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116th Congress } { Report
HOUSE OF REPRESENTATIVES
1st Session } { 116-48
======================================================================
PURPLE BOOK CONTINUITY ACT OF 2019
_______
May 3, 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. 1520]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 1520) to amend the Public Health Service Act to
provide for the publication of a list of licensed biological
products, and for other purposes, having considered the same,
report favorably thereon with an amendment and recommend that
the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 3
Background and Need for the Legislation.......................... 3
Committee Hearings............................................... 3
Committee Consideration.......................................... 4
Committee Votes.................................................. 4
Oversight Findings............................................... 4
New Budget Authority, Entitlement Authority, and Tax Expenditures 4
Congressional Budget Office Estimate............................. 5
Federal Mandates Statement....................................... 6
Statement of General Performance Goals and Objectives............ 6
Duplication of Federal Programs.................................. 7
Committee Cost Estimate.......................................... 7
Earmarks, Limited Tax Benefits, and Limited Tariff Benefits...... 7
Advisory Committee Statement..................................... 7
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Purple Book Continuity Act of 2019''.
SEC. 2. PUBLIC LISTING.
Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) is
amended by adding at the end the following:
``(9) Public listing.--
``(A) In general.--
``(i) Initial publication.--Not later than
180 days after the date of enactment of the
Purple Book Continuity Act of 2019, the
Secretary shall publish and make available to
the public in a searchable, electronic format--
``(I) a list in alphabetical order of
the nonproprietary or proper name of
each biological product for which a
biologics license under subsection (a)
or this subsection is in effect, or
that has been deemed to be licensed
under this section pursuant to section
7002(e)(4) of the Biologics Price
Competition and Innovation Act of 2009,
as of such date of enactment;
``(II) the date of approval of the
marketing application and the
application number; and
``(III) the marketing or licensure
status of the biological product for
which a biologics license under
subsection (a) or this subsection is in
effect or that has been deemed to be
licensed under this section pursuant to
section 7002(e)(4) of the Biologics
Price Competition and Innovation Act of
2009.
``(ii) Revisions.--Every 30 days after the
publication of the first list under clause (i),
the Secretary shall revise the list to include
each biological product which has been licensed
under subsection (a) or this subsection during
the 30-day period.
``(iii) Patent information.--Not later than
30 days after a list of patents under
subsection (l)(3)(A), or a supplement to such
list under subsection (l)(7), has been provided
by the reference product sponsor to the
subsection (k) applicant respecting a
biological product included on the list
published under this subparagraph, the
reference product sponsor shall provide such
list of patents (or supplement thereto) and
their corresponding expiry dates to the
Secretary, and the Secretary shall, in
revisions made under clause (ii), include such
information for such biological product. Within
30 days of providing any subsequent or
supplemental list of patents to any subsequent
subsection (k) applicant under subsection
(l)(3)(A) or (l)(7), the reference product
sponsor shall update the information provided
to the Secretary under this clause with any
additional patents from such subsequent or
supplemental list and their corresponding
expiry dates.
``(iv) Listing of exclusivities.--For each
biological product included on the list
published under this subparagraph, the
Secretary shall specify each exclusivity period
that is applicable and has not concluded under
paragraph (6) or paragraph (7).
``(B) Withdrawal or suspension of licensure.--If the
licensing of a biological product was withdrawn or
suspended for safety, purity, or potency reasons, it
may not be published in the list under subparagraph
(A). If the withdrawal or suspension occurred after its
publication in such list, the reference product sponsor
shall notify the Secretary that--
``(i) the biological product shall be
immediately removed from such list--
``(I) for the same period as the
withdrawal or suspension; or
``(II) if the biological product 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,
purity, or potency reasons; and
``(ii) a notice of the removal shall be
published in the Federal Register.''.
SEC. 3. REVIEW AND REPORT ON TYPES OF INFORMATION TO BE LISTED.
Not later than 3 years after the date of enactment of this Act, the
Secretary of Health and Human Services shall--
(1) solicit public comment regarding the type of information,
if any, that should be added to or removed from the list
required by paragraph (9) of section 351(k) of the Public
Health Service Act (42 U.S.C. 262(k)), as added by section 2;
and
(2) transmit to Congress an evaluation of such comments,
including any recommendations about the types of information
that should be added to or removed from the list.
Purpose and Summary
H.R. 1520, the ``Purple Book Continuity Act of 2019'' was
introduced on March 5, 2019, by Rep. Anna G. Eshoo (D-CA) and
referred to the Committee on Energy and Commerce. H.R. 1520
amends the Public Health Service Act (PHS Act) to codify
publication of approved biological products in the Purple Book
in a searchable, electronic format, specify that the Purple
Book should be published electronically on the website of the
Food and Drug Administration (FDA) and updated routinely, list
relevant patents and exclusivities for biological products, and
direct the FDA to consider the types of patents that should be
listed in the Purple Book.
Background and Need for Legislation
In September 2014, the FDA published the first edition of
the ``Purple Book.'' Similar to the ``Orange Book,'' which
lists patents and exclusivities for small molecule drug
products, the ``Purple Book'' lists biological products,
including biosimilar and interchangeable biological products,
that have been licensed by FDA under the PHS Act. The current
``Purple Book'' also includes the date the biological product
was licensed and whether FDA evaluated the product for
reference product exclusivity under section 351(k)(7) of the
PHS Act. Publication of this list is not a statutory
requirement and is currently published as a static document.
Stakeholders, such as prescribers, pharmacists, and
manufacturers, utilize the ``Purple Book'' as a reference for
product information and for development purposes. Some
stakeholders have recommended that the ``Purple Book'' be
improved to make it more functional, including making such
information available in a searchable, electronic format, as
well as to provide information regarding relevant exclusivities
and to have such information updated more routinely.
