods not deemed reasonably applicable
when such application was approved, evaluated together with the
evidence available to the Secretary when the application was
approved, shows that such drug is not shown to be safe for use
under the conditions of use upon the basis of which the
application was approved; or (3) on the basis of new
information before him with respect to such drug, evaluated
together with the evidence available to him when the
application was approved, that there is a lack of substantial
evidence that the drug will have the effect it purports or is
represented to have under the conditions of use prescribed,
recommended, or suggested in the labeling thereof; or (4) the
patent information prescribed by subsection (c) was not filed
within thirty days after the receipt of written notice from the
Secretary specifying the failure to file such information; or
(5) that the application contains any untrue statement of a
material fact: Provided, That if the Secretary (or in his
absence the officer acting as Secretary) finds that there is an
imminent hazard to the public health, he may suspend the
approval of such application immediately, and give the
applicant prompt notice of his action and afford the applicant
the opportunity for an expedited hearing under this subsection;
but the authority conferred by this proviso to suspend the
approval of an application shall not be delegated. The
Secretary may also, after due notice and opportunity for
hearing to the applicant, withdraw the approval of an
application submitted under subsection (b) or (j) with respect
to any drug under this section if the Secretary finds (1) that
the applicant has failed to establish a system for maintaining
required records, or has repeatedly or deliberately failed to
maintain such records or to make required reports, in
accordance with a regulation or order under subsection (k) or
to comply with the notice requirements of section 510(k)(2), or
the applicant has refused to permit access to, or copying or
verification of, such records as required by paragraph (2) of
such subsection; or (2) that on the basis of new information
before him, evaluated together with the evidence before him
when the application was approved, the methods used in, or the
facilities and controls used for, the manufacture, processing,
and packing of such drug are inadequate to assure and preserve
its identity, strength, quality, and purity and were not made
adequate within a reasonable time after receipt of written
notice from the Secretary specifying the matter complained of;
or (3) that on the basis of new information before him,
evaluated together with the evidence before him when the
application was approved, the labeling of such drug, based on a
fair evaluation of all material facts, is false or misleading
in any particular and was not corrected within a reasonable
time after receipt of written notice from the Secretary
specifying the matter complained of. Any order under this
subsection shall state the findings upon which it is based. The
Secretary may withdraw the approval of an application submitted
under this section, or suspend the approval of such an
application, as provided under this subsection, without first
ordering the applicant to submit an assessment of the approved
risk evaluation and mitigation strategy for the drug under
section 505-1(g)(2)(D).
(f) Whenever the Secretary finds that the facts so require,
he shall revoke any previous order under subsection (d) or (e)
refusing, withdrawing, or suspending approval of an application
and shall approve such application or reinstate such approval,
as may be appropriate.
(g) Orders of the Secretary issued under this section shall
be served (1) in person by any officer or employee of the
Department designated by the Secretary or (2) by mailing the
order by registered mail or by certified mail addressed to the
applicant or respondent at his last-known address in the
records of the Secretary.
(h) An appeal may be taken by the applicant from an order of
the Secretary refusing or withdrawing approval of an
application under this section. Such appeal shall be taken by
filing in the United States court of appeals for the circuit
wherein such applicant resides or has his principal place of
business, or in the United States Court of Appeals for the
District of Columbia Circuit, within sixty days after the entry
of such order, a written petition praying that the order of the
Secretary be set aside. A copy of such petition shall be
forthwith transmitted by the clerk of the court to the
Secretary, or any officer designated by him for that purpose,
and thereupon the Secretary shall certify and file in the court
the record upon which the order complained of was entered, as
provided in section 2112 of title 28, United States Code. Upon
the filing of such petition such court shall have exclusive
jurisdiction to affirm or set aside such order, except that
until the filing of the record the Secretary may modify or set
aside his order. No objection to the order of the Secretary
shall be considered by the court unless such objection shall
have been urged before the Secretary or unless there were
reasonable grounds for failure so to do. The finding of the
Secretary as to the facts, if supported by substantial
evidence, shall be conclusive. If any person shall apply to the
court for leave to adduce additional evidence, and shall show
to the satisfaction of the court that such additional evidence
is material and that there were reasonable grounds for failure
to adduce such evidence in the proceeding before the Secretary,
the court may order such additional evidence to be taken before
the Secretary and to be adduced upon the hearing in such manner
and upon such terms and conditions as to the court may seem
proper. The Secretary may modify his findings as to the facts
by reason of the additional evidence so taken, and he shall
file with the court such modified findings which, if supported
by substantial evidence, shall be conclusive, and his
recommendation, if any, for the setting aside of the original
order. The judgment of the court affirming or setting aside any
such order of the Secretary shall be final, subject to review
by the Supreme Court of the United States upon certiorari or
certification as provided in section 1254 of title 28 of the
United States Code. The commencement of proceedings under this
subsection shall not, unless specifically ordered by the court
to the contrary, operate as a stay of the Secretary's order.
(i)(1) The Secretary shall promulgate regulations for
exempting from the operation of the foregoing subsections of
this section drugs intended solely for investigational use by
experts qualified by scientific training and experience to
investigate the safety and effectiveness of drugs. Such
regulations may, within the discretion of the Secretary, among
other conditions relating to the protection of the public
health, provide for conditioning such exemption upon--
(A) the submission to the Secretary, before any
clinical testing of a new drug is undertaken, of
reports, by the manufacturer or the sponsor of the
investigation of such drug, or preclinical tests
(including tests on animals) of such drug adequate to
justify the proposed clinical testing;
(B) the manufacturer or the sponsor of the
investigation of a new drug proposed to be distributed
to investigators for clinical testing obtaining a
signed agreement from each of such investigators that
patients to whom the drug is administered will be under
his personal supervision, or under the supervision of
investigators responsible to him, and that he will not
supply such drug to any other investigator, or to
clinics, for administration to human beings;
(C) the establishment and maintenance of such
records, and the making of such reports to the
Secretary, by the manufacturer or the sponsor of the
investigation of such drug, of data (including but not
limited to analytical reports by investigators)
obtained as the result of such investigational use of
such drug, as the Secretary finds will enable him to
evaluate the safety and effectiveness of such drug in
the event of the filing of an application pursuant to
subsection (b); and
(D) the submission to the Secretary by the
manufacturer or the sponsor of the
investigation of a new drug of a statement of
intent regarding whether the manufacturer or
sponsor has plans for assessing pediatric
safety and efficacy.
(2) Subject to paragraph (3), a clinical investigation of a
new drug may begin 30 days after the Secretary has received
from the manufacturer or sponsor of the investigation a
submission containing such information about the drug and the
clinical investigation, including--
(A) information on design of the investigation and
adequate reports of basic information, certified by the
applicant to be accurate reports, necessary to assess
the safety of the drug for use in clinical
investigation; and
(B) adequate information on the chemistry and
manufacturing of the drug, controls available for the
drug, and primary data tabulations from animal or human
studies.
(3)(A) At any time, the Secretary may prohibit the sponsor of
an investigation from conducting the investigation (referred to
in this paragraph as a ``clinical hold'') if the Secretary
makes a determination described in subparagraph (B). The
Secretary shall specify the basis for the clinical hold,
including the specific information available to the Secretary
which served as the basis for such clinical hold, and confirm
such determination in writing.
(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical hold
is that--
(i) the drug involved represents an unreasonable risk
to the safety of the persons who are the subjects of
the clinical investigation, taking into account the
qualifications of the clinical investigators,
information about the drug, the design of the clinical
investigation, the condition for which the drug is to
be investigated, and the health status of the subjects
involved; or
(ii) the clinical hold should be issued for such
other reasons as the Secretary may by regulation
establish (including reasons established by regulation
before the date of the enactment of the Food and Drug
Administration Modernization Act of 1997).
(C) Any written request to the Secretary from the sponsor of
an investigation that a clinical hold be removed shall receive
a decision, in writing and specifying the reasons therefor,
within 30 days after receipt of such request. Any such request
shall include sufficient information to support the removal of
such clinical hold.
(4) Regulations under paragraph (1) shall provide that such
exemption shall be conditioned upon the manufacturer, or the
sponsor of the investigation, requiring that experts using such
drugs for investigational purposes certify to such manufacturer
or sponsor that they will inform any human beings to whom such
drugs, or any controls used in connection therewith, are being
administered, or their representatives, that such drugs are
being used for investigational purposes and will obtain the
consent of such human beings or their representatives, except
where it is not feasible, it is contrary to the best interests
of such human beings, or the proposed clinical testing poses no
more than minimal risk to such human beings and includes
appropriate safeguards as prescribed to protect the rights,
safety, and welfare of such human beings. Nothing in this
subsection shall be construed to require any clinical
investigator to submit directly to the Secretary reports on the
investigational use of drugs. The Secretary shall update such
regulations to require inclusion in the informed consent
documents and process a statement that clinical trial
information for such clinical investigation has been or will be
submitted for inclusion in the registry data bank pursuant to
subsection (j) of section 402 of the Public Health Service Act.
(j)(1) Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
(2)(A) An abbreviated application for a new drug shall
contain--
(i) information to show that the conditions of use
prescribed, recommended, or suggested in the labeling
proposed for the new drug have been previously approved
for a drug listed under paragraph (7) (hereinafter in
this subsection referred to as a ``listed drug'');
(ii)(I) if the listed drug referred to in clause (i)
has only one active ingredient, information to show
that the active ingredient of the new drug is the same
as that of the listed drug;
(II) if the listed drug referred to in clause (i) has
more than one active ingredient, information to show
that the active ingredients of the new drug are the
same as those of the listed drug, or
(III) if the listed drug referred to in clause (i)
has more than one active ingredient and if one of the
active ingredients of the new drug is different and the
application is filed pursuant to the approval of a
petition filed under subparagraph (C), information to
show that the other active ingredients of the new drug
are the same as the active ingredients of the listed
drug, information to show that the different active
ingredient is an active ingredient of a listed drug or
of a drug which does not meet the requirements of
section 201(p), and such other information respecting
the different active ingredient with respect to which
the petition was filed as the Secretary may require;
(iii) information to show that the route of
administration, the dosage form, and the strength of
the new drug are the same as those of the listed drug
referred to in clause (i) or, if the route of
administration, the dosage form, or the strength of the
new drug is different and the application is filed
pursuant to the approval of a petition filed under
subparagraph (C), such information respecting the route
of administration, dosage form, or strength with
respect to which the petition was filed as the
Secretary may require;
(iv) information to show that the new drug is
bioequivalent to the listed drug referred to in clause
(i), except that if the application is filed pursuant
to the approval of a petition filed under subparagraph
(C), information to show that the active ingredients of
the new drug are of the same pharmacological or
therapeutic class as those of the listed drug referred
to in clause (i) and the new drug can be expected to
have the same therapeutic effect as the listed drug
when administered to patients for a condition of use
referred to in clause (i);
(v) information to show that the labeling proposed
for the new drug is the same as the labeling approved
for the listed drug referred to in clause (i) except
for changes required because of differences approved
under a petition filed under subparagraph (C) or
because the new drug and the listed drug are produced
or distributed by different manufacturers;
(vi) the items specified in clauses (B) through (F)
of subsection (b)(1);
(vii) a certification, in the opinion of the
applicant and to the best of his knowledge, with
respect to each patent which claims the listed drug
referred to in clause (i) or which claims a use for
such listed drug for which the applicant is seeking
approval under this subsection and for which
information is required to be filed under subsection
(b) or (c)--
(I) that such patent information has not been
filed,
(II) that such patent has expired,
(III) of the date on which such patent will
expire, or
(IV) that such patent is invalid or will not
be infringed by the manufacture, use, or sale
of the new drug for which the application is
submitted; and
(viii) if with respect to the listed drug referred to
in clause (i) information was filed under subsection
(b) or (c) for a method of use patent which does not
claim a use for which the applicant is seeking approval
under this subsection, a statement that the method of
use patent does not claim such a use.
