Summary
# Stop STALLING Act (S. 148) – Plain English Summary
## WHAT THIS BILL DOES
This bill gives the Federal Trade Commission the power to take legal action against people or companies that file fake petitions (called "sham petitions") to delay approval of generic drugs or biosimilar drugs. A sham petition is one that has no valid basis and is filed mainly to slow down a competitor's drug approval rather than to raise real safety concerns.
## WHO IT AFFECTS
- Companies that make brand-name drugs
- Companies that make generic drugs or biosimilar drugs
- The Federal Trade Commission
- The Secretary of Health and Human Services
- Anyone who files petitions with the government about drug approvals
## KEY PROVISIONS
- A person who submits a sham petition or series of sham petitions violates federal law and can be sued by the Federal Trade Commission (Sec. 2(b))
- A covered petition is presumed (assumed) to be part of a sham series if the Secretary of Health and Human Services determines the petition was mainly filed to delay a drug approval and refers that determination to the Commission in writing (Sec. 2(c)(2))
- A company found liable can be fined up to the greater of: all money earned from selling the competing drug during the time the sham petition was being reviewed, OR $50,000 per calendar day that each sham petition was under review (Sec. 2(c)(4))
- A defendant can fight the presumption by proving, with evidence, that the series of petitions is not actually a sham (Sec. 2(c)(3))
- This law applies to any covered petition submitted on or after the bill becomes law (Sec. 2(d))
## WHAT CHANGES
If this bill becomes law, companies can face federal lawsuits and substantial financial penalties for filing fake petitions designed to block competitors' generic or biosimilar drug approvals. The Federal Trade Commission gains new power to investigate and penalize this behavior as an unfair business practice.
## IMPORTANT DEFINITIONS
- **"Sham"**: A petition that has no factual basis and tries to use the government process itself (not the actual result) to harm a competitor's business
- **"Covered petition"**: A petition filed with the government about generic drug or biosimilar drug applications
- **"Series of covered petitions"**: More than one petition about the same drug application
- **"Person"**: An individual or any type of business organization, including subsidiaries and affiliated companies
## EFFECTIVE DATE
The law applies to any covered petition submitted on or after the date the bill becomes law (Sec. 2(d)). The bill does not specify when it will become law.
II
Calendar No. 21
118TH CONGRESS
1ST SESSION
S. 148
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
JANUARY 30, 2023
Ms. KLOBUCHAR (for herself, Mr. GRASSLEY, Mr. DURBIN, Mr. BRAUN, Mr.
BLUMENTHAL, Mr. CRUZ, Mr. BOOKER, Mr. OSSOFF, and Mr. WELCH)
introduced the following bill; which was read twice and referred to the
Committee on the Judiciary
MARCH 1, 2023
Reported by Mr. DURBIN, with an amendment
[Strike out all after the enacting clause and insert the part printed in italic]
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.
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•S 148 RS
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Stop Significant and
4
Time-wasting Abuse Limiting Legitimate Innovation of
5
New Generics Act’’ or the ‘‘Stop STALLING Act’’.
6
SEC.
2.
FEDERAL
TRADE
COMMISSION
ENFORCEMENT
7
AGAINST SHAM PETITIONS.
8
(a) DEFINITIONS.—In this section:
9
(1)
COMMISSION.—The
term
‘‘Commission’’
10
means the Federal Trade Commission.
11
(2) COVERED APPLICATION.—The term ‘‘cov-
12
ered application’’ means an application filed pursu-
13
ant to subsection (b)(2) or (j) of section 505 of the
14
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
15
355) or section 351(k) of the Public Health Service
16
Act (42 U.S.C. 262(k)).
17
(3) COVERED
PETITION.—The term ‘‘covered
18
petition’’ means a petition, or a supplement to a pe-
19
tition, filed under section 505(q) of the Federal
20
Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)).
21
(4) PERSON.—The term ‘‘person’’—
22
(A) means an individual or entity; and
23
(B) includes—
24
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•S 148 RS
(i) a successor and an assign of an
1
entity;
2
(ii) a joint venture, subsidiary, part-
3
nership, division, group, and affiliate con-
4
trolled by an entity; and
5
(iii) a successor and an assign of a
6
joint venture, subsidiary, partnership, divi-
7
sion, group, and affiliate controlled by an
8
entity.
9
(5)
SERIES
OF
COVERED
PETITIONS.—The
10
term ‘‘series of covered petitions’’ means any group
11
of more than 1 covered petition relating to the same
12
covered application.