H.R. 1520 would codify publication of the ``Purple Book,''
outline specific requirements for the information that should
be included in such publication, and directs FDA to solicit
feedback about what further information should be included in
the ``Purple Book.''
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. 1520:
The Subcommittee on Health held a legislative hearing
entitled ``Lowing the Cost of Prescription Drugs: Reducing
Barriers to Market Competition'' on March 13, 2019. The hearing
considered H.R. 1520, the ``Purple Book Continuity Act of
2019'', 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. 1520, the ``Purple Book Continuity Act of 2019'', was
introduced on March 5, 2019, by Rep. Eshoo (D-CA), and referred
to the Committee on Energy and Commerce. The bill was
subsequently referred to the Subcommittee on Health on March 6,
2019. Following legislative hearings, the Subcommittee met in
open markup session on H.R. 1520, pursuant to notice, on March
27, 2019, for consideration of the bill. A manager's amendment
offered by Ms. Eshoo was adopted by a voice vote. Subsequently,
the Subcommittee on Health agreed to a motion by Ms. Eshoo,
Chairwoman of the Subcommittee, to favorably forward H.R. 1520
to the full Committee on Energy and Commerce, amended, by a
voice vote.
The Committee on Energy and Commerce met in open markup
session, pursuant to notice, on April 3, 2019, to consider H.R.
1520, as amended by the subcommittee. A bipartisan manager's
amendment, offered by Ms. Eshoo and supported by Mr. Burgess,
was adopted by a voice vote. At the conclusion of consideration
and markup of the bill, the Committee agreed to a motion by Mr.
Pallone, Chairman of the Committee, to order H.R. 1520
favorably reported to the House, amended, 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.
1520 during Committee markup. A motion by Mr. Pallone to order
H.R. 1520 favorably reported to the House, amended, 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.
1520 from the Director of the Congressional Budget Office:
U.S. Congress,
Congressional Budget Office,
Washington, DC, May 3, 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. 1520, the Purple
Book Continuity Act of 2019.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Julia
Christensen.
Sincerely,
Keith Hall,
Director.
Enclosure.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Under current law, the Food and Drug Administration (FDA)
publishes a reference guide for biological products, Lists of
Licensed Biological Products with Reference Product Exclusivity
and Biosimilarity or Interchangeability Evaluations, commonly
known as the ``Purple Book.'' H.R. 1520 would codify
publication of the Purple Book by FDA, require that the agency
include more detailed information in the compendium, make the
data available in a searchable electronic format, and update it
every 30 days.
The Purple Book currently specifies whether a biological
product licensed and marketed under section 351(k) of the
Public Health Service Act (PHS) has been determined by FDA to
be biosimilar to (or interchangeable with) the reference
biological product. The Purple Book also includes the date a
biological product was licensed for marketing under 351(a) of
the PHS Act and whether FDA evaluated the biological product
for reference product exclusivity. Information contained in the
Purple Book is useful to health care practitioners and
developers of biosimilar or interchangeable products and is
updated periodically by FDA.
H.R. 1520 would require that the FDA proactively determine
the reference product exclusivity for each licensed biological
product listed in the Purple Book. The determination of
reference product exclusivity is a complex, resource intensive
assessment for the agency to make; thus, under current law it
is generally made either for reasons of regulatory necessity or
because the license holder that submitted the application
requested the determination. The bill also would direct FDA to
solicit public comments regarding the type of information that
should be contained in the Purple Book and transmit a report to
the Congress within three years after the date of enactment.
Based on the cost of similar activities, CBO expects that
the FDA would require the equivalent of about 5 full-time
employees in 2020 to cover the increased workload to comply
with the listing and reporting requirements at cost of about
$300,000 per employee. CBO expects that fewer employees would
be needed in later years and that by 2023, ongoing personnel-
related expenses to fulfill the bill's requirements would total
less than $500,000 annually. CBO estimates that implementing
the bill would cost FDA about $3 million over the 2020-2024
period. Such spending would be subject to the availability of
appropriated funds.
H.R. 1520 would impose a private-sector mandate as defined
in the Unfunded Mandates Reform Act (UMRA) by requiring
biological product manufacturers to provide the FDA with
certain patent information when that information is shared with
biosimilar product manufacturers. CBO estimates the cost of the
mandate would fall well below the private-sector threshold
established in UMRA ($164 million in 2019, adjusted annually
for inflation).
The CBO staff contacts for this estimate are Julia
Christensen (for federal costs) and Andrew Laughlin (for
mandates). 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 PHS Act to provide for the publication of a list of
licensed biological products and the patents and exclusivities
related to such products, and to direct FDA to solicit public
comment regarding the types of information that should be added
or removed from the ``Purple Book'' and to transmit to Congress
an evaluation of such comments.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 1520 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. 1520 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 this Act may be cited as the
``Purple Book Continuity Act of 2019''.
Section 2. Public listing
Section 2 amends Section 351(k) of the PHS Act (42 U.S.C.
262(k)) to require the FDA to publish electronically within 180
days of enactment: a list of the nonproprietary or proper name
of each biological product for which a biologics license is in
effect or that has been deemed to be licensed; the date of
approval of the marketing application and the application
number; and the marketing or licensure status of the biological
product for which a biologics license is in effect or that has
been deemed to be licensed.
This section also requires the Secretary of Health and
Human Services (the Secretary) to update the list every 30 days
to include each new biological product that has been licensed
during the previous 30-day period. The Secretary is required to
include patent information provided by the reference product
sponsor on the list no later than 30 days after a list of
patents under subsection (l)(3)(A) of the PHS Act is provided
to the subsection (k) applicant respecting a biological product
on the list. In addition, the Secretary shall include on the
list any applicable exclusivity periods for each biological
product that has not concluded.