The Secretary may not require that an abbreviated application
contain information in addition to that required by clauses (i)
through (viii).
(B) Notice of opinion that patent is invalid or will not be
infringed.--
(i) Agreement to give notice.--An applicant that
makes a certification described in subparagraph
(A)(vii)(IV) shall include in the application a
statement that the applicant will give notice as
required by this subparagraph.
(ii) Timing of notice.--An applicant that makes a
certification described in subparagraph (A)(vii)(IV)
shall give notice as required under this subparagraph--
(I) if the certification is in the
application, not later than 20 days after the
date of the postmark on the notice with which
the Secretary informs the applicant that the
application has been filed; or
(II) if the certification is in an amendment
or supplement to the application, at the time
at which the applicant submits the amendment or
supplement, regardless of whether the applicant
has already given notice with respect to
another such certification contained in the
application or in an amendment or supplement to
the application.
(iii) Recipients of notice.--An applicant required
under this subparagraph to give notice shall give
notice to--
(I) each owner of the patent that is the
subject of the certification (or a
representative of the owner designated to
receive such a notice); and
(II) the holder of the approved application
under subsection (b) for the drug that is
claimed by the patent or a use of which is
claimed by the patent (or a representative of
the holder designated to receive such a
notice).
(iv) Contents of notice.--A notice required under
this subparagraph shall--
(I) state that an application that contains
data from bioavailability or bioequivalence
studies has been submitted under this
subsection for the drug with respect to which
the certification is made to obtain approval to
engage in the commercial manufacture, use, or
sale of the drug before the expiration of the
patent referred to in the certification; and
(II) include a detailed statement of the
factual and legal basis of the opinion of the
applicant that the patent is invalid or will
not be infringed.
(C) If a person wants to submit an abbreviated application
for a new drug which has a different active ingredient or whose
route of administration, dosage form, or strength differ from
that of a listed drug, such person shall submit a petition to
the Secretary seeking permission to file such an application.
The Secretary shall approve or disapprove a petition submitted
under this subparagraph within ninety days of the date the
petition is submitted. The Secretary shall approve such a
petition unless the Secretary finds--
(i) that investigations must be conducted to show the
safety and effectiveness of the drug or of any of its
active ingredients, the route of administration, the
dosage form, or strength which differ from the listed
drug; or
(ii) that any drug with a different active ingredient
may not be adequately evaluated for approval as safe
and effective on the basis of the information required
to be submitted in an abbreviated application.
(D)(i) An applicant may not amend or supplement an
application to seek approval of a drug referring to a different
listed drug from the listed drug identified in the application
as submitted to the Secretary.
(ii) With respect to the drug for which an application is
submitted, nothing in this subsection prohibits an applicant
from amending or supplementing the application to seek approval
of a different strength.
(iii) Within 60 days after the date of the enactment of the
Medicare Prescription Drug, Improvement, and Modernization Act
of 2003, the Secretary shall issue guidance defining the term
``listed drug'' for purposes of this subparagraph.
(3)(A) The Secretary shall issue guidance for the individuals
who review applications submitted under paragraph (1), which
shall relate to promptness in conducting the review, technical
excellence, lack of bias and conflict of interest, and
knowledge of regulatory and scientific standards, and which
shall apply equally to all individuals who review such
applications.
(B) The Secretary shall meet with a sponsor of an
investigation or an applicant for approval for a drug under
this subsection if the sponsor or applicant makes a reasonable
written request for a meeting for the purpose of reaching
agreement on the design and size of bioavailability and
bioequivalence studies needed for approval of such application.
The sponsor or applicant shall provide information necessary
for discussion and agreement on the design and size of such
studies. Minutes of any such meeting shall be prepared by the
Secretary and made available to the sponsor or applicant.
(C) Any agreement regarding the parameters of design and size
of bioavailability and bioequivalence studies of a drug under
this paragraph that is reached between the Secretary and a
sponsor or applicant shall be reduced to writing and made part
of the administrative record by the Secretary. Such agreement
shall not be changed after the testing begins, except--
(i) with the written agreement of the sponsor or
applicant; or
(ii) pursuant to a decision, made in accordance with
subparagraph (D) by the director of the reviewing
division, that a substantial scientific issue essential
to determining the safety or effectiveness of the drug
has been identified after the testing has begun.
(D) A decision under subparagraph (C)(ii) by the director
shall be in writing and the Secretary shall provide to the
sponsor or applicant an opportunity for a meeting at which the
director and the sponsor or applicant will be present and at
which the director will document the scientific issue involved.
(E) The written decisions of the reviewing division shall be
binding upon, and may not directly or indirectly be changed by,
the field or compliance office personnel unless such field or
compliance office personnel demonstrate to the reviewing
division why such decision should be modified.
(F) No action by the reviewing division may be delayed
because of the unavailability of information from or action by
field personnel unless the reviewing division determines that a
delay is necessary to assure the marketing of a safe and
effective drug.
(G) For purposes of this paragraph, the reviewing division is
the division responsible for the review of an application for
approval of a drug under this subsection (including scientific
matters, chemistry, manufacturing, and controls).
(4) Subject to paragraph (5), the Secretary shall approve an
application for a drug unless the Secretary finds--
(A) the methods used in, or the facilities and
controls used for, the manufacture, processing, and
packing of the drug are inadequate to assure and
preserve its identity, strength, quality, and purity;
(B) information submitted with the application is
insufficient show that each of the proposed conditions
of use have been previously approved for the listed
drug referred to in the application;
(C)(i) if the listed drug has only one active
ingredient, information submitted with the application
is insufficient to show that the active ingredient is
the same as that of the listed drug;
(ii) if the listed drug has more than one active
ingredient, information submitted with the application
is insufficient to show that the active ingredients are
the same as the active ingredients of the listed drug,
or
(iii) if the listed drug has more than one active
ingredient and if the application is for a drug which
has an active ingredient different from the listed
drug, information submitted with the application is
insufficient to show--
(I) that the other active ingredients are the
same as the active ingredients of the listed
drug, or
(II) that the different active ingredient is
an active ingredient of a listed drug or a drug
which does not meet the requirements of section
201(p),
or no petition to file an application for the drug with
the different ingredient was approved under paragraph
(2)(C);
(D)(i) if the application is for a drug whose route
of administration, dosage form, or strength of the drug
is the same as the route of administration, dosage
form, or strength of the listed drug referred to in the
application, information submitted in the application
is insufficient to show that the route of
administration, dosage form, or strength is the same as
that of the listed drug, or
(ii) if the application is for a drug whose route of
administration, dosage form, or strength of the drug is
different from that of the listed drug referred to in
the application, no petition to file an application for
the drug with the different route of administration,
dosage form, or strength was approved under paragraph
(2)(C);
(E) if the application was filed pursuant to the
approval of a petition under paragraph (2)(C), the
application did not contain the information required by
the Secretary respecting the active ingredient, route
of administration, dosage form, or strength which is
not the same;
(F) information submitted in the application is
insufficient to show that the drug is bioequivalent to
the listed drug referred to in the application or, if
the application was filed pursuant to a petition
approved under paragraph (2)(C), information submitted
in the application is insufficient to show that the
active ingredients of the new drug are of the same
pharmacological or therapeutic class as those of the
listed drug referred to in paragraph (2)(A)(i) and that
the new drug can be expected to have the same
therapeutic effect as the listed drug when administered
to patients for a condition of use referred to in such
paragraph;
(G) information submitted in the application is
insufficient to show that the labeling proposed for the
drug is the same as the labeling approved for the
listed drug referred to in the application except for
changes required because of differences approved under
a petition filed under paragraph (2)(C) or because the
drug and the listed drug are produced or distributed by
different manufacturers;
(H) information submitted in the application or any
other information available to the Secretary shows that
(i) the inactive ingredients of the drug are unsafe for
use under the conditions prescribed, recommended, or
suggested in the labeling proposed for the drug, or
(ii) the composition of the drug is unsafe under such
conditions because of the type or quantity of inactive
ingredients included or the manner in which the
inactive ingredients are included;
(I) the approval under subsection (c) of the listed
drug referred to in the application under this
subsection has been withdrawn or suspended for grounds
described in the first sentence of subsection (e), the
Secretary has published a notice of opportunity for
hearing to withdraw approval of the listed drug under
subsection (c) for grounds described in the first
sentence of subsection (e), the approval under this
subsection of the listed drug referred to in the
application under this subsection has been withdrawn or
suspended under paragraph (6), or the Secretary has
determined that the listed drug has been withdrawn from
sale for safety or effectiveness reasons;
(J) the application does not meet any other
requirement of paragraph (2)(A); or
(K) the application contains an untrue statement of
material fact.
(5)(A) Within one hundred and eighty days of the initial
receipt of an application under paragraph (2) or within such
additional period as may be agreed upon by the Secretary and
the applicant, the Secretary shall approve or disapprove the
application.
(B) The approval of an application submitted under paragraph
(2) shall be made effective on the last applicable date
determined by applying the following to each certification made
under paragraph (2)(A)(vii):
(i) If the applicant only made a certification
described in subclause (I) or (II) of paragraph
(2)(A)(vii) or in both such subclauses, the approval
may be made effective immediately.
(ii) If the applicant made a certification described
in subclause (III) of paragraph (2)(A)(vii), the
approval may be made effective on the date certified
under subclause (III).
(iii) If the applicant made a certification described
in subclause (IV) of paragraph (2)(A)(vii), the
approval shall be made effective immediately unless,
before the expiration of 45 days after the date on
which the notice described in paragraph (2)(B) is
received, an action is brought for infringement of the
patent that is the subject of the certification and for
which information was submitted to the Secretary under
subsection (b)(1) or (c)(2) before the date on which
the application (excluding an amendment or supplement
to the application), which the Secretary later
determines to be substantially complete, was submitted.
If such an action is brought before the expiration of
such days, the approval shall be made effective upon
the expiration of the thirty-month period beginning on
the date of the receipt of the notice provided under
paragraph (2)(B)(i) or such shorter or longer period as
the court may order because either party to the action
failed to reasonably cooperate in expediting the
action, except that--
(I) if before the expiration of such period
the district court decides that the patent is
invalid or not infringed (including any
substantive determination that there is no
cause of action for patent infringement or
invalidity), the approval shall be made
effective on--
(aa) the date on which the court
enters judgment reflecting the
decision; or
(bb) the date of a settlement order
or consent decree signed and entered by
the court stating that the patent that
is the subject of the certification is
invalid or not infringed;
(II) if before the expiration of such period
the district court decides that the patent has
been infringed--
(aa) if the judgment of the district
court is appealed, the approval shall
be made effective on--
(AA) the date on which the
court of appeals decides that
the patent is invalid or not
infringed (including any
substantive determination that
there is no cause of action for
patent infringement or
invalidity); or
(BB) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the patent
that is the subject of the
certification is invalid or not
infringed; or
(bb) if the judgment of the district
court is not appealed or is affirmed,
the approval shall be made effective on
the date specified by the district
court in a court order under section
271(e)(4)(A) of title 35, United States
Code;
(III) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent is invalid or not
infringed, the approval shall be made effective
as provided in subclause (I); or
(IV) if before the expiration of such period
the court grants a preliminary injunction
prohibiting the applicant from engaging in the
commercial manufacture or sale of the drug
until the court decides the issues of patent
validity and infringement and if the court
decides that such patent has been infringed,
the approval shall be made effective as
provided in subclause (II).
