I 
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 subse-
quent 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 appli-
cation 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 pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives 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— 
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(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 appli-
cation 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 ap-
proval by meeting all the approval requirements 
of this subsection, such applicant may not re-
ceive 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 sub-
clause: 
‘‘(III) APPLICANT
APPROVAL.—The Sec-
retary 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- 
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day exclusivity period described in subclause 
(II)(aa), if each of the following conditions is 
met: 
‘‘(aa) The approval of such applica-
tion could be made effective, but for the 
eligibility of a first applicant for 180-day 
exclusivity under this clause. 
‘‘(bb) The applicant of such applica-
tion 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 mar-
ket the drug. 
‘‘(cc) At least 33 months have passed 
since the date of submission of an applica-
tion for the drug by at least one first ap-
plicant. 
‘‘(dd) Approval of an application for 
the drug submitted by at least one first ap-
plicant is not precluded under clause (iii). 
‘‘(ee) No application for the drug sub-
mitted by any first applicant is effectively 
approved on the date that the conditions 
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under items (aa), (bb), (cc), and (dd) are 
all met and maintained.’’. 
(b) SPECIAL FORFEITURE RULE FOR CERTAIN SUB-
SEQUENT APPLICANTS.—Section 505(j)(5)(D) of the Fed-
eral 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 applica-
tion that is approved pursuant to sub-
clause (III) of subparagraph (B)(iv) is 
deemed to be tentatively approved and 
to no longer have an effective ap-
proval 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 com-
mercial marketing as required under 
such item. 
‘‘(II) OPPORTUNITY TO CURE.— 
‘‘(aa) IN GENERAL.—If the 
applicant of an application ap-
proved pursuant to subclause 
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(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
AP-
PROVAL.—If an applicant de-
scribed 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 appli-
cant submits a certification to its 
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abbreviated new drug application 
that— 
‘‘(AA) an event that 
could not have been reason-
ably foreseen by the appli-
cant prevented it from com-
mencing commercial mar-
keting; and 
‘‘(BB) it has fully re-
solved any issues preventing 
such commercial marketing 
from commencing as a result 
of such event. 
‘‘(cc) TIMING FOR SUBMIS-
SION.—An applicant described in 
item (aa) shall, not later than 
one business day after com-
mencing marketing of the drug 
that is the subject of the applica-
tion described in such item, sub-
mit a notification to the abbre-
viated new drug application con-
firming that such applicant has 
commenced 
commercial 
mar-
keting of the drug.’’. 
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(c) APPLICABILITY.—The amendments made by sub-
sections (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. 
Æ 
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