This section also specifies that any biological product
that has had its licensing withdrawn or suspended for safety,
purity, or potency reasons must be removed from the book. If
the withdrawal or suspension of the license occurred after
publication in the list, the reference product sponsor is
required to notify the Secretary that: the biological product
shall be immediately removed from the list for the same period
as the withdrawal or suspension, or withdrawal of sale period;
and a notice of removal will be published in the Federal
Register.
Section 3. Review and report on types of biological products patents to
be listed
Section 3 requires the Secretary to solicit public comment
regarding the types of information that should be included in
or removed from the list no later than 3 years after the date
of enactment of this Act and requires an evaluation of such
comments and any recommendations be transmitted to Congress.
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 (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
* * * * * * *
Part F--Licensing--Biological Products and Clinical Laboratories
Subpart 1--Biological Products
regulation of biological products
Sec. 351. (a)(1) No person shall introduce or deliver for
introduction into interstate commerce any biological product
unless--
(A) a biologics license under this subsection or
subsection (k) is in effect for the biological product;
and
(B) each package of the biological product is plainly
marked with--
(i) the proper name of the biological product
contained in the package;
(ii) the name, address, and applicable
license number of the manufacturer of the
biological product; and
(iii) the expiration date of the biological
product.
(2)(A) The Secretary shall establish, by regulation,
requirements for the approval, suspension, and revocation of
biologics licenses.
(B) Pediatric studies.--A person that submits an
application for a license under this paragraph shall
submit to the Secretary as part of the application any
assessments required under section 505B of the Federal
Food, Drug, and Cosmetic Act.
(C) The Secretary shall approve a biologics license
application--
(i) on the basis of a demonstration that--
(I) the biological product that is the
subject of the application is safe, pure, and
potent; and
(II) the facility in which the biological
product is manufactured, processed, packed, or
held meets standards designed to assure that
the biological product continues to be safe,
pure, and potent; and
(ii) if the applicant (or other appropriate person)
consents to the inspection of the facility that is the
subject of the application, in accordance with
subsection (c).
(D) Postmarket Studies and Clinical Trials; Labeling; Risk
Evaluation and Mitigation Strategy.--A person that submits an
application for a license under this paragraph is subject to
sections 505(o), 505(p), and 505-1 of the Federal Food, Drug,
and Cosmetic Act.
(E)(i) 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
this subsection, if such supplemental application complies with
the requirements of subparagraph (B) of section 505(c)(5) of
the Federal Food, Drug, and Cosmetic Act.
(ii) In this subparagraph, the terms ``qualified indication''
and ``qualified data summary'' have the meanings given such
terms in section 505(c)(5) of the Federal Food, Drug, and
Cosmetic Act.
(3) The Secretary shall prescribe requirements under which a
biological product undergoing investigation shall be exempt
from the requirements of paragraph (1).
(b) No person shall falsely label or mark any package or
container of any biological product or alter any label or mark
on the package or container of the biological product so as to
falsify the label or mark.
(c) Any officer, agent, or employee of the Department of
Health and Human Services, authorized by the Secretary for the
purpose, may during all reasonable hours enter and inspect any
establishment for the propagation or manufacture and
preparation of any biological product.
(d)(1) Upon a determination that a batch, lot, or other
quantity of a product licensed under this section presents an
imminent or substantial hazard to the public health, the
Secretary shall issue an order immediately ordering the recall
of such batch, lot, or other quantity of such product. An order
under this paragraph shall be issued in accordance with section
554 of title 5, United States Code.
(2) Any violation of paragraph (1) shall subject the violator
to a civil penalty of up to $100,000 per day of violation. The
amount of a civil penalty under this paragraph shall, effective
December 1 of each year beginning 1 year after the effective
date of this paragraph, be increased by the percent change in
the Consumer Price Index for the base quarter of such year over
the Consumer Price Index for the base quarter of the preceding
year, adjusted to the nearest \1/10\ of 1 percent. For purposes
of this paragraph, the term ``base quarter'', as used with
respect to a year, means the calendar quarter ending on
September 30 of such year and the price index for a base
quarter is the arithmetical mean of such index for the 3 months
comprising such quarter.
(e) No person shall interfere with any officer, agent, or
employee of the Service in the performance of any duty imposed
upon him by this section or by regulations made by authority
thereof.
(f) Any person who shall violate, or aid or abet in
violating, any of the provisions of this section shall be
punished upon conviction by a fine not exceeding $500 or by
imprisonment not exceeding one year, or by both such fine and
imprisonment, in the discretion of the court.
(g) Nothing contained in this Act shall be construed as in
any way affecting, modifying, repealing, or superseding the
provisions of the Federal Food, Drug, and Cosmetic Act (U.S.C.,
1940 edition, title 21, ch. 9).
(h) A partially processed biological product which--
(1) is not in a form applicable to the prevention,
treatment, or cure of diseases or injuries of man;
(2) is not intended for sale in the United States;
and
(3) is intended for further manufacture into final
dosage form outside the United States,
shall be subject to no restriction on the export of the product
under this Act or the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et. seq.) if the product is manufactured, processed,
packaged, and held in conformity with current good
manufacturing practice requirements or meets international
manufacturing standards as certified by an international
standards organization recognized by the Secretary and meets
the requirements of section 801(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(e)).
(i) In this section:
(1) The term ``biological product'' means a virus,
therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic product,
protein (except any chemically synthesized
polypeptide), or analogous product, or arsphenamine or
derivative of arsphenamine (or any other trivalent
organic arsenic compound), applicable to the
prevention, treatment, or cure of a disease or
condition of human beings.