In such an action, each of the parties shall reasonably
cooperate in expediting the action.
(iv) 180-day exclusivity period.--
(I) Effectiveness of application.--Subject to
subparagraph (D), if the application contains a
certification described in paragraph
(2)(A)(vii)(IV) and is for a drug for which a
first applicant has submitted an application
containing such a certification, the
application shall be made effective on the date
that is [180 days after the date of the first
commercial marketing of the drug (including the
commercial marketing of the listed drug) by any
first applicant.] 180 days after the earlier
of--
(aa) the date of the first
commercial marketing of the
drug (including the commercial
marketing of the listed drug)
by any first applicant; or
(bb) the applicable date
specified in subclause (III).
(II) Definitions.--In this paragraph:
(aa) 180-day exclusivity period.--
The term ``180-day exclusivity period''
means the 180-day period ending on the
day before the date on which an
application submitted by an applicant
other than a first applicant could
become effective under this clause.
(bb) First applicant.--As used in
this subsection, the term ``first
applicant'' means an applicant that, on
the first day on which a substantially
complete application containing a
certification described in paragraph
(2)(A)(vii)(IV) is submitted for
approval of a drug, submits a
substantially complete application that
contains and lawfully maintains a
certification described in paragraph
(2)(A)(vii)(IV) for the drug.
(cc) Substantially complete
application.--As used in this
subsection, the term ``substantially
complete application'' means an
application under this subsection that
on its face is sufficiently complete to
permit a substantive review and
contains all the information required
by paragraph (2)(A).
(dd) Tentative approval.--
(AA) In general.--The term
``tentative approval'' means
notification to an applicant by
the Secretary that an
application under this
subsection meets the
requirements of paragraph
(2)(A), but cannot receive
effective approval because the
application does not meet the
requirements of this
subparagraph, there is a period
of exclusivity for the listed
drug under subparagraph (F) or
section 505A, or there is a 7-
year period of exclusivity for
the listed drug under section
527.
(BB) Limitation.--A drug that
is granted tentative approval
by the Secretary is not an
approved drug and shall not
have an effective approval
until the Secretary issues an
approval after any necessary
additional review of the
application.
(III) Applicable date.--The
applicable date specified in this
subclause, with respect to an
application for a drug described in
subclause (I), is the date on which
each of the following conditions is
first met:
(aa) The approval of such an
application could be made
effective, but for the
eligibility of a first
applicant for 180-day
exclusivity under this clause.
(bb) At least 30 months have
passed since the date of
submission of an application
for the drug by at least one
first applicant.
(cc) Approval of an
application for the drug
submitted by at least one first
applicant is not precluded
under clause (iii).
(dd) No application for the
drug submitted by any first
applicant is approved at the
time the conditions under items
(aa), (bb), and (cc) are all
met, regardless of whether such
an application is subsequently
approved.
(v) 180-day exclusivity period for competitive
generic therapies.--
(I) Effectiveness of application.--Subject to
subparagraph (D)(iv), if the application is for
a drug that is the same as a competitive
generic therapy for which any first approved
applicant has commenced commercial marketing,
the application shall be made effective on the
date that is 180 days after the date of the
first commercial marketing of the competitive
generic therapy (including the commercial
marketing of the listed drug) by any first
approved applicant.
(II) Limitation.--The exclusivity period
under subclause (I) shall not apply with
respect to a competitive generic therapy that
has previously received an exclusivity period
under subclause (I).
(III) Definitions.--In this clause and
subparagraph (D)(iv):
(aa) The term ``competitive generic
therapy'' means a drug--
(AA) that is designated as a
competitive generic therapy
under section 506H; and
(BB) for which there are no
unexpired patents or
exclusivities on the list of
products described in section
505(j)(7)(A) at the time of
submission.
(bb) The term ``first approved
applicant'' means any applicant that
has submitted an application that--
(AA) is for a competitive
generic therapy that is
approved on the first day on
which any application for such
competitive generic therapy is
approved;
(BB) is not eligible for a
180-day exclusivity period
under clause (iv) for the drug
that is the subject of the
application for the competitive
generic therapy; and
(CC) is not for a drug for
which all drug versions have
forfeited eligibility for a
180-day exclusivity period
under clause (iv) pursuant to
subparagraph (D).
(C) Civil action to obtain patent certainty.--
(i) Declaratory judgment absent infringement
action.--
(I) In general.--No action may be
brought under section 2201 of title 28,
United States Code, by an applicant
under paragraph (2) for a declaratory
judgment with respect to a patent which
is the subject of the certification
referred to in subparagraph (B)(iii)
unless--
(aa) the 45-day period
referred to in such
subparagraph has expired;
(bb) neither the owner of
such patent nor the holder of
the approved application under
subsection (b) for the drug
that is claimed by the patent
or a use of which is claimed by
the patent brought a civil
action against the applicant
for infringement of the patent
before the expiration of such
period; and
(cc) in any case in which the
notice provided under paragraph
(2)(B) relates to
noninfringement, the notice was
accompanied by a document
described in subclause (III).
(II) Filing of civil action.--If the
conditions described in items (aa),
(bb), and as applicable, (cc) of
subclause (I) have been met, the
applicant referred to in such subclause
may, in accordance with section 2201 of
title 28, United States Code, bring a
civil action under such section against
the owner or holder referred to in such
subclause (but not against any owner or
holder that has brought such a civil
action against the applicant, unless
that civil action was dismissed without
prejudice) for a declaratory judgment
that the patent is invalid or will not
be infringed by the drug for which the
applicant seeks approval, except that
such civil action may be brought for a
declaratory judgment that the patent
will not be infringed only in a case in
which the condition described in
subclause (I)(cc) is applicable. A
civil action referred to in this
subclause shall be brought in the
judicial district where the defendant
has its principal place of business or
a regular and established place of
business.
(III) Offer of confidential access to
application.--For purposes of subclause
(I)(cc), the document described in this
subclause is a document providing an
offer of confidential access to the
application that is in the custody of
the applicant under paragraph (2) for
the purpose of determining whether an
action referred to in subparagraph
(B)(iii) should be brought. The
document providing the offer of
confidential access shall contain such
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, as would
apply had a protective order been
entered for the purpose of protecting
trade secrets and other confidential
business information. A request for
access to an application under an offer
of confidential access shall be
considered acceptance of the offer of
confidential access with the
restrictions as to persons entitled to
access, and on the use and disposition
of any information accessed, contained
in the offer of confidential access,
and those restrictions and other terms
of the offer of confidential access
shall be considered terms of an
enforceable contract. Any person
provided an offer of confidential
access shall review the application for
the sole and limited purpose of
evaluating possible infringement of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV) and for no other
purpose, and may not disclose
information of no relevance to any
issue of patent infringement to any
person other than a person provided an
offer of confidential access. Further,
the application may be redacted by the
applicant to remove any information of
no relevance to any issue of patent
infringement.
(ii) Counterclaim to infringement action.--
(I) In general.--If an owner of the
patent or the holder of the approved
application under subsection (b) for
the drug that is claimed by the patent
or a use of which is claimed by the
patent brings a patent infringement
action against the applicant, the
applicant may assert a counterclaim
seeking an order requiring the holder
to correct or delete the patent
information submitted by the holder
under subsection (b) or (c) on the
ground that the patent does not claim
either--
(aa) the drug for which the
application was approved; or
(bb) an approved method of
using the drug.
(II) No independent cause of
action.--Subclause (I) does not
authorize the assertion of a claim
described in subclause (I) in any civil
action or proceeding other than a
counterclaim described in subclause
(I).
(iii) No damages.--An applicant shall not be
entitled to damages in a civil action under
clause (i) or a counterclaim under clause (ii).
(D) Forfeiture of 180-day exclusivity period.--
(i) Definition of forfeiture event.--In this
subparagraph, the term ``forfeiture event'',
with respect to an application under this
subsection, means the occurrence of any of the
following:
(I) Failure to market.--The first
applicant fails to market the drug by
the later of--
(aa) the earlier of the date
that is--
(AA) 75 days after
the date on which the
approval of the
application of the
first applicant is made
effective under
subparagraph (B)(iii);
or
(BB) 30 months after
the date of submission
of the application of
the first applicant; or
(bb) with respect to the
first applicant or any other
applicant (which other
applicant has received
tentative approval), the date
that is 75 days after the date
as of which, as to each of the
patents with respect to which
the first applicant submitted
and lawfully maintained a
certification qualifying the
first applicant for the 180-day
exclusivity period under
subparagraph (B)(iv), at least
1 of the following has
occurred:
(AA) In an
infringement action
brought against that
applicant with respect
to the patent or in a
declaratory judgment
action brought by that
applicant with respect
to the patent, a court
enters a final decision
from which no appeal
(other than a petition
to the Supreme Court
for a writ of
certiorari) has been or
can be taken that the
patent is invalid or
not infringed.
(BB) In an
infringement action or
a declaratory judgment
action described in
subitem (AA), a court
signs a settlement
order or consent decree
that enters a final
judgment that includes
a finding that the
patent is invalid or
not infringed.
(CC) The patent
information submitted
under subsection (b) or
(c) is withdrawn by the
holder of the
application approved
under subsection (b).
(II) Withdrawal of application.--The
first applicant withdraws the
application or the Secretary considers
the application to have been withdrawn
as a result of a determination by the
Secretary that the application does not
meet the requirements for approval
under paragraph (4).
(III) Amendment of certification.--
The first applicant amends or withdraws
the certification for all of the
patents with respect to which that
applicant submitted a certification
qualifying the applicant for the 180-
day exclusivity period.
(IV) Failure to obtain tentative
approval.--The first applicant fails to
obtain tentative approval of the
application within 30 months after the
date on which the application is filed,
unless the failure is caused by a
change in or a review of the
requirements for approval of the
application imposed after the date on
which the application is filed.
(V) Agreement with another applicant,
the listed drug application holder, or
a patent owner.--The first applicant
enters into an agreement with another
applicant under this subsection for the
drug, the holder of the application for
the listed drug, or an owner of the
patent that is the subject of the
certification under paragraph
(2)(A)(vii)(IV), the Federal Trade
Commission or the Attorney General
files a complaint, and there is a final
decision of the Federal Trade
Commission or the court with regard to
the complaint from which no appeal
(other than a petition to the Supreme
Court for a writ of certiorari) has
been or can be taken that the agreement
has violated the antitrust laws (as
defined in section 1 of the Clayton Act
(15 U.S.C. 12), except that the term
includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the
extent that that section applies to
unfair methods of competition).
(VI) Expiration of all patents.--All
of the patents as to which the
applicant submitted a certification
qualifying it for the 180-day
exclusivity period have expired.
