[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1114 Introduced in Senate (IS)]
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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
_______________________________________________________________________
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,
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) may 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 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.
``(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.
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