(2) The term ``biosimilar'' or ``biosimilarity'', in
reference to a biological product that is the subject
of an application under subsection (k), means--
(A) that the biological product is highly
similar to the reference product
notwithstanding minor differences in clinically
inactive components; and
(B) there are no clinically meaningful
differences between the biological product and
the reference product in terms of the safety,
purity, and potency of the product.
(3) The term ``interchangeable'' or
``interchangeability'', in reference to a biological
product that is shown to meet the standards described
in subsection (k)(4), means that the biological product
may be substituted for the reference product without
the intervention of the health care provider who
prescribed the reference product.
(4) The term ``reference product'' means the single
biological product licensed under subsection (a)
against which a biological product is evaluated in an
application submitted under subsection (k).
(j) The Federal Food, Drug, and Cosmetic Act, including the
requirements under sections 505(o), 505(p), and 505-1 of such
Act, applies to a biological product subject to regulation
under this section, except that a product for which a license
has been approved under subsection (a) shall not be required to
have an approved application under section 505 of such Act.
(k) Licensure of Biological Products as Biosimilar or
Interchangeable.--
(1) In general.--Any person may submit an application
for licensure of a biological product under this
subsection.
(2) Content.--
(A) In general.--
(i) Required information.--An
application submitted under this
subsection shall include information
demonstrating that--
(I) the biological product is
biosimilar to a reference
product based upon data derived
from--
(aa) analytical
studies that
demonstrate that the
biological product is
highly similar to the
reference product
notwithstanding minor
differences in
clinically inactive
components;
(bb) animal studies
(including the
assessment of
toxicity); and
(cc) a clinical study
or studies (including
the assessment of
immunogenicity and
pharmacokinetics or
pharmacodynamics) that
are sufficient to
demonstrate safety,
purity, and potency in
1 or more appropriate
conditions of use for
which the reference
product is licensed and
intended to be used and
for which licensure is
sought for the
biological product;
(II) the biological product
and reference product utilize
the same mechanism or
mechanisms of action for the
condition or conditions of use
prescribed, recommended, or
suggested in the proposed
labeling, but only to the
extent the mechanism or
mechanisms of action are known
for the reference product;
(III) the condition or
conditions of use prescribed,
recommended, or suggested in
the labeling proposed for the
biological product have been
previously approved for the
reference product;
(IV) the route of
administration, the dosage
form, and the strength of the
biological product are the same
as those of the reference
product; and
(V) the facility in which the
biological product is
manufactured, processed,
packed, or held meets standards
designed to assure that the
biological product continues to
be safe, pure, and potent.
(ii) Determination by secretary.--The
Secretary may determine, in the
Secretary's discretion, that an element
described in clause (i)(I) is
unnecessary in an application submitted
under this subsection.
(iii) Additional information.--An
application submitted under this
subsection--
(I) shall include publicly-
available information regarding
the Secretary's previous
determination that the
reference product is safe,
pure, and potent; and
(II) may include any
additional information in
support of the application,
including publicly-available
information with respect to the
reference product or another
biological product.
(B) Interchangeability.--An application (or a
supplement to an application) submitted under
this subsection may include information
demonstrating that the biological product meets
the standards described in paragraph (4).
(3) Evaluation by secretary.--Upon review of an
application (or a supplement to an application)
submitted under this subsection, the Secretary shall
license the biological product under this subsection
if--
(A) the Secretary determines that the
information submitted in the application (or
the supplement) is sufficient to show that the
biological product--
(i) is biosimilar to the reference
product; or
(ii) meets the standards described in
paragraph (4), and therefore is
interchangeable with the reference
product; and
(B) the applicant (or other appropriate
person) consents to the inspection of the
facility that is the subject of the
application, in accordance with subsection (c).
(4) Safety standards for determining
interchangeability.--Upon review of an application
submitted under this subsection or any supplement to
such application, the Secretary shall determine the
biological product to be interchangeable with the
reference product if the Secretary determines that the
information submitted in the application (or a
supplement to such application) is sufficient to show
that--
(A) the biological product--
(i) is biosimilar to the reference
product; and
(ii) can be expected to produce the
same clinical result as the reference
product in any given patient; and
(B) for a biological product that is
administered more than once to an individual,
the risk in terms of safety or diminished
efficacy of alternating or switching between
use of the biological product and the reference
product is not greater than the risk of using
the reference product without such alternation
or switch.
(5) General rules.--
(A) One reference product per application.--A
biological product, in an application submitted
under this subsection, may not be evaluated
against more than 1 reference product.
(B) Review.--An application submitted under
this subsection shall be reviewed by the
division within the Food and Drug
Administration that is responsible for the
review and approval of the application under
which the reference product is licensed.
(C) Risk evaluation and mitigation
strategies.--The authority of the Secretary
with respect to risk evaluation and mitigation
strategies under the Federal Food, Drug, and
Cosmetic Act shall apply to biological products
licensed under this subsection in the same
manner as such authority applies to biological
products licensed under subsection (a).
(6) Exclusivity for first interchangeable biological
product.--Upon review of an application submitted under
this subsection relying on the same reference product
for which a prior biological product has received a
determination of interchangeability for any condition
of use, the Secretary shall not make a determination
under paragraph (4) that the second or subsequent
biological product is interchangeable for any condition
of use until the earlier of--
(A) 1 year after the first commercial
marketing of the first interchangeable
biosimilar biological product to be approved as
interchangeable for that reference product;
(B) 18 months after--
(i) a final court decision on all
patents in suit in an action instituted
under subsection (l)(6) against the
applicant that submitted the
application for the first approved
interchangeable biosimilar biological
product; or
(ii) the dismissal with or without
prejudice of an action instituted under
subsection (l)(6) against the applicant
that submitted the application for the
first approved interchangeable
biosimilar biological product; or
(C)(i) 42 months after approval of the first
interchangeable biosimilar biological product
if the applicant that submitted such
application has been sued under subsection
(l)(6) and such litigation is still ongoing
within such 42-month period; or
(ii) 18 months after approval of the first
interchangeable biosimilar biological product
if the applicant that submitted such
application has not been sued under subsection
(l)(6).