(ii) Forfeiture.--The 180-day exclusivity
period described in subparagraph (B)(iv) shall
be forfeited by a first applicant if a
forfeiture event occurs with respect to that
first applicant.
(iii) Subsequent applicant.--If all first
applicants forfeit the 180-day exclusivity
period under clause (ii)--
(I) approval of any application
containing a certification described in
paragraph (2)(A)(vii)(IV) shall be made
effective in accordance with
subparagraph (B)(iii); and
(II) no applicant shall be eligible
for a 180-day exclusivity period.
(iv) Special forfeiture rule for competitive
generic therapy.--The 180-day exclusivity
period described in subparagraph (B)(v) shall
be forfeited by a first approved applicant if
the applicant fails to market the competitive
generic therapy within 75 days after the date
on which the approval of the first approved
applicant's application for the competitive
generic therapy is made effective.
(E) If the Secretary decides to disapprove an application,
the Secretary shall give the applicant notice of an opportunity
for a hearing before the Secretary on the question of whether
such application is approvable. If the applicant elects to
accept the opportunity for hearing by written request within
thirty days after such notice, such hearing shall commence not
more than ninety days after the expiration of such thirty days
unless the Secretary and the applicant otherwise agree. Any
such hearing shall thereafter be conducted on an expedited
basis and the Secretary's order thereon shall be issued within
ninety days after the date fixed by the Secretary for filing
final briefs.
(F)(i) If an application (other than an abbreviated new drug
application) submitted under subsection (b) for a drug, no
active ingredient (including any ester or salt of the active
ingredient) of which has been approved in any other application
under subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted
effective before the expiration of ten years from the date of
the approval of the application under subsection (b).
(ii) If an application submitted under subsection (b) for a
drug, no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under subsection (b), is approved after the date of
the enactment of this subsection, no application may be
submitted under this subsection which refers to the drug for
which the subsection (b) application was submitted before the
expiration of five years from the date of the approval of the
application under subsection (b), except that such an
application may be submitted under this subsection after the
expiration of four years from the date of the approval of the
subsection (b) application if it contains a certification of
patent invalidity or noninfringement described in subclause
(IV) of paragraph (2)(A)(vii). The approval of such an
application shall be made effective in accordance with
subparagraph (B) except that, if an action for patent
infringement is commenced during the one-year period beginning
forty-eight months after the date of the approval of the
subsection (b) application, the thirty-month period referred to
in subparagraph (B)(iii) shall be extended by such amount of
time (if any) which is required for seven and one-half years to
have elapsed from the date of approval of the subsection (b)
application.
(iii) If an application submitted under subsection (b) for a
drug, which includes an active ingredient (including any ester
or salt of the active ingredient) that has been approved in
another application approved under subsection (b), is approved
after the date of enactment of this subsection and if such
application contains reports of new clinical investigations
(other than bioavailability studies) essential to the approval
of the application and conducted or sponsored by the applicant,
the Secretary may not make the approval of an application
submitted under this subsection for the conditions of approval
of such drug in the subsection (b) application effective before
the expiration of three years from the date of the approval of
the application under subsection (b) for such drug.
(iv) If a supplement to an application approved under
subsection (b) is approved after the date of enactment of this
subsection and the supplement contains reports of new clinical
investigations (other than bioavailability studies) essential
to the approval of the supplement and conducted or sponsored by
the person submitting the supplement, the Secretary may not
make the approval of an application submitted under this
subsection for a change approved in the supplement effective
before the expiration of three years from the date of the
approval of the supplement under subsection (b).
(v) If an application (or supplement to an application)
submitted under subsection (b) for a drug, which includes an
active ingredient (including any ester or salt of the active
ingredient) that has been approved in another application under
subsection (b), was approved during the period beginning
January 1, 1982, and ending on the date of the enactment of
this subsection, the Secretary may not make the approval of an
application submitted under this subsection which refers to the
drug for which the subsection (b) application was submitted or
which refers to a change approved in a supplement to the
subsection (b) application effective before the expiration of
two years from the date of enactment of this subsection.
(6) If a drug approved under this subsection refers in its
approved application to a drug the approval of which was
withdrawn or suspended for grounds described in the first
sentence of subsection (e) or was withdrawn or suspended under
this paragraph or which, as determined by the Secretary, has
been withdrawn from sale for safety or effectiveness reasons,
the approval of the drug under this subsection shall be
withdrawn or suspended--
(A) for the same period as the withdrawal or
suspension under subsection (e) or this paragraph, or
(B) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
(7)(A)(i) Within sixty days of the date of the enactment of
this subsection, the Secretary shall publish and make available
to the public--
(I) a list in alphabetical order of the official and
proprietary name of each drug which has been approved
for safety and effectiveness under subsection (c)
before the date of the enactment of this subsection;
(II) the date of approval if the drug is approved
after 1981 and the number of the application which was
approved; and
(III) whether in vitro or in vivo bioequivalence
studies, or both such studies, are required for
applications filed under this subsection which will
refer to the drug published.
(ii) Every thirty days after the publication of the first
list under clause (i) the Secretary shall revise the list to
include each drug which has been approved for safety and
effectiveness under subsection (c) or approved under this
subsection during the thirty-day period.
(iii) When patent information submitted under subsection (b)
or (c) respecting a drug included on the list is to be
published by the Secretary, the Secretary shall, in revisions
made under clause (ii), include such information for such drug.
(B) A drug approved for safety and effectiveness under
subsection (c) or approved under this subsection shall, for
purposes of this subsection, be considered to have been
published under subparagraph (A) on the date of its approval or
the date of enactment, whichever is later.
(C) If the approval of a drug was withdrawn or suspended for
grounds described in the first sentence of subsection (e) or
was withdrawn or suspended under paragraph (6) or if the
Secretary determines that a drug has been withdrawn from sale
for safety or effectiveness reasons, it may not be published in
the list under subparagraph (A) or, if the withdrawal or
suspension occurred after its publication in such list, it
shall be immediately removed from such list--
(i) for the same period as the withdrawal or
suspension under subsection (e) or paragraph (6), or
(ii) if the listed drug has been withdrawn from sale,
for the period of withdrawal from sale or, if earlier,
the period ending on the date the Secretary determines
that the withdrawal from sale is not for safety or
effectiveness reasons.
A notice of the removal shall be published in the Federal
Register.
(8) For purposes of this subsection:
(A)(i) The term ``bioavailability'' means the rate
and extent to which the active ingredient or
therapeutic ingredient is absorbed from a drug and
becomes available at the site of drug action.
(ii) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may assess
bioavailability by scientifically valid measurements
intended to reflect the rate and extent to which the
active ingredient or therapeutic ingredient becomes
available at the site of drug action.
(B) A drug shall be considered to be bioequivalent to
a listed drug if--
(i) the rate and extent of absorption of the
drug do not show a significant difference from
the rate and extent of absorption of the listed
drug when administered at the same molar dose
of the therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses; or
(ii) the extent of absorption of the drug
does not show a significant difference from the
extent of absorption of the listed drug when
administered at the same molar dose of the
therapeutic ingredient under similar
experimental conditions in either a single dose
or multiple doses and the difference from the
listed drug in the rate of absorption of the
drug is intentional, is reflected in its
proposed labeling, is not essential to the
attainment of effective body drug
concentrations on chronic use, and is
considered medically insignificant for the
drug.
(C) For a drug that is not intended to be absorbed
into the bloodstream, the Secretary may establish
alternative, scientifically valid methods to show
bioequivalence if the alternative methods are expected
to detect a significant difference between the drug and
the listed drug in safety and therapeutic effect.
(9) The Secretary shall, with respect to each application
submitted under this subsection, maintain a record of--
(A) the name of the applicant,
(B) the name of the drug covered by the application,
(C) the name of each person to whom the review of the
chemistry of the application was assigned and the date
of such assignment, and
(D) the name of each person to whom the
bioequivalence review for such application was assigned
and the date of such assignment.
The information the Secretary is required to maintain under
this paragraph with respect to an application submitted under
this subsection shall be made available to the public after the
approval of such application.
(10)(A) If the proposed labeling of a drug that is the
subject of an application under this subsection differs from
the listed drug due to a labeling revision described under
clause (i), the drug that is the subject of such application
shall, notwithstanding any other provision of this Act, be
eligible for approval and shall not be considered misbranded
under section 502 if--
(i) the application is otherwise eligible for
approval under this subsection but for expiration of
patent, an exclusivity period, or of a delay in
approval described in paragraph (5)(B)(iii), and a
revision to the labeling of the listed drug has been
approved by the Secretary within 60 days of such
expiration;
(ii) the labeling revision described under clause (i)
does not include a change to the ``Warnings'' section
of the labeling;
(iii) the sponsor of the application under this
subsection agrees to submit revised labeling of the
drug that is the subject of such application not later
than 60 days after the notification of any changes to
such labeling required by the Secretary; and
(iv) such application otherwise meets the applicable
requirements for approval under this subsection.
(B) If, after a labeling revision described in subparagraph
(A)(i), the Secretary determines that the continued presence in
interstate commerce of the labeling of the listed drug (as in
effect before the revision described in subparagraph (A)(i))
adversely impacts the safe use of the drug, no application
under this subsection shall be eligible for approval with such
labeling.
(11)(A) Subject to subparagraph (B), the Secretary shall
prioritize the review of, and act within 8 months of the date
of the submission of, an original abbreviated new drug
application submitted for review under this subsection that is
for a drug--
(i) for which there are not more than 3 approved drug
products listed under paragraph (7) and for which there
are no blocking patents and exclusivities; or
(ii) that has been included on the list under section
506E.
(B) To qualify for priority review under this paragraph, not
later than 60 days prior to the submission of an application
described in subparagraph (A) or that the Secretary may
prioritize pursuant to subparagraph (D), the applicant shall
provide complete, accurate information regarding facilities
involved in manufacturing processes and testing of the drug
that is the subject of the application, including facilities in
corresponding Type II active pharmaceutical ingredients drug
master files referenced in an application and sites or
organizations involved in bioequivalence and clinical studies
used to support the application, to enable the Secretary to
make a determination regarding whether an inspection of a
facility is necessary. Such information shall include the
relevant (as determined by the Secretary) sections of such
application, which shall be unchanged relative to the date of
the submission of such application, except to the extent that a
change is made to such information to exclude a facility that
was not used to generate data to meet any application
requirements for such submission and that is not the only
facility intended to conduct one or more unit operations in
commercial production. Information provided by an applicant
under this subparagraph shall not be considered the submission
of an application under this subsection.
(C) The Secretary may expedite an inspection or reinspection
under section 704 of an establishment that proposes to
manufacture a drug described in subparagraph (A).
(D) Nothing in this paragraph shall prevent the Secretary
from prioritizing the review of other applications as the
Secretary determines appropriate.
(12) The Secretary shall publish on the internet website of
the Food and Drug Administration, and update at least once
every 6 months, a list of all drugs approved under subsection
(c) for which all patents and periods of exclusivity under this
Act have expired and for which no application has been approved
under this subsection.
(13) Upon the request of an applicant regarding one or more
specified pending applications under this subsection, the
Secretary shall, as appropriate, provide review status updates
indicating the categorical status of the applications by each
relevant review discipline.
