S. 1095

119 S1095 IS: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act
 U.S. Senate
 2025-03-24
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 II  119th CONGRESS  1st Session  S. 1095  IN THE SENATE OF THE UNITED STATES   March 24, 2025   Ms. Klobuchar  (for herself,  Mr. Grassley ,  Mr. Durbin ,  Mr. Blumenthal ,  Mr. Cruz ,  Mr. Welch , and  Mr. Booker ) introduced the following bill; which was read twice and referred to the  Committee on the Judiciary    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.
1.
Short title
This Act may be cited as the   Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act   or the   Stop STALLING Act  .
2.
Federal Trade Commission enforcement against sham petitions
(a)
Definitions
In this section:
(1)
Commission
The term  Commission  means the Federal Trade Commission.
(2)
Covered application
The term  covered application  means an application filed pursuant to subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ).
(3)
Covered petition
The term  covered petition  means a petition, or a supplement to a petition, filed under section 505(q) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(q) ).
(4)
Person
The term  person —
(A)
means an individual or entity; and
(B)
includes—
(i)
a successor or an assign of an entity;
(ii)
a joint venture, subsidiary, partnership, division, group, or affiliate controlled by an entity; and
(iii)
a successor or an assign of a joint venture, subsidiary, partnership, division, group, or affiliate controlled by an entity.
(5)
Series of covered petitions
The term  series of covered petitions  means any group of more than 1 covered petition relating to the same covered application.
(6)
Sham
The term  sham  means—
(A)
a covered petition that—
(i)
is objectively baseless; and
(ii)
attempts to use a governmental process, as opposed to the outcome of that process, to interfere with the business of a competitor; or
(B)
a series of covered petitions that attempts to use a governmental process, as opposed to the outcome of that process, to interfere with the business of a competitor.
(b)
Violation
A person submitting or causing the submission of a covered petition or a series of covered petitions that is a sham shall be liable for engaging in an unfair method of competition under section 5(a)(1) of the Federal Trade Commission Act ( 15 U.S.C. 45(a)(1) ).
(c)
Civil action
(1)
In general
If the Commission has reason to believe that the submission of a covered petition or a series of covered petitions constitutes a violation of section 5(a)(1) of the Federal Trade Commission Act ( 15 U.S.C. 45(a)(1) ), the Commission may commence a civil action to recover a civil penalty and seek other appropriate relief in a district court of the United States against any person that submitted or caused to be submitted such covered petition or such series of covered petitions.
(2)
Presumption
In a civil action under paragraph (1), a covered petition shall be presumed to be part of a series of covered petitions that is a sham under subsection (b) of this section if—
(A)
the Secretary of Health and Human Services—
(i)
has determined that the covered petition was submitted with the primary purpose of delaying the approval of a covered application; and
(ii)
has referred such determination to the Commission in writing, including a reasoned basis for the determination; and
(B)
the covered petition was part of a series of covered petitions.
(3)
Exception
The presumption in paragraph (2) shall not apply if the defendant establishes, by a preponderance of the evidence, that the series of covered petitions that includes the covered petition referred to the Commission by the Secretary of Health and Human Services is not a sham.
(4)
Civil penalty
In an action under paragraph (1), any person that has been found liable for a violation of section 5(a)(1) of the Federal Trade Commission Act ( 15 U.S.C. 45(a)(1) ) shall be subject to a civil penalty for each violation of not more than the greater of—
(A)
any revenue earned from the sale by such person of any drug product, referenced in a covered application that was the subject of a covered petition or a series of covered petitions that is a sham, during the period during which the covered petition or series of covered petitions was under review by the Secretary of Health and Human Services; or
(B)
$50,000 for each calendar day that each covered petition that is a sham or that was part of a series of covered petitions that is a sham was under review by the Secretary of Health and Human Services.
(5)
Review of referral
No referral by the Secretary of Health and Human Services under paragraph (2)(A) shall be subject to judicial review, except as a third-party claim asserted by the defendant under section 706(2)(A) of title 5, United States Code, against the Secretary of Health and Human Services or the Department of Health and Human Services, as part of a civil action commenced under paragraph (1).
(6)
Antitrust laws
Nothing in this section shall modify, impair, limit, or supersede the applicability of the antitrust laws, as defined in subsection (a) of the first section of the Clayton Act ( 15 U.S.C. 12 ), and of section 5 of the Federal Trade Commission Act ( 15 U.S.C. 45 ) to the extent that it applies to unfair methods of competition.
(7)
Rule of construction
The civil penalty provided in this subsection is in addition to, and not in lieu of, any other remedies provided by Federal law, including under section 16 of the Clayton Act ( 15 U.S.C. 26 ) or under section 13(b) of the Federal Trade Commission Act ( 15 U.S.C. 53(b) ).
(d)
Applicability
This section shall apply to any covered petition submitted on or after the date of enactment of this Act.
(e)
Rule of construction
Nothing in this Act shall be construed to limit any authority of the Commission under any other provision of law.
3.
Severability
If any provision of this Act or the application of such provision to any person or circumstance is held to be unconstitutional, the remainder of this Act and the application of the provisions of such Act to any person or circumstance shall not be affected.