13
(6) SHAM.—The term ‘‘sham’’ means a covered
14
petition that is objectively baseless and that at-
15
tempts to use a governmental process, as opposed to
16
the outcome of that process, to interfere with the
17
business of a competitor, or a series of covered peti-
18
tions that attempts to use a governmental process,
19
as opposed to the outcome of that process, to inter-
20
fere with the business of a competitor.
21
(b) VIOLATION.—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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•S 148 RS
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) CIVIL ACTION.—
3
(1) IN 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, including
13
successors or assigns.
14
(2) PRESUMPTION.—In a civil action under
15
paragraph (1), a covered petition shall be presumed
16
to be part of a series of covered petitions that is a
17
sham under subsection (b) of this section if—
18
(A) the Secretary of Health and Human
19
Services—
20
(i) has determined that the covered
21
petition was submitted with the primary
22
purpose of delaying the approval of a cov-
23
ered application; and
24
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•S 148 RS
(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) EXCEPTION.—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) CIVIL 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 in which the
22
covered petition or series of covered petitions
23
was under review by the Secretary of Health
24
and Human Services; or
25
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•S 148 RS
(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) ANTITRUST LAWS.—Nothing in this section
6
shall modify, impair, limit, or supersede the applica-
7
bility of the antitrust laws, as defined in subsection
8
(a) of the first section of the Clayton Act (15 U.S.C.
9
12), and of section 5 of the Federal Trade Commis-
10
sion Act (15 U.S.C. 45) to the extent that it applies
11
to unfair methods of competition.
12
(6) RULE OF CONSTRUCTION.—The civil pen-
13
alty provided in this subsection is in addition to, and
14
not in lieu of, any other remedies provided by Fed-
15
eral law, including under section 16 of the Clayton
16
Act (15 U.S.C. 26) or under section 13(b) of the
17
Federal Trade Commission Act (15 U.S.C. 53(b)).
18
Nothing in this paragraph shall be construed to af-
19
fect any authority of the Commission under any
20
other provision of law.
21
(d) APPLICABILITY.—This section shall apply to any
22
covered petition submitted on or after the date of enact-
23
ment of this Act.
24
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•S 148 RS
SEC. 3. SEVERABILITY.
1
If any provision of this Act or the application of such
2
provision to any person or circumstance is held to be un-
3
constitutional, the remainder of this Act and the applica-
4
tion of the provisions of such Act to any person or cir-
5
cumstance shall not be affected.
6
SECTION 1. SHORT TITLE.
7
This Act may be cited as the ‘‘Stop Significant and
8
Time-wasting Abuse Limiting Legitimate Innovation of
9
New Generics Act’’ or the ‘‘Stop STALLING Act’’.
10
SEC. 2. FEDERAL TRADE COMMISSION ENFORCEMENT
11
AGAINST SHAM PETITIONS.
12
(a) DEFINITIONS.—In this section:
13
(1)
COMMISSION.—The
term
‘‘Commission’’
14
means the Federal Trade Commission.
15
(2) COVERED APPLICATION.—The term ‘‘covered
16
application’’ means an application filed pursuant to
17
subsection (b)(2) or (j) of section 505 of the Federal
18
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or sec-
19
tion 351(k) of the Public Health Service Act (42
20
U.S.C. 262(k)).
21
(3) COVERED PETITION.—The term ‘‘covered pe-
22
tition’’ means a petition, or a supplement to a peti-
23
tion, filed under section 505(q) of the Federal Food,
24
Drug, and Cosmetic Act (21 U.S.C. 355(q)).
25
(4) PERSON.—The term ‘‘person’’—
26
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•S 148 RS
(A) means an individual or entity; and
1
(B) includes—
2
(i) a successor or an assign of an enti-
3
ty;
4
(ii) a joint venture, subsidiary, part-
5
nership, division, group, or affiliate con-
6
trolled by an entity; and
7
(iii) a successor or an assign of a joint
8
venture, subsidiary, partnership, division,
9
group, or affiliate controlled by an entity.
10
(5) SERIES OF COVERED PETITIONS.—The term
11
‘‘series of covered petitions’’ means any group of more
12
than 1 covered petition relating to the same covered
13
application.