(k)(1) In the case of any drug for which an approval of an
application filed under subsection (b) or (j) is in effect, the
applicant shall establish and maintain such records, and make
such reports to the Secretary, of data relating to clinical
experience and other data or information, received or otherwise
obtained by such applicant with respect to such drug, as the
Secretary may by general regulation, or by order with respect
to such application, prescribe on the basis of a finding that
such records and reports are necessary in order to enable the
Secretary to determine, or facilitate a determination, whether
there is or may be ground for invoking subsection (e) of this
section. Regulations and orders issued under this subsection
and under subsection (i) shall have due regard for the
professional ethics of the medical profession and the interests
of patients and shall provide, where the Secretary deems it to
be appropriate, for the examination, upon request, by the
persons to whom such regulations or orders are applicable, of
similar information received or otherwise obtained by the
Secretary.
(2) Every person required under this section to maintain
records, and every person in charge or custody thereof, shall,
upon request of an officer or employee designated by the
Secretary, permit such officer or employee at all reasonable
times to have access to and copy and verify such records.
(3) Active postmarket risk identification.--
(A) Definition.--In this paragraph, the term
``data'' refers to information with respect to
a drug approved under this section or under
section 351 of the Public Health Service Act,
including claims data, patient survey data,
standardized analytic files that allow for the
pooling and analysis of data from disparate
data environments, and any other data deemed
appropriate by the Secretary.
(B) Development of postmarket risk
identification and analysis methods.--The
Secretary shall, not later than 2 years after
the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, in
collaboration with public, academic, and
private entities--
(i) develop methods to obtain access
to disparate data sources including the
data sources specified in subparagraph
(C);
(ii) develop validated methods for
the establishment of a postmarket risk
identification and analysis system to
link and analyze safety data from
multiple sources, with the goals of
including, in aggregate--
(I) at least 25,000,000
patients by July 1, 2010; and
(II) at least 100,000,000
patients by July 1, 2012; and
(iii) convene a committee of experts,
including individuals who are
recognized in the field of protecting
data privacy and security, to make
recommendations to the Secretary on the
development of tools and methods for
the ethical and scientific uses for,
and communication of, postmarketing
data specified under subparagraph (C),
including recommendations on the
development of effective research
methods for the study of drug safety
questions.
(C) Establishment of the postmarket risk
identification and analysis system.--
(i) In general.--The Secretary shall,
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), establish and maintain
procedures--
(I) for risk identification
and analysis based on
electronic health data, in
compliance with the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996, and in a manner
that does not disclose
individually identifiable
health information in violation
of paragraph (4)(B);
(II) for the reporting (in a
standardized form) of data on
all serious adverse drug
experiences (as defined in
section 505-1(b)) submitted to
the Secretary under paragraph
(1), and those adverse events
submitted by patients,
providers, and drug sponsors,
when appropriate;
(III) to provide for active
adverse event surveillance
using the following data
sources, as available:
(aa) Federal health-
related electronic data
(such as data from the
Medicare program and
the health systems of
the Department of
Veterans Affairs);
(bb) private sector
health-related
electronic data (such
as pharmaceutical
purchase data and
health insurance claims
data); and
(cc) other data as
the Secretary deems
necessary to create a
robust system to
identify adverse events
and potential drug
safety signals;
(IV) to identify certain
trends and patterns with
respect to data accessed by the
system;
(V) to provide regular
reports to the Secretary
concerning adverse event
trends, adverse event patterns,
incidence and prevalence of
adverse events, and other
information the Secretary
determines appropriate, which
may include data on comparative
national adverse event trends;
and
(VI) to enable the program to
export data in a form
appropriate for further
aggregation, statistical
analysis, and reporting.
(ii) Timeliness of reporting.--The
procedures established under clause (i)
shall ensure that such data are
accessed, analyzed, and reported in a
timely, routine, and systematic manner,
taking into consideration the need for
data completeness, coding, cleansing,
and standardized analysis and
transmission.
(iii) Private sector resources.--To
ensure the establishment of the active
postmarket risk identification and
analysis system under this subsection
not later than 1 year after the
development of the risk identification
and analysis methods under subparagraph
(B), as required under clause (i), the
Secretary may, on a temporary or
permanent basis, implement systems or
products developed by private entities.
(iv) Complementary approaches.--To
the extent the active postmarket risk
identification and analysis system
under this subsection is not sufficient
to gather data and information relevant
to a priority drug safety question, the
Secretary shall develop, support, and
participate in complementary approaches
to gather and analyze such data and
information, including--
(I) approaches that are
complementary with respect to
assessing the safety of use of
a drug in domestic populations
not included, or
underrepresented, in the trials
used to approve the drug (such
as older people, people with
comorbidities, pregnant women,
or children); and
(II) existing approaches such
as the Vaccine Adverse Event
Reporting System and the
Vaccine Safety Datalink or
successor databases.
(v) Authority for contracts.--The
Secretary may enter into contracts with
public and private entities to fulfill
the requirements of this subparagraph.
(4) Advanced analysis of drug safety data.--
(A) Purpose.--The Secretary shall establish
collaborations with public, academic, and
private entities, which may include the Centers
for Education and Research on Therapeutics
under section 912 of the Public Health Service
Act, to provide for advanced analysis of drug
safety data described in paragraph (3)(C) and
other information that is publicly available or
is provided by the Secretary, in order to--
(i) improve the quality and
efficiency of postmarket drug safety
risk-benefit analysis;
(ii) provide the Secretary with
routine access to outside expertise to
study advanced drug safety questions;
and
(iii) enhance the ability of the
Secretary to make timely assessments
based on drug safety data.
(B) Privacy.--Such analysis shall not
disclose individually identifiable health
information when presenting such drug safety
signals and trends or when responding to
inquiries regarding such drug safety signals
and trends.
(C) Public process for priority questions.--
At least biannually, the Secretary shall seek
recommendations from the Drug Safety and Risk
Management Advisory Committee (or any successor
committee) and from other advisory committees,
as appropriate, to the Food and Drug
Administration on--
(i) priority drug safety questions;
and
(ii) mechanisms for answering such
questions, including through--
(I) active risk
identification under paragraph
(3); and
(II) when such risk
identification is not
sufficient, postapproval
studies and clinical trials
under subsection (o)(3).
(D) Procedures for the development of drug
safety collaborations.--
(i) In general.--Not later than 180
days after the date of the
establishment of the active postmarket
risk identification and analysis system
under this subsection, the Secretary
shall establish and implement
procedures under which the Secretary
may routinely contract with one or more
qualified entities to--
(I) classify, analyze, or
aggregate data described in
paragraph (3)(C) and
information that is publicly
available or is provided by the
Secretary;
(II) allow for prompt
investigation of priority drug
safety questions, including--
(aa) unresolved
safety questions for
drugs or classes of
drugs; and
(bb) for a newly-
approved drugs, safety
signals from clinical
trials used to approve
the drug and other
preapproval trials;
rare, serious drug side
effects; and the safety
of use in domestic
populations not
included, or
underrepresented, in
the trials used to
approve the drug (such
as older people, people
with comorbidities,
pregnant women, or
children);
(III) perform advanced
research and analysis on
identified drug safety risks;
(IV) focus postapproval
studies and clinical trials
under subsection (o)(3) more
effectively on cases for which
reports under paragraph (1) and
other safety signal detection
is not sufficient to resolve
whether there is an elevated
risk of a serious adverse event
associated with the use of a
drug; and
(V) carry out other
activities as the Secretary
deems necessary to carry out
the purposes of this paragraph.
(ii) Request for specific
methodology.--The procedures described
in clause (i) shall permit the
Secretary to request that a specific
methodology be used by the qualified
entity. The qualified entity shall work
with the Secretary to finalize the
methodology to be used.
(E) Use of analyses.--The Secretary shall
provide the analyses described in this
paragraph, including the methods and results of
such analyses, about a drug to the sponsor or
sponsors of such drug.
(F) Qualified entities.--
(i) In general.--The Secretary shall
enter into contracts with a sufficient
number of qualified entities to develop
and provide information to the
Secretary in a timely manner.
(ii) Qualification.--The Secretary
shall enter into a contract with an
entity under clause (i) only if the
Secretary determines that the entity
has a significant presence in the
United States and has one or more of
the following qualifications:
(I) The research,
statistical, epidemiologic, or
clinical capability and
expertise to conduct and
complete the activities under
this paragraph, including the
capability and expertise to
provide the Secretary de-
identified data consistent with
the requirements of this
subsection.
(II) An information
technology infrastructure in
place to support electronic
data and operational standards
to provide security for such
data.
(III) Experience with, and
expertise on, the development
of drug safety and
effectiveness research using
electronic population data.
(IV) An understanding of drug
development or risk/benefit
balancing in a clinical
setting.
(V) Other expertise which the
Secretary deems necessary to
fulfill the activities under
this paragraph.
(G) Contract requirements.--Each contract
with a qualified entity under subparagraph
(F)(i) shall contain the following
requirements:
(i) Ensuring privacy.--The qualified
entity shall ensure that the entity
will not use data under this subsection
in a manner that--
(I) violates the regulations
promulgated under section
264(c) of the Health Insurance
Portability and Accountability
Act of 1996;
(II) violates sections 552 or
552a of title 5, United States
Code, with regard to the
privacy of individually-
identifiable beneficiary health
information; or
(III) discloses individually
identifiable health information
when presenting drug safety
signals and trends or when
responding to inquiries
regarding drug safety signals
and trends.
Nothing in this clause prohibits lawful
disclosure for other purposes.
(ii) Component of another
organization.--If a qualified entity is
a component of another organization--
(I) the qualified entity
shall establish appropriate
security measures to maintain
the confidentiality and privacy
of such data; and
(II) the entity shall not
make an unauthorized disclosure
of such data to the other
components of the organization
in breach of such
confidentiality and privacy
requirement.
(iii) Termination or nonrenewal.--If
a contract with a qualified entity
under this subparagraph is terminated
or not renewed, the following
requirements shall apply:
(I) Confidentiality and
privacy protections.--The
entity shall continue to comply
with the confidentiality and
privacy requirements under this
paragraph with respect to all
data disclosed to the entity.
(II) Disposition of data.--
The entity shall return any
data disclosed to such entity
under this subsection to which
it would not otherwise have
access or, if returning the
data is not practicable,
destroy the data.
(H) Competitive procedures.--The Secretary
shall use competitive procedures (as defined in
section 4(5) of the Federal Procurement Policy
Act) to enter into contracts under subparagraph
(G).
(I) Review of contract in the event of a
merger or acquisition.--The Secretary shall
review the contract with a qualified entity
under this paragraph in the event of a merger
or acquisition of the entity in order to ensure
that the requirements under this paragraph will
continue to be met.
(J) Coordination.--In carrying out this
paragraph, the Secretary shall provide for
appropriate communications to the public,
scientific, public health, and medical
communities, and other key stakeholders, and to
the extent practicable shall coordinate with
the activities of private entities,
professional associations, or other entities
that may have sources of drug safety data.
(5) The Secretary shall--
(A) conduct regular screenings of the Adverse
Event Reporting System database and post a
quarterly report on the Adverse Event Reporting
System Web site of any new safety information
or potential signal of a serious risk
identified by Adverse Event Reporting System
within the last quarter; and
(B) on an annual basis, review the entire
backlog of postmarket safety commitments to
determine which commitments require revision or
should be eliminated, report to the Congress on
these determinations, and assign start dates
and estimated completion dates for such
commitments; and
(C) make available on the Internet website of the
Food and Drug Administration--
(i) guidelines, developed with input from
experts qualified by scientific training and
experience to evaluate the safety and
effectiveness of drugs, that detail best
practices for drug safety surveillance using
the Adverse Event Reporting System; and
(ii) criteria for public posting of adverse
event signals.
