[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1114 Reported in Senate (RS)]
<DOC>
Calendar No. 108
118th CONGRESS
1st Session
S. 1114
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
180-day exclusivity period.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 30, 2023
Ms. Smith (for herself and Mr. Braun) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
June 22, 2023
Reported by Mr. Sanders, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
180-day exclusivity period.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Expanding Access to Low-
Cost Generics Act of 2023''.</DELETED>
<DELETED>SEC. 2. 180-DAY EXCLUSIVITY PERIOD.</DELETED>
<DELETED> (a) In General.--Section 505(j)(5)(B)(iv) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended--
</DELETED>
<DELETED> (1) in subclause (I)--</DELETED>
<DELETED> (A) by inserting ``and subclause (III)''
after ``subparagraph (D)''; and</DELETED>
<DELETED> (B) by inserting before the period at the
end the following: ``or an applicant whose application
was approved pursuant to subclause (III). If an
applicant described in subclause (III) is eligible for
effective approval on the same day a tentatively
approved first applicant who has requested final
approval is determined by the Secretary to be eligible
for effective approval by meeting all the approval
requirements of this subsection, such applicant
described in subclause (III) may not receive effective
approval until 180 days after the first applicant
begins commercial marketing of the drug.'';
and</DELETED>
<DELETED> (2) by adding at the end the following new
subclause:</DELETED>
<DELETED> ``(III) Applicant approval.--The Secretary
may approve an application containing a certification
described in paragraph (2)(A)(vii)(IV) that is for a
drug for which a first applicant has submitted an
application containing such a certification,
notwithstanding the eligibility of a first applicant
for the 180-day exclusivity period described in
subclause (II)(aa), if each of the following conditions
is met:</DELETED>
<DELETED> ``(aa) The approval of such
application could be made effective, but for
the eligibility of a first applicant for 180-
day exclusivity under this clause.</DELETED>
<DELETED> ``(bb) The applicant of such
application has submitted a certification to
the abbreviated new drug application that there
are no conditions that would prevent the
applicant from commercial marketing within 75
days after the date of approval and that the
applicant intends to so market the
drug.</DELETED>
<DELETED> ``(cc) At least 33 months have
passed since the date of submission of an
application for the drug by at least one first
applicant.</DELETED>
<DELETED> ``(dd) Approval of an application
for the drug submitted by at least one first
applicant is not precluded under clause
(iii).</DELETED>
<DELETED> ``(ee) No application for the drug
submitted by any first applicant is effectively
approved on the date that the conditions under
items (aa), (bb), (cc), and (dd) are all met
and maintained.''.</DELETED>
<DELETED> (b) Special Approval Status Rule for Certain Subsequent
Applicants.--Section 505(j)(5)(D) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355 (j)(5)(D)) is amended at the end by adding
the following:</DELETED>
<DELETED> ``(v) Special approval status rule for
certain subsequent applicants.--An application that is
approved pursuant to subclause (III) of subparagraph
(B)(iv) is deemed to be tentatively approved and to no
longer have an effective approval pursuant to such
subclause (III) on the date that is 76 days after the
date on which the approval has been made effective
pursuant to such subclause (III) if the applicant fails
to commercially market such drug within the 75-day
period after the date on which the approval is made
effective. If the applicant of an application approved
pursuant to such subclause (III) submits a notification
that it can no longer commence commercial marketing
within 75 days after the date of approval, as required
under subparagraph (B)(iv)(III)(bb), its application is
deemed to be tentatively approved and to no longer be
effectively approved on the date that such a
notification is received. If an applicant does not
commence commercial marketing within the 75-day period,
it shall not be eligible for a subsequent effective
approval for the application under subclause (III) of
subparagraph (B)(iv) unless, in addition to meeting
each of the conditions in such subclause (III), it
submits a certification to its abbreviated new drug
application that an event that could not have been
reasonably foreseen by the applicant prevented it from
commencing commercial marketing and that it has fully
resolved this issue. The applicant shall submit
notification to the abbreviated new drug application
confirming that such applicant has commenced commercial
marketing of the drug not later than one business day
after commencing such marketing.''.</DELETED>
<DELETED> (c) Applicability.--The amendments made by subsections (a)
and (b) shall apply only with respect to an application filed under
section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) after the date of enactment of this Act that identifies a
listed drug for which no certification under paragraph (2)(A)(vii)(IV)
of such section 505(j) was made before such date of
enactment.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Expanding Access to Low-Cost
Generics Act of 2023''.
SEC. 2. 180-DAY EXCLUSIVITY PERIOD.
(a) In General.--Section 505(j)(5)(B)(iv) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amended--
(1) in subclause (I)--
(A) by inserting ``and subclause (III)'' after
``subparagraph (D)''; and
(B) by inserting before the period at the end the
following: ``or an applicant whose application was
approved pursuant to subclause (III). If an applicant
described in subclause (III) is eligible for effective
approval on the same day a tentatively approved first
applicant who has requested final approval is
determined by the Secretary to be eligible for
effective approval by meeting all the approval
requirements of this subsection, such applicant
described in subclause (III) shall not receive
effective approval until 180 days after the first
applicant begins commercial marketing of the drug.'';
and
(2) by adding at the end the following new subclause:
``(III) Applicant approval.--The Secretary may
approve an application containing a certification
described in paragraph (2)(A)(vii)(IV) that is for a
drug for which a first applicant has submitted an
application containing such a certification,
notwithstanding the eligibility of a first applicant
for the 180-day exclusivity period described in
subclause (II)(aa), if each of the following conditions
is met:
``(aa) The approval of such application could be
made effective, but for the eligibility of a first
applicant for 180-day exclusivity under this clause.