14
(6) SHAM.—The term ‘‘sham’’ means—
15
(A) a covered petition that—
16
(i) is objectively baseless; and
17
(ii) attempts to use a governmental
18
process, as opposed to the outcome of that
19
process, to interfere with the business of a
20
competitor; or
21
(B) a series of covered petitions that at-
22
tempts to use a governmental process, as opposed
23
to the outcome of that process, to interfere with
24
the business of a competitor.
25
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•S 148 RS
(b) VIOLATION.—A person submitting or causing the
1
submission of a covered petition or a series of covered peti-
2
tions that is a sham shall be liable for engaging in an un-
3
fair method of competition under section 5(a)(1) of the Fed-
4
eral Trade Commission Act (15 U.S.C. 45(a)(1)).
5
(c) CIVIL ACTION.—
6
(1) IN GENERAL.—If the Commission has reason
7
to believe that the submission of a covered petition or
8
a series of covered petitions constitutes a violation of
9
section 5(a)(1) of the Federal Trade Commission Act
10
(15 U.S.C. 45(a)(1)), the Commission may commence
11
a civil action to recover a civil penalty and seek other
12
appropriate relief in a district court of the United
13
States against any person that submitted or caused to
14
be submitted such covered petition or such series of
15
covered petitions.
16
(2) PRESUMPTION.—In a civil action under
17
paragraph (1), a covered petition shall be presumed
18
to be part of a series of covered petitions that is a
19
sham under subsection (b) of this section if—
20
(A) the Secretary of Health and Human
21
Services—
22
(i) has determined that the covered pe-
23
tition was submitted with the primary pur-
24
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•S 148 RS
pose of delaying the approval of a covered
1
application; and
2
(ii) has referred such determination to
3
the Commission in writing, including a
4
reasoned basis for the determination; and
5
(B) the covered petition was part of a series
6
of covered petitions.
7
(3) EXCEPTION.—The presumption in paragraph
8
(2) shall not apply if the defendant establishes, by a
9
preponderance of the evidence, that the series of cov-
10
ered petitions that includes the covered petition re-
11
ferred to the Commission by the Secretary of Health
12
and Human Services is not a sham.
13
(4) CIVIL PENALTY.—In an action under para-
14
graph (1), any person that has been found liable for
15
a violation of section 5(a)(1) of the Federal Trade
16
Commission Act (15 U.S.C. 45(a)(1)) shall be subject
17
to a civil penalty for each violation of not more than
18
the greater of—
19
(A) any revenue earned from the sale by
20
such person of any drug product, referenced in
21
a covered application that was the subject of a
22
covered petition or a series of covered petitions
23
that is a sham, during the period during which
24
the covered petition or series of covered petitions
25
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•S 148 RS
was under review by the Secretary of Health and
1
Human Services; or
2
(B) $50,000 for each calendar day that each
3
covered petition that is a sham or that was part
4
of a series of covered petitions that is a sham
5
was under review by the Secretary of Health and
6
Human Services.
7
(5) REVIEW OF REFERRAL.—No referral by the
8
Secretary of Health and Human Services under para-
9
graph (2)(A) shall be subject to judicial review, except
10
as a third-party claim asserted by the defendant
11
under section 706(2)(A) of title 5, United States Code,
12
against the Secretary of Health and Human Services
13
or the Department of Health and Human Services, as
14
part of a civil action commenced under paragraph
15
(1).
16
(6) ANTITRUST LAWS.—Nothing in this section
17
shall modify, impair, limit, or supersede the applica-
18
bility of the antitrust laws, as defined in subsection
19
(a) of the first section of the Clayton Act (15 U.S.C.
20
12), and of section 5 of the Federal Trade Commis-
21
sion Act (15 U.S.C. 45) to the extent that it applies
22
to unfair methods of competition.
23
(7) RULE OF CONSTRUCTION.—The civil penalty
24
provided in this subsection is in addition to, and not
25
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•S 148 RS
in lieu of, any other remedies provided by Federal
1
law, including under section 16 of the Clayton Act
2
(15 U.S.C. 26) or under section 13(b) of the Federal
3
Trade Commission Act (15 U.S.C. 53(b)).
4
(d) APPLICABILITY.—This section shall apply to any
5
covered petition submitted on or after the date of enactment
6
of this Act.
7
(e) RULE OF CONSTRUCTION.—Nothing in this Act
8
shall be construed to limit any authority of the Commission
9
under any other provision of law.
10
SEC. 3. SEVERABIL
[Text truncated for display. Full text available on Congress.gov.]