Stop STALLING Act

Subjects: Health, Administrative remedies, Business ethics, Civil actions and liability, Competition and antitrust, Department of Health and Human Services, Drug safety, medical device, and laboratory regulation, Food and Drug Administration (FDA), Licensing and registrations, Prescription drugs, Public participation and lobbying

Summary:  <p><b>Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act or the</b> <b>Stop STALLING Act</b></p> <p>This bill makes it an unfair method of competition to submit an objectively baseless petition to the Food and Drug Administration (FDA) in an attempt to interfere with a competitor's application for market approval of a drug.</p> <p>The bill authorizes the Federal Trade Commission to sue an individual or entity that submits such a petition to the FDA.	 A party found liable in such a lawsuit shall be subject to civil penalties, such as a fine of up to $50,000 for each day that the FDA spent reviewing the baseless petition.</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 148 Introduced in Senate (IS)]

&lt;DOC&gt;






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 
 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

                            January 30, 2023

 Ms. Klobuchar (for herself, Mr. Grassley, Mr. Durbin, Mr. Braun, Mr. 
 Blumenthal, Mr. Cruz, 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.

    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 and an assign of an entity;
                            (ii) a joint venture, subsidiary, 
                        partnership, division, group, and affiliate 
                        controlled by an entity; and
                            (iii) a successor and an assign of a joint 
                        venture, subsidiary, partnership, division, 
                        group, and 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 covered petition that 
        is objectively baseless and that attempts to use a governmental 
        process, as opposed to the outcome of that process, to 
        interfere with the business of a competitor, or 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, including successors or assigns.
            (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 in 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) 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.
            (6) 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)). Nothing in 
        this paragraph shall be construed to affect any authority of 
        the Commission under any other provision of law.
    (d) Applicability.--This section shall apply to any covered 
petition submitted on or after the date of enactment of this Act.

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.
                                 &lt;all&gt;
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