For purposes of this paragraph, the term ``final court
decision'' means a final decision of a court from which
no appeal (other than a petition to the United States
Supreme Court for a writ of certiorari) has been or can
be taken.
(7) Exclusivity for reference product.--
(A) Effective date of biosimilar application
approval.--Approval of an application under
this subsection may not be made effective by
the Secretary until the date that is 12 years
after the date on which the reference product
was first licensed under subsection (a).
(B) Filing period.--An application under this
subsection may not be submitted to the
Secretary until the date that is 4 years after
the date on which the reference product was
first licensed under subsection (a).
(C) First licensure.--Subparagraphs (A) and
(B) shall not apply to a license for or
approval of--
(i) a supplement for the biological
product that is the reference product;
or
(ii) a subsequent application filed
by the same sponsor or manufacturer of
the biological product that is the
reference product (or a licensor,
predecessor in interest, or other
related entity) for--
(I) a change (not including a
modification to the structure
of the biological product) that
results in a new indication,
route of administration, dosing
schedule, dosage form, delivery
system, delivery device, or
strength; or
(II) a modification to the
structure of the biological
product that does not result in
a change in safety, purity, or
potency.
(8) Guidance documents.--
(A) In general.--The Secretary may, after
opportunity for public comment, issue guidance
in accordance, except as provided in
subparagraph (B)(i), with section 701(h) of the
Federal Food, Drug, and Cosmetic Act with
respect to the licensure of a biological
product under this subsection. Any such
guidance may be general or specific.
(B) Public comment.--
(i) In general.--The Secretary shall
provide the public an opportunity to
comment on any proposed guidance issued
under subparagraph (A) before issuing
final guidance.
(ii) Input regarding most valuable
guidance.--The Secretary shall
establish a process through which the
public may provide the Secretary with
input regarding priorities for issuing
guidance.
(C) No requirement for application
consideration.--The issuance (or non-issuance)
of guidance under subparagraph (A) shall not
preclude the review of, or action on, an
application submitted under this subsection.
(D) Requirement for product class-specific
guidance.--If the Secretary issues product
class-specific guidance under subparagraph (A),
such guidance shall include a description of--
(i) the criteria that the Secretary
will use to determine whether a
biological product is highly similar to
a reference product in such product
class; and
(ii) the criteria, if available, that
the Secretary will use to determine
whether a biological product meets the
standards described in paragraph (4).
(E) Certain product classes.--
(i) Guidance.--The Secretary may
indicate in a guidance document that
the science and experience, as of the
date of such guidance, with respect to
a product or product class (not
including any recombinant protein) does
not allow approval of an application
for a license as provided under this
subsection for such product or product
class.
(ii) Modification or reversal.--The
Secretary may issue a subsequent
guidance document under subparagraph
(A) to modify or reverse a guidance
document under clause (i).
(iii) No effect on ability to deny
license.--Clause (i) shall not be
construed to require the Secretary to
approve a product with respect to which
the Secretary has not indicated in a
guidance document that the science and
experience, as described in clause (i),
does not allow approval of such an
application.
(9) Public listing.--
(A) In general.--
(i) Initial publication.--Not later
than 180 days after the date of
enactment of the Purple Book Continuity
Act of 2019, the Secretary shall
publish and make available to the
public in a searchable, electronic
format--
(I) a list in alphabetical
order of the nonproprietary or
proper name of each biological
product for which a biologics
license under subsection (a) or
this subsection is in effect,
or that has been deemed to be
licensed under this section
pursuant to section 7002(e)(4)
of the Biologics Price
Competition and Innovation Act
of 2009, as of such date of
enactment;
(II) the date of approval of
the marketing application and
the application number; and
(III) the marketing or
licensure status of the
biological product for which a
biologics license under
subsection (a) or this
subsection is in effect or that
has been deemed to be licensed
under this section pursuant to
section 7002(e)(4) of the
Biologics Price Competition and
Innovation Act of 2009.
(ii) Revisions.--Every 30 days after
the publication of the first list under
clause (i), the Secretary shall revise
the list to include each biological
product which has been licensed under
subsection (a) or this subsection
during the 30-day period.
(iii) Patent information.--Not later
than 30 days after a list of patents
under subsection (l)(3)(A), or a
supplement to such list under
subsection (l)(7), has been provided by
the reference product sponsor to the
subsection (k) applicant respecting a
biological product included on the list
published under this subparagraph, the
reference product sponsor shall provide
such list of patents (or supplement
thereto) and their corresponding expiry
dates to the Secretary, and the
Secretary shall, in revisions made
under clause (ii), include such
information for such biological
product. Within 30 days of providing
any subsequent or supplemental list of
patents to any subsequent subsection
(k) applicant under subsection
(l)(3)(A) or (l)(7), the reference
product sponsor shall update the
information provided to the Secretary
under this clause with any additional
patents from such subsequent or
supplemental list and their
corresponding expiry dates.
(iv) Listing of exclusivities.--For
each biological product included on the
list published under this subparagraph,
the Secretary shall specify each
exclusivity period that is applicable
and has not concluded under paragraph
(6) or paragraph (7).