``(bb) The applicant of such application has
submitted a certification to its abbreviated new drug
application that there are no conditions that would
prevent the applicant from commercial marketing within
75 days after the date of approval and that the
applicant intends to so market the drug.
``(cc) At least 33 months have passed since the
date of submission of an application for the drug by at
least one first applicant.
``(dd) Approval of an application for the drug
submitted by at least one first applicant is not
precluded under clause (iii).
``(ee) No application for the drug submitted by any
first applicant is effectively approved on the date
that the conditions under items (aa), (bb), (cc), and
(dd) are all met and maintained.''.
(b) Special Approval Status Rule for Certain Subsequent
Applicants.--Section 505(j)(5)(D) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(5)(D)) is amended at the end by adding
the following:
``(v) Special approval status rule for
certain subsequent applicants.--An application
that is approved pursuant to subclause (III) of
subparagraph (B)(iv) is deemed to be
tentatively approved and to no longer have an
effective approval pursuant to such subclause
(III) on the date that is 76 days after the
date on which the approval has been made
effective pursuant to such subclause (III) if
the applicant fails to commercially market such
drug within the 75-day period after the date on
which the approval is made effective. If the
applicant of an application approved pursuant
to such subclause (III) submits a notification
that it can no longer commence commercial
marketing within 75 days after the date of
approval, as required under subparagraph
(B)(iv)(III)(bb), its application is deemed to
be tentatively approved and to no longer be
effectively approved on the date that such a
notification is received. If an applicant does
not commence commercial marketing within the
75-day period, it shall not be eligible for a
subsequent effective approval for the
application under subclause (III) of
subparagraph (B)(iv) unless, in addition to
meeting each of the conditions in such
subclause (III), it submits a certification to
its abbreviated new drug application that an
event that could not have been reasonably
foreseen by the applicant prevented it from
commencing commercial marketing and that it has
fully resolved this issue. The applicant shall
submit notification to the abbreviated new drug
application confirming that such applicant has
commenced commercial marketing of the drug not
later than one business day after commencing
such marketing.''.
(c) Applicability.--The amendments made by subsections (a) and (b)
shall apply only with respect to an application filed under section
505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
after the date of enactment of this Act that identifies a listed drug
for which no certification under paragraph (2)(A)(vii)(IV) of such
section 505(j) was made before such date of enactment.
SEC. 3. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.
(a) In General.--Section 505(j)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the
following:
``(H)(i) Upon request (in controlled correspondence or an analogous
process) by a person that has submitted or intends to submit an
abbreviated application under this subsection for a drug that is
required by regulation to contain one or more of the same inactive
ingredients in the same concentration as the listed drug referred to,
or for which the Secretary determines there is a scientific
justification for an approach that is in vitro, in whole or in part, to
be used to demonstrate bioequivalence for a drug if such a drug
contains one or more of the same inactive ingredients in the same
concentration as the listed drug referred to, or on the Secretary's own
initiative during the review of an application under this subsection
for such a drug, the Secretary shall inform the person whether such
drug is qualitatively and quantitatively the same as the listed drug.
``(ii) Notwithstanding section 301(j), if the Secretary determines
that such drug is not qualitatively or quantitatively the same as the
listed drug, the Secretary shall identify and disclose to the person--
``(I) the ingredient or ingredients that cause the drug not
to be qualitatively or quantitatively the same as the listed
drug; and
``(II) for any ingredient for which there is an identified
quantitative deviation, the amount of such deviation.
``(iii) If the Secretary determines that such drug is qualitatively
and quantitatively the same as the listed drug, the Secretary shall not
change or rescind such determination after the submission of an
abbreviated application for such drug under this subsection unless--
``(I) the formulation of the listed drug has been changed
and the Secretary has determined that the prior listed drug
formulation was withdrawn for reasons of safety or
effectiveness; or
``(II) the Secretary makes a written determination that the
prior determination must be changed because an error has been
identified.
``(iv) If the Secretary makes a written determination described in
clause (iii)(II), the Secretary shall provide notice and a copy of the
written determination to the person making the request under clause
(i).
``(v) Except as set forth in clauses (i) and (ii), nothing in this
subparagraph shall be construed to authorize the disclosure of
nonpublic qualitative or quantitative information about the ingredients
in a listed drug, or to affect the status, if any, of such information
as trade secret or confidential commercial information for purposes of
section 301(j) of this Act, section 552 of title 5, United States Code,
or section 1905 of title 18, United States Code.''.
(b) Guidance.--
(1) In general.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue draft guidance, or update guidance,
describing how the Secretary will determine whether a drug is
qualitatively and quantitatively the same as the listed drug
(as such terms are used in section 505(j)(3)(H) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a)),
including with respect to assessing pH adjusters.
(2) Process.--In issuing guidance under this subsection,
the Secretary of Health and Human Services shall--
(A) publish draft guidance;
(B) provide a period of at least 60 days for
comment on the draft guidance; and
(C) after considering any comments received and not
later than one year after the close of the comment
period on the draft guidance, publish final guidance.
(c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies beginning on the
date of enactment of this Act, irrespective of the date on which the
guidance required by subsection (b) is finalized.
Calendar No. 108
118th CONGRESS
1st Session
S. 1114
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
180-day exclusivity period.
_______________________________________________________________________
June 22, 2023
Reported with an amendment