I
119THCONGRESS
1
STSESSION 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
FEBRUARY6, 2025
Ms. B
UDZINSKIintroduced 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-1
tives of the United States of America in Congress assembled, 2
SECTION 1. 180-DAY EXCLUSIVITY PERIOD. 3
(a) I
NGENERAL.—Section 505(j)(5)(B)(iv) of the 4
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 5
355(j)(5)(B)(iv)) is amended— 6
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(1) in subclause (I)— 1
(A) by inserting ‘‘and subclause (III)’’ 2
after ‘‘subparagraph (D)’’; and 3
(B) by inserting before the period at the 4
end the following: ‘‘or an applicant whose appli-5
cation was approved pursuant to subclause 6
(III). If an applicant described in subclause 7
(III) is eligible for effective approval on the 8
same day a tentatively approved first applicant 9
who has requested final approval is determined 10
by the Secretary to be eligible for effective ap-11
proval by meeting all the approval requirements 12
of this subsection, such applicant may not re-13
ceive effective approval until 180 days after the 14
first applicant begins commercial marketing of 15
the drug’’; and 16
(2) by adding at the end the following new sub-17
clause: 18
‘‘(III) A
PPLICANT APPROVAL .—The Sec-19
retary may approve an application containing a 20
certification described in paragraph 21
(2)(A)(vii)(IV) that is for a drug for which a 22
first applicant has submitted an application 23
containing such a certification, notwithstanding 24
the eligibility of a first applicant for the 180- 25
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day exclusivity period described in subclause 1
(II)(aa), if each of the following conditions is 2
met: 3
‘‘(aa) The approval of such applica-4
tion could be made effective, but for the 5
eligibility of a first applicant for 180-day 6
exclusivity under this clause. 7
‘‘(bb) The applicant of such applica-8
tion has submitted a certification to the 9
abbreviated new drug application that 10
there are no conditions that would prevent 11
the applicant from commercial marketing 12
within 75 days after the date of approval 13
and that the applicant intends to so mar-14
ket the drug. 15
‘‘(cc) At least 33 months have passed 16
since the date of submission of an applica-17
tion for the drug by at least one first ap-18
plicant. 19
‘‘(dd) Approval of an application for 20
the drug submitted by at least one first ap-21
plicant is not precluded under clause (iii). 22
‘‘(ee) No application for the drug sub-23
mitted by any first applicant is effectively 24
approved on the date that the conditions 25
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under items (aa), (bb), (cc), and (dd) are 1
all met and maintained.’’. 2
(b) S
PECIALFORFEITURERULE FORCERTAINSUB-3
SEQUENTAPPLICANTS.—Section 505(j)(5)(D) of the Fed-4
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355 5
(j)(5)(D)) is amended by adding at the end the following: 6
‘‘(v) S
PECIAL FORFEITURE RULE FOR 7
CERTAIN SUBSEQUENT APPLICANTS .— 8
‘‘(I) I
N GENERAL.—Except as 9
specified in subclause (II), an applica-10
tion that is approved pursuant to sub-11
clause (III) of subparagraph (B)(iv) is 12
deemed to be tentatively approved and 13
to no longer have an effective ap-14
proval pursuant to such subclause 15
(III) beginning on the day after the 16
end of the 75-day period specified in 17
item (bb) of such subclause (III) if 18
the applicant fails to commence com-19
mercial marketing as required under 20
such item. 21
‘‘(II) O
PPORTUNITY TO CURE.— 22
‘‘(aa) I
N GENERAL.—If the 23
applicant of an application ap-24
proved pursuant to subclause 25
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(III) of subparagraph (B)(iv) 1
submits, pursuant to item (bb) of 2
such subclause, a notification 3
that it can no longer commence 4
commercial marketing within the 5
75-day period specified in such 6
item, such application is deemed 7
to be tentatively approved and to 8
no longer be effectively approved 9
beginning on the date that such 10
a notification is received. 11
‘‘(bb) I
NELIGIBILITY FOR 12
SUBSEQUENT EFFECTIVE AP -13
PROVAL.—If an applicant de-14
scribed in item (aa) does not 15
commence commercial marketing 16
within such 75-day period, the 17
applicant shall not be eligible for 18
a subsequent effective approval 19
for the application involved under 20
subclause (III) of subparagraph 21
(B)(iv) unless, in addition to 22
meeting each of the conditions in 23
such subclause (III), the appli-24
cant submits a certification to its 25
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abbreviated new drug application 1
that— 2
‘‘(AA) an event that 3
could not have been reason-4
ably foreseen by the appli-5
cant prevented it from com-6
mencing commercial mar-7
keting; and 8
‘‘(BB) it has fully re-9
solved any issues preventing 10
such commercial marketing 11
from commencing as a result 12
of such event. 13
‘‘(cc) T
IMING FOR SUBMIS-14
SION.—An applicant described in 15
item (aa) shall, not later than 16
one business day after com-17
mencing marketing of the drug 18
that is the subject of the applica-19
tion described in such item, sub-20
mit a notification to the abbre-21
viated new drug application con-22
firming that such applicant has 23
commenced commercial mar-24
keting of the drug.’’. 25
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(c) APPLICABILITY.—The amendments made by sub-1
sections (a) and (b) shall apply only with respect to an 2
application filed under section 505(j) of the Federal Food, 3
Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the date 4
of enactment of this Act that identifies a listed drug for 5
which no certification under paragraph (2)(A)(vii)(IV) of 6
such section was made before such date of enactment. 7
Æ
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