(B) Withdrawal or suspension of licensure.--
If the licensing of a biological product was
withdrawn or suspended for safety, purity, or
potency reasons, it may not be published in the
list under subparagraph (A). If the withdrawal
or suspension occurred after its publication in
such list, the reference product sponsor shall
notify the Secretary that--
(i) the biological product shall be
immediately removed from such list--
(I) for the same period as
the withdrawal or suspension;
or
(II) if the biological
product 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,
purity, or potency reasons; and
(ii) a notice of the removal shall be
published in the Federal Register.
(l) Patents.--
(1) Confidential access to subsection (k)
application.--
(A) Application of paragraph.--Unless
otherwise agreed to by a person that submits an
application under subsection (k) (referred to
in this subsection as the ``subsection (k)
applicant'') and the sponsor of the application
for the reference product (referred to in this
subsection as the ``reference product
sponsor''), the provisions of this paragraph
shall apply to the exchange of information
described in this subsection.
(B) In general.--
(i) Provision of confidential
information.--When a subsection (k)
applicant submits an application under
subsection (k), such applicant shall
provide to the persons described in
clause (ii), subject to the terms of
this paragraph, confidential access to
the information required to be produced
pursuant to paragraph (2) and any other
information that the subsection (k)
applicant determines, in its sole
discretion, to be appropriate (referred
to in this subsection as the
``confidential information'').
(ii) Recipients of information.--The
persons described in this clause are
the following:
(I) Outside counsel.--One or
more attorneys designated by
the reference product sponsor
who are employees of an entity
other than the reference
product sponsor (referred to in
this paragraph as the ``outside
counsel''), provided that such
attorneys do not engage,
formally or informally, in
patent prosecution relevant or
related to the reference
product.
(II) In-house counsel.--One
attorney that represents the
reference product sponsor who
is an employee of the reference
product sponsor, provided that
such attorney does not engage,
formally or informally, in
patent prosecution relevant or
related to the reference
product.
(iii) Patent owner access.--A
representative of the owner of a patent
exclusively licensed to a reference
product sponsor with respect to the
reference product and who has retained
a right to assert the patent or
participate in litigation concerning
the patent may be provided the
confidential information, provided that
the representative informs the
reference product sponsor and the
subsection (k) applicant of his or her
agreement to be subject to the
confidentiality provisions set forth in
this paragraph, including those under
clause (ii).
(C) Limitation on disclosure.--No person that
receives confidential information pursuant to
subparagraph (B) shall disclose any
confidential information to any other person or
entity, including the reference product sponsor
employees, outside scientific consultants, or
other outside counsel retained by the reference
product sponsor, without the prior written
consent of the subsection (k) applicant, which
shall not be unreasonably withheld.
(D) Use of confidential information.--
Confidential information shall be used for the
sole and exclusive purpose of determining, with
respect to each patent assigned to or
exclusively licensed by the reference product
sponsor, whether a claim of patent infringement
could reasonably be asserted if the subsection
(k) applicant engaged in the manufacture, use,
offering for sale, sale, or importation into
the United States of the biological product
that is the subject of the application under
subsection (k).
(E) Ownership of confidential information.--
The confidential information disclosed under
this paragraph is, and shall remain, the
property of the subsection (k) applicant. By
providing the confidential information pursuant
to this paragraph, the subsection (k) applicant
does not provide the reference product sponsor
or the outside counsel any interest in or
license to use the confidential information,
for purposes other than those specified in
subparagraph (D).
(F) Effect of infringement action.--In the
event that the reference product sponsor files
a patent infringement suit, the use of
confidential information shall continue to be
governed by the terms of this paragraph until
such time as a court enters a protective order
regarding the information. Upon entry of such
order, the subsection (k) applicant may
redesignate confidential information in
accordance with the terms of that order. No
confidential information shall be included in
any publicly-available complaint or other
pleading. In the event that the reference
product sponsor does not file an infringement
action by the date specified in paragraph (6),
the reference product sponsor shall return or
destroy all confidential information received
under this paragraph, provided that if the
reference product sponsor opts to destroy such
information, it will confirm destruction in
writing to the subsection (k) applicant.
(G) Rule of construction.--Nothing in this
paragraph shall be construed--
(i) as an admission by the subsection
(k) applicant regarding the validity,
enforceability, or infringement of any
patent; or
(ii) as an agreement or admission by
the subsection (k) applicant with
respect to the competency, relevance,
or materiality of any confidential
information.
(H) Effect of violation.--The disclosure of
any confidential information in violation of
this paragraph shall be deemed to cause the
subsection (k) applicant to suffer irreparable
harm for which there is no adequate legal
remedy and the court shall consider immediate
injunctive relief to be an appropriate and
necessary remedy for any violation or
threatened violation of this paragraph.
(2) Subsection (k) application information.--Not
later than 20 days after the Secretary notifies the
subsection (k) applicant that the application has been
accepted for review, the subsection (k) applicant--
(A) shall provide to the reference product
sponsor a copy of the application submitted to
the Secretary under subsection (k), and such
other information that describes the process or
processes used to manufacture the biological
product that is the subject of such
application; and
(B) may provide to the reference product
sponsor additional information requested by or
on behalf of the reference product sponsor.
(3) List and description of patents.--
(A) List by reference product sponsor.--Not
later than 60 days after the receipt of the
application and information under paragraph
(2), the reference product sponsor shall
provide to the subsection (k) applicant--
(i) a list of patents for which the
reference product sponsor believes a
claim of patent infringement could
reasonably be asserted by the reference
product sponsor, or by a patent owner
that has granted an exclusive license
to the reference product sponsor with
respect to the reference product, if a
person not licensed by the reference
product sponsor engaged in the making,
using, offering to sell, selling, or
importing into the United States of the
biological product that is the subject
of the subsection (k) application; and
(ii) an identification of the patents
on such list that the reference product
sponsor would be prepared to license to
the subsection (k) applicant.
