119-s1095

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1095 Reported in Senate

    (RS) ]

<DOC>

 Calendar No. 45
119th CONGRESS
 1st Session
 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 
 efficient review of petitions filed in good faith to raise legitimate 
 public health concerns, and for other purposes.

_______________________________________________________________________

 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

 April 10, 2025

 Reported by Mr. Grassley, 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 Representatives of the 
United States of America in Congress assembled,

SECTION 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''.

SEC. 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.

SEC. 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.
 Calendar No. 45

119th CONGRESS

 1st Session

 S. 1095

_______________________________________________________________________

 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.

_______________________________________________________________________

 April 10, 2025

 Reported without amendment