(l)(1) Safety and effectiveness data and information which
has been submitted in an application under subsection (b) for a
drug and which has not previously been disclosed to the public
shall be made available to the public, upon request, unless
extraordinary circumstances are shown--
(A) if no work is being or will be undertaken to have
the application approved,
(B) if the Secretary has determined that the
application is not approvable and all legal appeals
have been exhausted,
(C) if approval of the application under subsection
(c) is withdrawn and all legal appeals have been
exhausted,
(D) if the Secretary has determined that such drug is
not a new drug, or
(E) upon the effective date of the approval of the
first application under subsection (j) which refers to
such drug or upon the date upon which the approval of
an application under subsection (j) which refers to
such drug could be made effective if such an
application had been submitted.
(2) Action Package for Approval.--
(A) Action package.--The Secretary shall publish the
action package for approval of an application under
subsection (b) or section 351 of the Public Health
Service Act on the Internet Web site of the Food and
Drug Administration--
(i) not later than 30 days after the date of
approval of such application for a drug no
active ingredient (including any ester or salt
of the active ingredient) of which has been
approved in any other application under this
section or section 351 of the Public Health
Service Act; and
(ii) not later than 30 days after the third
request for such action package for approval
received under section 552 of title 5, United
States Code, for any other drug.
(B) Immediate publication of summary review.--
Notwithstanding subparagraph (A), the Secretary shall
publish, on the Internet Web site of the Food and Drug
Administration, the materials described in subparagraph
(C)(iv) not later than 48 hours after the date of
approval of the drug, except where such materials
require redaction by the Secretary.
(C) Contents.--An action package for approval of an
application under subparagraph (A) shall be dated and
shall include the following:
(i) Documents generated by the Food and Drug
Administration related to review of the
application.
(ii) Documents pertaining to the format and
content of the application generated during
drug development.
(iii) Labeling submitted by the applicant.
(iv) A summary review that documents
conclusions from all reviewing disciplines
about the drug, noting any critical issues and
disagreements with the applicant and within the
review team and how they were resolved,
recommendations for action, and an explanation
of any nonconcurrence with review conclusions.
(v) The Division Director and Office
Director's decision document which includes--
(I) a brief statement of concurrence
with the summary review;
(II) a separate review or addendum to
the review if disagreeing with the
summary review; and
(III) a separate review or addendum
to the review to add further analysis.
(vi) Identification by name of each officer
or employee of the Food and Drug Administration
who--
(I) participated in the decision to
approve the application; and
(II) consents to have his or her name
included in the package.
(D) Review.--A scientific review of an application is
considered the work of the reviewer and shall not be
altered by management or the reviewer once final.
(E) Confidential information.--This paragraph does
not authorize the disclosure of any trade secret,
confidential commercial or financial information, or
other matter listed in section 552(b) of title 5,
United States Code.
(m) For purposes of this section, the term ``patent'' means a
patent issued by the United States Patent and Trademark Office.
(n)(1) For the purpose of providing expert scientific advice
and recommendations to the Secretary regarding a clinical
investigation of a drug or the approval for marketing of a drug
under section 505 or section 351 of the Public Health Service
Act, the Secretary shall establish panels of experts or use
panels of experts established before the date of enactment of
the Food and Drug Administration Modernization Act of 1997, or
both.
(2) The Secretary may delegate the appointment and oversight
authority granted under section 1004 to a director of a center
or successor entity within the Food and Drug Administration.
(3) The Secretary shall make appointments to each panel
established under paragraph (1) so that each panel shall
consist of--
(A) members who are qualified by training and
experience to evaluate the safety and effectiveness of
the drugs to be referred to the panel and who, to the
extent feasible, possess skill and experience in the
development, manufacture, or utilization of such drugs;
(B) members with diverse expertise in such fields as
clinical and administrative medicine, pharmacy,
pharmacology, pharmacoeconomics, biological and
physical sciences, and other related professions;
(C) a representative of consumer interests, and a
representative of interests of the drug manufacturing
industry not directly affected by the matter to be
brought before the panel; and
(D) two or more members who are specialists or have
other expertise in the particular disease or condition
for which the drug under review is proposed to be
indicated.
Scientific, trade, and consumer organizations shall be afforded
an opportunity to nominate individuals for appointment to the
panels. No individual who is in the regular full-time employ of
the United States and engaged in the administration of this Act
may be a voting member of any panel. The Secretary shall
designate one of the members of each panel to serve as chairman
thereof.
(4) The Secretary shall, as appropriate, provide education
and training to each new panel member before such member
participates in a panel's activities, including education
regarding requirements under this Act and related regulations
of the Secretary, and the administrative processes and
procedures related to panel meetings.
(5) Panel members (other than officers or employees of the
United States), while attending meetings or conferences of a
panel or otherwise engaged in its business, shall be entitled
to receive compensation for each day so engaged, including
traveltime, at rates to be fixed by the Secretary, but not to
exceed the daily equivalent of the rate in effect for positions
classified above grade GS-15 of the General Schedule. While
serving away from their homes or regular places of business,
panel members may be allowed travel expenses (including per
diem in lieu of subsistence) as authorized by section 5703 of
title 5, United States Code, for persons in the Government
service employed intermittently.
(6) The Secretary shall ensure that scientific advisory
panels meet regularly and at appropriate intervals so that any
matter to be reviewed by such a panel can be presented to the
panel not more than 60 days after the matter is ready for such
review. Meetings of the panel may be held using electronic
communication to convene the meetings.
(7) Within 90 days after a scientific advisory panel makes
recommendations on any matter under its review, the Food and
Drug Administration official responsible for the matter shall
review the conclusions and recommendations of the panel, and
notify the affected persons of the final decision on the
matter, or of the reasons that no such decision has been
reached. Each such final decision shall be documented including
the rationale for the decision.
(o) Postmarket Studies and Clinical Trials; Labeling.--
(1) In general.--A responsible person may not
introduce or deliver for introduction into interstate
commerce the new drug involved if the person is in
violation of a requirement established under paragraph
(3) or (4) with respect to the drug.
(2) Definitions.--For purposes of this subsection:
(A) Responsible person.--The term
``responsible person'' means a person who--
(i) has submitted to the Secretary a
covered application that is pending; or
(ii) is the holder of an approved
covered application.
(B) Covered application.--The term ``covered
application'' means--
(i) an application under subsection
(b) for a drug that is subject to
section 503(b); and
(ii) an application under section 351
of the Public Health Service Act.
(C) New safety information; serious risk.--
The terms ``new safety information'', ``serious
risk'', and ``signal of a serious risk'' have
the meanings given such terms in section 505-
1(b).
(3) Studies and clinical trials.--
(A) In general.--For any or all of the
purposes specified in subparagraph (B), the
Secretary may, subject to subparagraph (D),
require a responsible person for a drug to
conduct a postapproval study or studies of the
drug, or a postapproval clinical trial or
trials of the drug, on the basis of scientific
data deemed appropriate by the Secretary,
including information regarding chemically-
related or pharmacologically-related drugs.
(B) Purposes of study or clinical trial.--The
purposes referred to in this subparagraph with
respect to a postapproval study or postapproval
clinical trial are the following:
(i) To assess a known serious risk
related to the use of the drug
involved.
(ii) To assess signals of serious
risk related to the use of the drug.
(iii) To identify an unexpected
serious risk when available data
indicates the potential for a serious
risk.
(C) Establishment of requirement after
approval of covered application.--The Secretary
may require a postapproval study or studies or
postapproval clinical trial or trials for a
drug for which an approved covered application
is in effect as of the date on which the
Secretary seeks to establish such requirement
only if the Secretary becomes aware of new
safety information.
(D) Determination by secretary.--
(i) Postapproval studies.--The
Secretary may not require the
responsible person to conduct a study
under this paragraph, unless the
Secretary makes a determination that
the reports under subsection (k)(1) and
the active postmarket risk
identification and analysis system as
available under subsection (k)(3) will
not be sufficient to meet the purposes
set forth in subparagraph (B).
(ii) Postapproval clinical trials.--
The Secretary may not require the
responsible person to conduct a
clinical trial under this paragraph,
unless the Secretary makes a
determination that a postapproval study
or studies will not be sufficient to
meet the purposes set forth in
subparagraph (B).
(E) Notification; timetables; periodic
reports.--
(i) Notification.--The Secretary
shall notify the responsible person
regarding a requirement under this
paragraph to conduct a postapproval
study or clinical trial by the target
dates for communication of feedback
from the review team to the responsible
person regarding proposed labeling and
postmarketing study commitments as set
forth in the letters described in
section 101(c) of the Food and Drug
Administration Amendments Act of 2007.
(ii) Timetable; periodic reports.--
For each study or clinical trial
required to be conducted under this
paragraph, the Secretary shall require
that the responsible person submit a
timetable for completion of the study
or clinical trial. With respect to each
study required to be conducted under
this paragraph or otherwise undertaken
by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such study
including whether any difficulties in
completing the study have been
encountered. With respect to each
clinical trial required to be conducted
under this paragraph or otherwise
undertaken by the responsible person to
investigate a safety issue, the
Secretary shall require the responsible
person to periodically report to the
Secretary on the status of such
clinical trial including whether
enrollment has begun, the number of
participants enrolled, the expected
completion date, whether any
difficulties completing the clinical
trial have been encountered, and
registration information with respect
to the requirements under section
402(j) of the Public Health Service
Act. If the responsible person fails to
comply with such timetable or violates
any other requirement of this
subparagraph, the responsible person
shall be considered in violation of
this subsection, unless the responsible
person demonstrates good cause for such
noncompliance or such other violation.
The Secretary shall determine what
constitutes good cause under the
preceding sentence.
(F) Dispute resolution.--The responsible
person may appeal a requirement to conduct a
study or clinical trial under this paragraph
using dispute resolution procedures established
by the Secretary in regulation and guidance.
(4) Safety labeling changes requested by secretary.--
(A) New safety or new effectiveness
information.--If the Secretary becomes aware of
new information, including any new safety
information or information related to reduced
effectiveness, that the Secretary determines
should be included in the labeling of the drug,
the Secretary shall promptly notify the
responsible person or, if the same drug
approved under section 505(b) is not currently
marketed, the holder of an approved application
under 505(j).
(B) Response to notification.--Following
notification pursuant to subparagraph (A), the
responsible person or the holder of the
approved application under section 505(j) shall
within 30 days--
(i) submit a supplement proposing
changes to the approved labeling to
reflect the new safety information,
including changes to boxed warnings,
contraindications, warnings,
precautions, or adverse reactions, or
new effectiveness information; or
(ii) notify the Secretary that the
responsible person or the holder of the
approved application under section
505(j) does not believe a labeling
change is warranted and submit a
statement detailing the reasons why
such a change is not warranted.