(B) List and description by subsection (k)
applicant.--Not later than 60 days after
receipt of the list under subparagraph (A), the
subsection (k) applicant--
(i) may provide to the reference
product sponsor a list of patents to
which the subsection (k) applicant
believes a claim of patent infringement
could reasonably be asserted by the
reference product sponsor if a person
not licensed by the reference product
sponsor engaged in the making, using,
offering to sell, selling, or importing
into the United States of the
biological product that is the subject
of the subsection (k) application;
(ii) shall provide to the reference
product sponsor, with respect to each
patent listed by the reference product
sponsor under subparagraph (A) or
listed by the subsection (k) applicant
under clause (i)--
(I) a detailed statement that
describes, on a claim by claim
basis, the factual and legal
basis of the opinion of the
subsection (k) applicant that
such patent is invalid,
unenforceable, or will not be
infringed by the commercial
marketing of the biological
product that is the subject of
the subsection (k) application;
or
(II) a statement that the
subsection (k) applicant does
not intend to begin commercial
marketing of the biological
product before the date that
such patent expires; and
(iii) shall provide to the reference
product sponsor a response regarding
each patent identified by the reference
product sponsor under subparagraph
(A)(ii).
(C) Description by reference product
sponsor.--Not later than 60 days after receipt
of the list and statement under subparagraph
(B), the reference product sponsor shall
provide to the subsection (k) applicant a
detailed statement that describes, with respect
to each patent described in subparagraph
(B)(ii)(I), on a claim by claim basis, the
factual and legal basis of the opinion of the
reference product sponsor that such patent will
be infringed by the commercial marketing of the
biological product that is the subject of the
subsection (k) application and a response to
the statement concerning validity and
enforceability provided under subparagraph
(B)(ii)(I).
(4) Patent resolution negotiations.--
(A) In general.--After receipt by the
subsection (k) applicant of the statement under
paragraph (3)(C), the reference product sponsor
and the subsection (k) applicant shall engage
in good faith negotiations to agree on which,
if any, patents listed under paragraph (3) by
the subsection (k) applicant or the reference
product sponsor shall be the subject of an
action for patent infringement under paragraph
(6).
(B) Failure to reach agreement.--If, within
15 days of beginning negotiations under
subparagraph (A), the subsection (k) applicant
and the reference product sponsor fail to agree
on a final and complete list of which, if any,
patents listed under paragraph (3) by the
subsection (k) applicant or the reference
product sponsor shall be the subject of an
action for patent infringement under paragraph
(6), the provisions of paragraph (5) shall
apply to the parties.
(5) Patent resolution if no agreement.--
(A) Number of patents.--The subsection (k)
applicant shall notify the reference product
sponsor of the number of patents that such
applicant will provide to the reference product
sponsor under subparagraph (B)(i)(I).
(B) Exchange of patent lists.--
(i) In general.--On a date agreed to
by the subsection (k) applicant and the
reference product sponsor, but in no
case later than 5 days after the
subsection (k) applicant notifies the
reference product sponsor under
subparagraph (A), the subsection (k)
applicant and the reference product
sponsor shall simultaneously exchange--
(I) the list of patents that
the subsection (k) applicant
believes should be the subject
of an action for patent
infringement under paragraph
(6); and
(II) the list of patents, in
accordance with clause (ii),
that the reference product
sponsor believes should be the
subject of an action for patent
infringement under paragraph
(6).
(ii) Number of patents listed by
reference product sponsor.--
(I) In general.--Subject to
subclause (II), the number of
patents listed by the reference
product sponsor under clause
(i)(II) may not exceed the
number of patents listed by the
subsection (k) applicant under
clause (i)(I).
(II) Exception.--If a
subsection (k) applicant does
not list any patent under
clause (i)(I), the reference
product sponsor may list 1
patent under clause (i)(II).
(6) Immediate patent infringement action.--
(A) Action if agreement on patent list.--If
the subsection (k) applicant and the reference
product sponsor agree on patents as described
in paragraph (4), not later than 30 days after
such agreement, the reference product sponsor
shall bring an action for patent infringement
with respect to each such patent.
(B) Action if no agreement on patent list.--
If the provisions of paragraph (5) apply to the
parties as described in paragraph (4)(B), not
later than 30 days after the exchange of lists
under paragraph (5)(B), the reference product
sponsor shall bring an action for patent
infringement with respect to each patent that
is included on such lists.
(C) Notification and publication of
complaint.--
(i) Notification to secretary.--Not
later than 30 days after a complaint is
served to a subsection (k) applicant in
an action for patent infringement
described under this paragraph, the
subsection (k) applicant shall provide
the Secretary with notice and a copy of
such complaint.
(ii) Publication by secretary.--The
Secretary shall publish in the Federal
Register notice of a complaint received
under clause (i).
(7) Newly issued or licensed patents.--In the case of
a patent that--
(A) is issued to, or exclusively licensed by,
the reference product sponsor after the date
that the reference product sponsor provided the
list to the subsection (k) applicant under
paragraph (3)(A); and
(B) the reference product sponsor reasonably
believes that, due to the issuance of such
patent, a claim of patent infringement could
reasonably be asserted by the reference product
sponsor if a person not licensed by the
reference product sponsor engaged in the
making, using, offering to sell, selling, or
importing into the United States of the
biological product that is the subject of the
subsection (k) application,
not later than 30 days after such issuance or
licensing, the reference product sponsor shall provide
to the subsection (k) applicant a supplement to the
list provided by the reference product sponsor under
paragraph (3)(A) that includes such patent, not later
than 30 days after such supplement is provided, the
subsection (k) applicant shall provide a statement to
the reference product sponsor in accordance with
paragraph (3)(B), and such patent shall be subject to
paragraph (8).
