II
Calendar No. 45
119THCONGRESS
1
STSESSION S. 1095
To enable the Federal Trade Commission to deter filing of sham citizen
petitions to cover an attempt to interfere with approval of a competing
generic drug or biosimilar, to foster competition, and facilitate the effi-
cient review of petitions filed in good faith to raise legitimate public
health concerns, and for other purposes.
IN THE SENATE OF THE UNITED STATES
MARCH24, 2025
Ms. K
LOBUCHAR (for herself, Mr. GRASSLEY, Mr. DURBIN, Mr.
B
LUMENTHAL, Mr. CRUZ, Mr. WELCH, and Mr. BOOKER) introduced the
following bill; which was read twice and referred to the Committee on the
Judiciary
A
PRIL10, 2025
Reported by Mr. G
RASSLEY, without amendment
A BILL
To enable the Federal Trade Commission to deter filing
of sham citizen petitions to cover an attempt to interfere
with approval of a competing generic drug or biosimilar,
to foster competition, and facilitate the efficient review
of petitions filed in good faith to raise legitimate public
health concerns, and for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
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SECTION 1. SHORT TITLE. 1
This Act may be cited as the ‘‘Stop Significant and 2
Time-wasting Abuse Limiting Legitimate Innovation of 3
New Generics Act’’ or the ‘‘Stop STALLING Act’’. 4
SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT 5
AGAINST SHAM PETITIONS. 6
(a) D
EFINITIONS.—In this section: 7
(1) C
OMMISSION.—The term ‘‘Commission’’ 8
means the Federal Trade Commission. 9
(2) C
OVERED APPLICATION .—The term ‘‘cov-10
ered application’’ means an application filed pursu-11
ant to subsection (b)(2) or (j) of section 505 of the 12
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 13
355) or section 351(k) of the Public Health Service 14
Act (42 U.S.C. 262(k)). 15
(3) C
OVERED PETITION.—The term ‘‘covered 16
petition’’ means a petition, or a supplement to a pe-17
tition, filed under section 505(q) of the Federal 18
Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)). 19
(4) P
ERSON.—The term ‘‘person’’— 20
(A) means an individual or entity; and 21
(B) includes— 22
(i) a successor or an assign of an enti-23
ty; 24
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•S 1095 RS
(ii) a joint venture, subsidiary, part-1
nership, division, group, or affiliate con-2
trolled by an entity; and 3
(iii) a successor or an assign of a joint 4
venture, subsidiary, partnership, division, 5
group, or affiliate controlled by an entity. 6
(5) S
ERIES OF COVERED PETITIONS .—The 7
term ‘‘series of covered petitions’’ means any group 8
of more than 1 covered petition relating to the same 9
covered application. 10
(6) S
HAM.—The term ‘‘sham’’ means— 11
(A) a covered petition that— 12
(i) is objectively baseless; and 13
(ii) attempts to use a governmental 14
process, as opposed to the outcome of that 15
process, to interfere with the business of a 16
competitor; or 17
(B) a series of covered petitions that at-18
tempts to use a governmental process, as op-19
posed to the outcome of that process, to inter-20
fere with the business of a competitor. 21
(b) V
IOLATION.—A person submitting or causing the 22
submission of a covered petition or a series of covered peti-23
tions that is a sham shall be liable for engaging in an 24
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unfair method of competition under section 5(a)(1) of the 1
Federal Trade Commission Act (15 U.S.C. 45(a)(1)). 2
(c) C
IVILACTION.— 3
(1) I
N GENERAL.—If the Commission has rea-4
son to believe that the submission of a covered peti-5
tion or a series of covered petitions constitutes a vio-6
lation of section 5(a)(1) of the Federal Trade Com-7
mission Act (15 U.S.C. 45(a)(1)), the Commission 8
may commence a civil action to recover a civil pen-9
alty and seek other appropriate relief in a district 10
court of the United States against any person that 11
submitted or caused to be submitted such covered 12
petition or such series of covered petitions. 13
(2) P
RESUMPTION.—In a civil action under 14
paragraph (1), a covered petition shall be presumed 15