(C) Review.--Upon receipt of such supplement,
the Secretary shall promptly review and act
upon such supplement. If the Secretary
disagrees with the proposed changes in the
supplement or with the statement setting forth
the reasons why no labeling change is
necessary, the Secretary shall initiate
discussions to reach agreement on whether the
labeling for the drug should be modified to
reflect the new safety or new effectiveness
information, and if so, the contents of such
labeling changes.
(D) Discussions.--Such discussions shall not
extend for more than 30 days after the response
to the notification under subparagraph (B),
unless the Secretary determines an extension of
such discussion period is warranted.
(E) Order.--Within 15 days of the conclusion
of the discussions under subparagraph (D), the
Secretary may issue an order directing the
responsible person or the holder of the
approved application under section 505(j) to
make such a labeling change as the Secretary
deems appropriate to address the new safety or
new effectiveness information. Within 15 days
of such an order, the responsible person or the
holder of the approved application under
section 505(j) shall submit a supplement
containing the labeling change.
(F) Dispute resolution.--Within 5 days of
receiving an order under subparagraph (E), the
responsible person or the holder of the
approved application under section 505(j) may
appeal using dispute resolution procedures
established by the Secretary in regulation and
guidance.
(G) Violation.--If the responsible person or
the holder of the approved application under
section 505(j) has not submitted a supplement
within 15 days of the date of such order under
subparagraph (E), and there is no appeal or
dispute resolution proceeding pending, the
responsible person or holder shall be
considered to be in violation of this
subsection. If at the conclusion of any dispute
resolution procedures the Secretary determines
that a supplement must be submitted and such a
supplement is not submitted within 15 days of
the date of that determination, the responsible
person or holder shall be in violation of this
subsection.
(H) Public health threat.--Notwithstanding
subparagraphs (A) through (F), if the Secretary
concludes that such a labeling change is
necessary to protect the public health, the
Secretary may accelerate the timelines in such
subparagraphs.
(I) Rule of construction.--This paragraph
shall not be construed to affect the
responsibility of the responsible person or the
holder of the approved application under
section 505(j) to maintain its label in
accordance with existing requirements,
including subpart B of part 201 and sections
314.70 and 601.12 of title 21, Code of Federal
Regulations (or any successor regulations).
(5) Non-delegation.--Determinations by the Secretary
under this subsection for a drug shall be made by
individuals at or above the level of individuals
empowered to approve a drug (such as division directors
within the Center for Drug Evaluation and Research).
(p) Risk Evaluation and Mitigation Strategy.--
(1) In general.--A person may not introduce or
deliver for introduction into interstate commerce a new
drug if--
(A)(i) the application for such drug is
approved under subsection (b) or (j) and is
subject to section 503(b); or
(ii) the application for such drug is
approved under section 351 of the Public Health
Service Act; and
(B) a risk evaluation and mitigation strategy
is required under section 505-1 with respect to
the drug and the person fails to maintain
compliance with the requirements of the
approved strategy or with other requirements
under section 505-1, including requirements
regarding assessments of approved strategies.
(2) Certain postmarket studies.--The failure to
conduct a postmarket study under section 506, subpart H
of part 314, or subpart E of part 601 of title 21, Code
of Federal Regulations (or any successor regulations),
is deemed to be a violation of paragraph (1).
(q) Petitions and Civil Actions Regarding Approval of Certain
Applications.--
(1) In general.--
(A) Determination.--The Secretary shall not
delay approval of a pending application
submitted under subsection (b)(2) or (j) of
this section or section 351(k) of the Public
Health Service Act because of any request to
take any form of action relating to the
application, either before or during
consideration of the request, unless--
(i) the request is in writing and is
a petition submitted to the Secretary
pursuant to section 10.30 or 10.35 of
title 21, Code of Federal Regulations
(or any successor regulations); and
(ii) the Secretary determines, upon
reviewing the petition, that a delay is
necessary to protect the public health.
Consideration of the petition shall be separate
and apart from review and approval of any
application.
(B) Notification.--If the Secretary
determines under subparagraph (A) that a delay
is necessary with respect to an application,
the Secretary shall provide to the applicant,
not later than 30 days after making such
determination, the following information:
(i) Notification of the fact that a
determination under subparagraph (A)
has been made.
(ii) If applicable, any clarification
or additional data that the applicant
should submit to the docket on the
petition to allow the Secretary to
review the petition promptly.
(iii) A brief summary of the specific
substantive issues raised in the
petition which form the basis of the
determination.
(C) Format.--The information described in
subparagraph (B) shall be conveyed via either,
at the discretion of the Secretary--
(i) a document; or
(ii) a meeting with the applicant
involved.
(D) Public disclosure.--Any information
conveyed by the Secretary under subparagraph
(C) shall be considered part of the application
and shall be subject to the disclosure
requirements applicable to information in such
application.
(E) Denial based on intent to delay.--If the
Secretary determines that a petition or a
supplement to the petition was submitted with
the primary purpose of delaying the approval of
an application and the petition does not on its
face raise valid scientific or regulatory
issues, the Secretary may deny the petition at
any point based on such determination. The
Secretary may issue guidance to describe the
factors that will be used to determine under
this subparagraph whether a petition is
submitted with the primary purpose of delaying
the approval of an application.
(F) Final agency action.--The Secretary shall
take final agency action on a petition not
later than 150 days after the date on which the
petition is submitted. The Secretary shall not
extend such period for any reason, including--
(i) any determination made under
subparagraph (A);
(ii) the submission of comments
relating to the petition or
supplemental information supplied by
the petitioner; or
(iii) the consent of the petitioner.
(G) Extension of 30-month period.--If the
filing of an application resulted in first-
applicant status under subsection
(j)(5)(D)(i)(IV) and approval of the
application was delayed because of a petition,
the 30-month period under such subsection is
deemed to be extended by a period of time equal
to the period beginning on the date on which
the Secretary received the petition and ending
on the date of final agency action on the
petition (inclusive of such beginning and
ending dates), without regard to whether the
Secretary grants, in whole or in part, or
denies, in whole or in part, the petition.
(H) Certification.--The Secretary shall not
consider a petition for review unless the party
submitting such petition does so in written
form and the subject document is signed and
contains the following certification: ``I
certify that, to my best knowledge and belief:
(a) this petition includes all information and
views upon which the petition relies; (b) this
petition includes representative data and/or
information known to the petitioner which are
unfavorable to the petition; and (c) I have
taken reasonable steps to ensure that any
representative data and/or information which
are unfavorable to the petition were disclosed
to me. I further certify that the information
upon which I have based the action requested
herein first became known to the party on whose
behalf this petition is submitted on or about
the following date: __________. If I received
or expect to receive payments, including cash
and other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations:
_____________. I verify under penalty of
perjury that the foregoing is true and correct
as of the date of the submission of this
petition.'', with the date on which such
information first became known to such party
and the names of such persons or organizations
inserted in the first and second blank space,
respectively.
(I) Verification.--The Secretary shall not
accept for review any supplemental information
or comments on a petition unless the party
submitting such information or comments does so
in written form and the subject document is
signed and contains the following verification:
``I certify that, to my best knowledge and
belief: (a) I have not intentionally delayed
submission of this document or its contents;
and (b) the information upon which I have based
the action requested herein first became known
to me on or about __________. If I received or
expect to receive payments, including cash and
other forms of consideration, to file this
information or its contents, I received or
expect to receive those payments from the
following persons or organizations: _____. I
verify under penalty of perjury that the
foregoing is true and correct as of the date of
the submission of this petition.'', with the
date on which such information first became
known to the party and the names of such
persons or organizations inserted in the first
and second blank space, respectively.
(2) Exhaustion of administrative remedies.--
(A) Final agency action within 150 days.--The
Secretary shall be considered to have taken
final agency action on a petition if--
(i) during the 150-day period
referred to in paragraph (1)(F), the
Secretary makes a final decision within
the meaning of section 10.45(d) of
title 21, Code of Federal Regulations
(or any successor regulation); or
(ii) such period expires without the
Secretary having made such a final
decision.
(B) Dismissal of certain civil actions.--If a
civil action is filed against the Secretary
with respect to any issue raised in the
petition before the Secretary has taken final
agency action on the petition within the
meaning of subparagraph (A), the court shall
dismiss without prejudice the action for
failure to exhaust administrative remedies.
(C) Administrative record.--For purposes of
judicial review related to the approval of an
application for which a petition under
paragraph (1) was submitted, the administrative
record regarding any issue raised by the
petition shall include--
(i) the petition filed under
paragraph (1) and any supplements and
comments thereto;
(ii) the Secretary's response to such
petition, if issued; and
(iii) other information, as
designated by the Secretary, related to
the Secretary's determinations
regarding the issues raised in such
petition, as long as the information
was considered by the agency no later
than the date of final agency action as
defined under subparagraph (2)(A), and
regardless of whether the Secretary
responded to the petition at or before
the approval of the application at
issue in the petition.
(3) Annual report on delays in approvals per
petitions.--The Secretary shall annually submit to the
Congress a report that specifies--
(A) the number of applications that were
approved during the preceding 12-month period;
(B) the number of such applications whose
effective dates were delayed by petitions
referred to in paragraph (1) during such
period;
(C) the number of days by which such
applications were so delayed; and
(D) the number of such petitions that were
submitted during such period.
(4) Exceptions.--
(A) This subsection does not apply to--
(i) a petition that relates solely to
the timing of the approval of an
application pursuant to subsection
(j)(5)(B)(iv); or
(ii) a petition that is made by the
sponsor of an application and that
seeks only to have the Secretary take
or refrain from taking any form of
action with respect to that
application.
(B) Paragraph (2) does not apply to a
petition addressing issues concerning an
application submitted pursuant to section
351(k) of the Public Health Service Act.
(5) Definitions.--
(A) Application.--For purposes of this
subsection, the term ``application'' means an
application submitted under subsection (b)(2)
or (j) of this section or section 351(k) of the
Public Health Service Act.
(B) Petition.--For purposes of this
subsection, other than paragraph (1)(A)(i), the
term ``petition'' means a request described in
paragraph (1)(A)(i).
(r) Postmarket Drug Safety Information for Patients and
Providers.--
(1) Establishment.--Not later than 1 year after the
date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the Secretary
shall improve the transparency of information about
drugs and allow patients and health care providers
better access to information about drugs by developing
and maintaining an Internet Web site that--
(A) provides links to drug safety information
listed in paragraph (2) for prescription drugs
that are approved under this section or
licensed under section 351 of the Public Health
Service Act; and
(B) improves communication of drug safety
information to patients and providers.