(8) Notice of commercial marketing and preliminary
injunction.--
(A) Notice of commercial marketing.--The
subsection (k) applicant shall provide notice
to the reference product sponsor not later than
180 days before the date of the first
commercial marketing of the biological product
licensed under subsection (k).
(B) Preliminary injunction.--After receiving
the notice under subparagraph (A) and before
such date of the first commercial marketing of
such biological product, the reference product
sponsor may seek a preliminary injunction
prohibiting the subsection (k) applicant from
engaging in the commercial manufacture or sale
of such biological product until the court
decides the issue of patent validity,
enforcement, and infringement with respect to
any patent that is--
(i) included in the list provided by
the reference product sponsor under
paragraph (3)(A) or in the list
provided by the subsection (k)
applicant under paragraph (3)(B); and
(ii) not included, as applicable,
on--
(I) the list of patents
described in paragraph (4); or
(II) the lists of patents
described in paragraph (5)(B).
(C) Reasonable cooperation.--If the reference
product sponsor has sought a preliminary
injunction under subparagraph (B), the
reference product sponsor and the subsection
(k) applicant shall reasonably cooperate to
expedite such further discovery as is needed in
connection with the preliminary injunction
motion.
(9) Limitation on declaratory judgment action.--
(A) Subsection (k) application provided.--If
a subsection (k) applicant provides the
application and information required under
paragraph (2)(A), neither the reference product
sponsor nor the subsection (k) applicant may,
prior to the date notice is received under
paragraph (8)(A), bring any action under
section 2201 of title 28, United States Code,
for a declaration of infringement, validity, or
enforceability of any patent that is described
in clauses (i) and (ii) of paragraph (8)(B).
(B) Subsequent failure to act by subsection
(k) applicant.--If a subsection (k) applicant
fails to complete an action required of the
subsection (k) applicant under paragraph
(3)(B)(ii), paragraph (5), paragraph (6)(C)(i),
paragraph (7), or paragraph (8)(A), the
reference product sponsor, but not the
subsection (k) applicant, may bring an action
under section 2201 of title 28, United States
Code, for a declaration of infringement,
validity, or enforceability of any patent
included in the list described in paragraph
(3)(A), including as provided under paragraph
(7).
(C) Subsection (k) application not
provided.--If a subsection (k) applicant fails
to provide the application and information
required under paragraph (2)(A), the reference
product sponsor, but not the subsection (k)
applicant, may bring an action under section
2201 of title 28, United States Code, for a
declaration of infringement, validity, or
enforceability of any patent that claims the
biological product or a use of the biological
product.
(m) Pediatric Studies.--
(1) Application of certain provisions.--The
provisions of subsections (a), (d), (e), (f), (h), (i),
(j), (k), (l), (n), and (p) of section 505A of the
Federal Food, Drug, and Cosmetic Act shall apply with
respect to the extension of a period under paragraphs
(2) and (3) to the same extent and in the same manner
as such provisions apply with respect to the extension
of a period under subsection (b) or (c) of section 505A
of the Federal Food, Drug, and Cosmetic Act.
(2) Market exclusivity for new biological products.--
If, prior to approval of an application that is
submitted under subsection (a), the Secretary
determines that information relating to the use of a
new biological product in the pediatric population may
produce health benefits in that population, the
Secretary makes a written request for pediatric studies
(which shall include a timeframe for completing such
studies), the applicant agrees to the request, such
studies are completed using appropriate formulations
for each age group for which the study is requested
within any such timeframe, and the reports thereof are
submitted and accepted in accordance with section
505A(d)(4) of the Federal Food, Drug, and Cosmetic
Act--
(A) the periods for such biological product
referred to in subsection (k)(7) are deemed to
be 4 years and 6 months rather than 4 years and
12 years and 6 months rather than 12 years; and
(B) if the biological product is designated
under section 526 for a rare disease or
condition, the period for such biological
product referred to in section 527(a) is deemed
to be 7 years and 6 months rather than 7 years.
(3) Market exclusivity for already-marketed
biological products.--If the Secretary determines that
information relating to the use of a licensed
biological product in the pediatric population may
produce health benefits in that population and makes a
written request to the holder of an approved
application under subsection (a) for pediatric studies
(which shall include a timeframe for completing such
studies), the holder agrees to the request, such
studies are completed using appropriate formulations
for each age group for which the study is requested
within any such timeframe, and the reports thereof are
submitted and accepted in accordance with section
505A(d)(4) of the Federal Food, Drug, and Cosmetic
Act--
(A) the periods for such biological product
referred to in subsection (k)(7) are deemed to
be 4 years and 6 months rather than 4 years and
12 years and 6 months rather than 12 years; and
(B) if the biological product is designated
under section 526 for a rare disease or
condition, the period for such biological
product referred to in section 527(a) is deemed
to be 7 years and 6 months rather than 7 years.
(4) Exception.--The Secretary shall not extend a
period referred to in paragraph (2)(A), (2)(B), (3)(A),
or (3)(B) if the determination under section 505A(d)(4)
is made later than 9 months prior to the expiration of
such period.
(n) Date of Approval in the Case of Recommended Controls
Under the CSA.--
(1) In general.--In the case of an application under
subsection (a) with respect to a biological product 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 biological product 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), references to the date of approval of such
application, or licensure of the product subject to
such application, shall mean the later of--
(A) the date an application is approved under
subsection (a); or
(B) the date of issuance of the interim final
rule controlling the biological product.
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