to be part of a series of covered petitions that is a 16
sham under subsection (b) of this section if— 17
(A) the Secretary of Health and Human 18
Services— 19
(i) has determined that the covered 20
petition was submitted with the primary 21
purpose of delaying the approval of a cov-22
ered application; and 23
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(ii) has referred such determination to 1
the Commission in writing, including a rea-2
soned basis for the determination; and 3
(B) the covered petition was part of a se-4
ries of covered petitions. 5
(3) E
XCEPTION.—The presumption in para-6
graph (2) shall not apply if the defendant estab-7
lishes, by a preponderance of the evidence, that the 8
series of covered petitions that includes the covered 9
petition referred to the Commission by the Secretary 10
of Health and Human Services is not a sham. 11
(4) C
IVIL PENALTY.—In an action under para-12
graph (1), any person that has been found liable for 13
a violation of section 5(a)(1) of the Federal Trade 14
Commission Act (15 U.S.C. 45(a)(1)) shall be sub-15
ject to a civil penalty for each violation of not more 16
than the greater of— 17
(A) any revenue earned from the sale by 18
such person of any drug product, referenced in 19
a covered application that was the subject of a 20
covered petition or a series of covered petitions 21
that is a sham, during the period during which 22
the covered petition or series of covered peti-23
tions was under review by the Secretary of 24
Health and Human Services; or 25
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(B) $50,000 for each calendar day that 1
each covered petition that is a sham or that was 2
part of a series of covered petitions that is a 3
sham was under review by the Secretary of 4
Health and Human Services. 5
(5) R
EVIEW OF REFERRAL .—No referral by the 6
Secretary of Health and Human Services under 7
paragraph (2)(A) shall be subject to judicial review, 8
except as a third-party claim asserted by the defend-9
ant under section 706(2)(A) of title 5, United States 10
Code, against the Secretary of Health and Human 11
Services or the Department of Health and Human 12
Services, as part of a civil action commenced under 13
paragraph (1). 14
(6) A
NTITRUST LAWS.—Nothing in this section 15
shall modify, impair, limit, or supersede the applica-16
bility of the antitrust laws, as defined in subsection 17
(a) of the first section of the Clayton Act (15 U.S.C. 18
12), and of section 5 of the Federal Trade Commis-19
sion Act (15 U.S.C. 45) to the extent that it applies 20
to unfair methods of competition. 21
(7) R
ULE OF CONSTRUCTION .—The civil pen-22
alty provided in this subsection is in addition to, and 23
not in lieu of, any other remedies provided by Fed-24
eral law, including under section 16 of the Clayton 25
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Act (15 U.S.C. 26) or under section 13(b) of the 1
Federal Trade Commission Act (15 U.S.C. 53(b)). 2
(d) A
PPLICABILITY.—This section shall apply to any 3
covered petition submitted on or after the date of enact-4
ment of this Act. 5
(e) R
ULE OFCONSTRUCTION.—Nothing in this Act 6
shall be construed to limit any authority of the Commis-7
sion under any other provision of law. 8
SEC. 3. SEVERABILITY. 9
If any provision of this Act or the application of such 10
provision to any person or circumstance is held to be un-11
constitutional, the remainder of this Act and the applica-12
tion of the provisions of such Act to any person or cir-13
cumstance shall not be affected. 14
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45
119
TH
CONGRESS
1
ST
S
ESSION
S. 1095 A BILL
To enable the Federal Trade Commission to deter
filing of sham citizen petitions to cover an at-
tempt to interfere with approval of a competing
generic drug or biosimilar, to foster competition,
and facilitate the efficient review of petitions
filed in good faith to raise legitimate public
health concerns, and for other purposes.
A
PRIL
10, 2025
Reported without amendment
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