(2) Internet web site.--The Secretary shall carry out
paragraph (1) by--
(A) developing and maintaining an accessible,
consolidated Internet Web site with easily
searchable drug safety information, including
the information found on United States
Government Internet Web sites, such as the
United States National Library of Medicine's
Daily Med and Medline Plus Web sites, in
addition to other such Web sites maintained by
the Secretary;
(B) ensuring that the information provided on
the Internet Web site is comprehensive and
includes, when available and appropriate--
(i) patient labeling and patient
packaging inserts;
(ii) a link to a list of each drug,
whether approved under this section or
licensed under such section 351, for
which a Medication Guide, as provided
for under part 208 of title 21, Code of
Federal Regulations (or any successor
regulations), is required;
(iii) a link to the registry and
results data bank provided for under
subsections (i) and (j) of section 402
of the Public Health Service Act;
(iv) the most recent safety
information and alerts issued by the
Food and Drug Administration for drugs
approved by the Secretary under this
section, such as product recalls,
warning letters, and import alerts;
(v) publicly available information
about implemented RiskMAPs and risk
evaluation and mitigation strategies
under subsection (o);
(vi) guidance documents and
regulations related to drug safety; and
(vii) other material determined
appropriate by the Secretary;
(C) providing access to summaries of the
assessed and aggregated data collected from the
active surveillance infrastructure under
subsection (k)(3) to provide information of
known and serious side-effects for drugs
approved under this section or licensed under
such section 351;
(D) preparing and making publicly available
on the Internet website established under
paragraph (1) best practices for drug safety
surveillance activities for drugs approved
under this section or section 351 of the Public
Health Service Act;
(E) enabling patients, providers, and drug
sponsors to submit adverse event reports
through the Internet Web site;
(F) providing educational materials for
patients and providers about the appropriate
means of disposing of expired, damaged, or
unusable medications; and
(G) supporting initiatives that the Secretary
determines to be useful to fulfill the purposes
of the Internet Web site.
(3) Posting of drug labeling.--The Secretary shall
post on the Internet Web site established under
paragraph (1) the approved professional labeling and
any required patient labeling of a drug approved under
this section or licensed under such section 351 not
later than 21 days after the date the drug is approved
or licensed, including in a supplemental application
with respect to a labeling change.
(4) Private sector resources.--To ensure development
of the Internet Web site by the date described in
paragraph (1), the Secretary may, on a temporary or
permanent basis, implement systems or products
developed by private entities.
(5) Authority for contracts.--The Secretary may enter
into contracts with public and private entities to
fulfill the requirements of this subsection.
(6) Review.--The Advisory Committee on Risk
Communication under section 567 shall, on a regular
basis, perform a comprehensive review and evaluation of
the types of risk communication information provided on
the Internet Web site established under paragraph (1)
and, through other means, shall identify, clarify, and
define the purposes and types of information available
to facilitate the efficient flow of information to
patients and providers, and shall recommend ways for
the Food and Drug Administration to work with outside
entities to help facilitate the dispensing of risk
communication information to patients and providers.
(s) Referral to Advisory Committee.--Prior to the approval of
a drug no active ingredient (including any ester or salt of the
active ingredient) of which has been approved in any other
application under this section or section 351 of the Public
Health Service Act, the Secretary shall--
(1) refer such drug to a Food and Drug Administration
advisory committee for review at a meeting of such
advisory committee; or
(2) if the Secretary does not refer such a drug to a
Food and Drug Administration advisory committee prior
to the approval of the drug, provide in the action
letter on the application for the drug a summary of the
reasons why the Secretary did not refer the drug to an
advisory committee prior to approval.
(t) Database for Authorized Generic Drugs.--
(1) In general.--
(A) Publication.--The Commissioner shall--
(i) not later than 9 months after the
date of the enactment of the Food and
Drug Administration Amendments Act of
2007, publish a complete list on the
Internet Web site of the Food and Drug
Administration of all authorized
generic drugs (including drug trade
name, brand company manufacturer, and
the date the authorized generic drug
entered the market); and
(ii) update the list quarterly to
include each authorized generic drug
included in an annual report submitted
to the Secretary by the sponsor of a
listed drug during the preceding 3-
month period.
(B) Notification.--The Commissioner shall
notify relevant Federal agencies, including the
Centers for Medicare & Medicaid Services and
the Federal Trade Commission, when the
Commissioner first publishes the information
described in subparagraph (A) that the
information has been published and that the
information will be updated quarterly.
(2) Inclusion.--The Commissioner shall include in the
list described in paragraph (1) each authorized generic
drug included in an annual report submitted to the
Secretary by the sponsor of a listed drug after January
1, 1999.
(3) Authorized generic drug.--In this section, the
term ``authorized generic drug'' means a listed drug
(as that term is used in subsection (j)) that--
(A) has been approved under subsection (c);
and
(B) is marketed, sold, or distributed
directly or indirectly to retail class of trade
under a different labeling, packaging (other
than repackaging as the listed drug in blister
packs, unit doses, or similar packaging for use
in institutions), product code, labeler code,
trade name, or trade mark than the listed drug.
(u) Certain Drugs Containing Single Enantiomers.--
(1) In general.--For purposes of subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is
submitted under subsection (b) for a non-racemic drug
containing as an active ingredient (including any ester
or salt of the active ingredient) a single enantiomer
that is contained in a racemic drug approved in another
application under subsection (b), the applicant may, in
the application for such non-racemic drug, elect to
have the single enantiomer not be considered the same
active ingredient as that contained in the approved
racemic drug, if--
(A)(i) the single enantiomer has not been
previously approved except in the approved
racemic drug; and
(ii) the application submitted under
subsection (b) for such non-racemic drug--
(I) includes full reports of new
clinical investigations (other than
bioavailability studies)--
(aa) necessary for the
approval of the application
under subsections (c) and (d);
and
(bb) conducted or sponsored
by the applicant; and
(II) does not rely on any clinical
investigations that are part of an
application submitted under subsection
(b) for approval of the approved
racemic drug; and
(B) the application submitted under
subsection (b) for such non-racemic drug is not
submitted for approval of a condition of use--
(i) in a therapeutic category in
which the approved racemic drug has
been approved; or
(ii) for which any other enantiomer
of the racemic drug has been approved.
(2) Limitation.--
(A) No approval in certain therapeutic
categories.--Until the date that is 10 years
after the date of approval of a non-racemic
drug described in paragraph (1) and with
respect to which the applicant has made the
election provided for by such paragraph, the
Secretary shall not approve such non-racemic
drug for any condition of use in the
therapeutic category in which the racemic drug
has been approved.
(B) Labeling.--If applicable, the labeling of
a non-racemic drug described in paragraph (1)
and with respect to which the applicant has
made the election provided for by such
paragraph shall include a statement that the
non-racemic drug is not approved, and has not
been shown to be safe and effective, for any
condition of use of the racemic drug.
(3) Definition.--
(A) In general.--For purposes of this
subsection, the term ``therapeutic category''
means a therapeutic category identified in the
list developed by the United States
Pharmacopeia pursuant to section 1860D-
4(b)(3)(C)(ii) of the Social Security Act and
as in effect on the date of the enactment of
this subsection.
(B) Publication by secretary.--The Secretary
shall publish the list described in
subparagraph (A) and may amend such list by
regulation.
(4) Availability.--The election referred to in
paragraph (1) may be made only in an application that
is submitted to the Secretary after the date of the
enactment of this subsection and before October 1,
2022.
(v) Antibiotic Drugs Submitted Before November 21, 1997.--
(1) Antibiotic drugs approved before november 21,
1997.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) shall be eligible for, with
respect to the drug, the 3-year exclusivity
period referred to under clauses (iii) and (iv)
of subsection (c)(3)(E) and under clauses (iii)
and (iv) of subsection (j)(5)(F), subject to
the requirements of such clauses, as
applicable.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
an application approved by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997).
(2) Antibiotic drugs submitted before november 21,
1997, but not approved.--
(A) In general.--Notwithstanding any
provision of the Food and Drug Administration
Modernization Act of 1997 or any other
provision of law, a sponsor of a drug that is
the subject of an application described in
subparagraph (B)(i) may elect to be eligible
for, with respect to the drug--
(i)(I) the 3-year exclusivity period
referred to under clauses (iii) and
(iv) of subsection (c)(3)(E) and under
clauses (iii) and (iv) of subsection
(j)(5)(F), subject to the requirements
of such clauses, as applicable; and
(II) the 5-year exclusivity period
referred to under clause (ii) of
subsection (c)(3)(E) and under clause
(ii) of subsection (j)(5)(F), subject
to the requirements of such clauses, as
applicable; or
(ii) a patent term extension under
section 156 of title 35, United States
Code, subject to the requirements of
such section.
(B) Application; antibiotic drug described.--
(i) Application.--An application
described in this clause is an
application for marketing submitted
under this section after the date of
the enactment of this subsection in
which the drug that is the subject of
the application contains an antibiotic
drug described in clause (ii).
(ii) Antibiotic drug.--An antibiotic
drug described in this clause is an
antibiotic drug that was the subject of
1 or more applications received by the
Secretary under section 507 of this Act
(as in effect before November 21,
1997), none of which was approved by
the Secretary under such section.
(3) Limitations.--
(A) Exclusivities and extensions.--Paragraphs
(1)(A) and (2)(A) shall not be construed to
entitle a drug that is the subject of an
approved application described in subparagraphs
(1)(B)(i) or (2)(B)(i), as applicable, to any
market exclusivities or patent extensions other
than those exclusivities or extensions
described in paragraph (1)(A) or (2)(A).
(B) Conditions of use.--Paragraphs (1)(A) and
(2)(A)(i) shall not apply to any condition of
use for which the drug referred to in
subparagraph (1)(B)(i) or (2)(B)(i), as
applicable, was approved before the date of the
enactment of this subsection.
(4) Application of certain provisions.--
Notwithstanding section 125, or any other provision, of
the Food and Drug Administration Modernization Act of
1997, or any other provision of law, and subject to the
limitations in paragraphs (1), (2), and (3), the
provisions of the Drug Price Competition and Patent
Term Restoration Act of 1984 shall apply to any drug
subject to paragraph (1) or any drug with respect to
which an election is made under paragraph (2)(A).
(w) Deadline for Determination on Certain Petitions.--The
Secretary shall issue a final, substantive determination on a
petition submitted pursuant to subsection (b) of section
314.161 of title 21, Code of Federal Regulations (or any
successor regulations), no later than 270 days after the date
the petition is submitted.
(x) Date of Approval in the Case of Recommended Controls
Under the CSA.--
(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the
Secretary provides notice to the sponsor that the
Secretary intends to issue a scientific and medical
evaluation and recommend controls under the Controlled
Substances Act, approval of such application shall not
take effect until the interim final rule controlling
the drug is issued in accordance with section 201(j) of
the Controlled Substances Act.
(2) Date of approval.--For purposes of this section,
with respect to an application described in paragraph
(1), the term ``date of approval'' shall mean the later
of--
(A) the date an application under subsection
(b) is approved under subsection (c); or
(B) the date of issuance of the interim final
rule controlling the drug.
(y) Contrast Agents Intended for Use With Applicable Medical
Imaging Devices.--
(1) In general.--The sponsor of a contrast agent for
which an application has been approved under this
section may submit a supplement to the application
seeking approval for a new use following the
authorization of a premarket submission for an
applicable medical imaging device for that use with the
contrast agent pursuant to section 520(p)(1).
(2) Review of supplement.--In reviewing a supplement
submitted under this subsection, the agency center
charged with the premarket review of drugs may--
(A) consult with the center charged with the
premarket review of devices; and
(B) review information and data submitted to
the Secretary by the sponsor of an applicable
medical imaging device pursuant to section 515,
510(k), or 513(f)(2) so long as the sponsor of
such applicable medical imaging device has
provided to the sponsor of the contrast agent a
right of reference.
(3) Definitions.--For purposes of this subsection--
(A) the term ``new use'' means a use of a
contrast agent that is described in the
approved labeling of an applicable medical
imaging device described in section 520(p), but
that is not described in the approved labeling
of the contrast agent; and
(B) the terms ``applicable medical imaging
device'' and ``contrast agent'' have the
meanings given such terms in section 520(p).
* * * * * * *
[all]