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This bill would change how the government handles approval of generic drugs when the first company in line is not ready to sell the drug. In certain cases, the FDA could approve another company’s generic drug application even if the first applicant still has a special 180-day head start, as long as the second company says it can begin marketing within 75 days and other timing rules are met. The goal is to stop a first applicant from blocking competition by getting approval but not actually putting the drug on the market.
- The FDA could approve a later generic applicant if at least 33 months have passed since the first applicant filed, the later applicant can start selling within 75 days, and no first applicant is already effectively approved.
- If the later-approved company does not begin marketing within 75 days, its approval would fall back to tentative approval and it would lose that active approval status.
- If the company realizes it cannot meet the 75-day deadline, it must notify the FDA. To get another chance later, it would need to show that an unexpected event stopped marketing and that the problem has been fully fixed.
- The bill would apply only to certain new generic drug applications filed after the law takes effect, and only for drugs where the older exclusivity certification was not already made before enactment.
Official Summaries
This bill modifies provisions related to market exclusivity for a generic drug.
Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.
The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) the applicant certifies that there are no conditions that would prevent commercial marketing of the drug within 75 days of approval and that the applicant intends to do so, (3) a first applicant's application has been pending for at least 33 months, (4) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (5) no first applicant's application has been effectively approved on the date that all such conditions are met.
If an applicant fails to begin commercially marketing their drug within 75 days of approval via the aforementioned process, the applicant's approval is deemed tentative and the applicant is no longer eligible for subsequent approvals, unless the applicant certifies that the failure was due to unforeseen issues that have since been resolved.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1051 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1051
To amend the Federal Food, Drug, and Cosmetic Act to allow for the
approval of an abbreviated new drug application submitted by a
subsequent applicant in the case of a failure by a first applicant to
commence commercial marketing within a certain period, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 6, 2025
Ms. Budzinski introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to allow for the
approval of an abbreviated new drug application submitted by a
subsequent applicant in the case of a failure by a first applicant to
commence commercial marketing within a certain period, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. 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 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 Forfeiture 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 by adding at the end the following:
``(v) Special forfeiture rule for certain
subsequent applicants.--
``(I) In general.--Except as
specified in subclause (II), 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) beginning on the day
after the end of the 75-day period
specified in item (bb) of such
subclause (III) if the applicant fails
to commence commercial marketing as
required under such item.
``(II) Opportunity to cure.--
``(aa) In general.--If the
applicant of an application
approved pursuant to subclause
(III) of subparagraph (B)(iv)
submits, pursuant to item (bb)
of such subclause, a
notification that it can no
longer commence commercial
marketing within the 75-day
period specified in such item,
such application is deemed to
be tentatively approved and to
no longer be effectively
approved beginning on the date
that such a notification is
received.
``(bb) Ineligibility for
subsequent effective
approval.--If an applicant
described in item (aa) does not
commence commercial marketing
within such 75-day period, the
applicant shall not be eligible
for a subsequent effective
approval for the application
involved under subclause (III)
of subparagraph (B)(iv) unless,
in addition to meeting each of
the conditions in such
subclause (III), the applicant
submits a certification to its
abbreviated new drug
application that--
``(AA) an event
that could not have
been reasonably
foreseen by the
applicant prevented it
from commencing
commercial marketing;
and
``(BB) it has fully
resolved any issues
preventing such
commercial marketing
from commencing as a
result of such event.
``(cc) Timing for
submission.--An applicant
described in item (aa) shall,
not later than one business day
after commencing marketing of
the drug that is the subject of
the application described in
such item, submit a
notification to the abbreviated
new drug application confirming
that such applicant has
commenced commercial marketing
of the drug.''.
(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 was made before such date of enactment.
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