Title: Stop Stalling Access to Affordable Medications
Policy area: Health

Summary:
Stop Stalling Access to Affordable Medications
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.
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.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2883 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 2883

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 heath concerns, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 28, 2021

  Mr. Jeffries (for himself, Mr. Buck, Mr. Nadler, Mr. Cicilline, and 
  Mrs. Carolyn B. Maloney of New York) introduced the following bill; 
          which was 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 heath 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 Stalling Access to Affordable 
Medications''.

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'' means--
                    (A) an individual or entity;
                    (B) its directors, officers, employees, agents, 
                representatives, successors, and assigns; and
                    (C) the joint ventures, subsidiaries, partnerships, 
                divisions, groups, and affiliates it controls, and the 
                respective directors, officers, employees, agents, 
                representatives, successors, and assigns of each.
            (5) Series of covered petitions.--The term ``series of 
        covered petitions'' means any group of more than one covered 
        petition.
            (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.--
            (1) In general.--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 the Secretary of Health and Human Services has 
        determined that the covered petition was submitted with the 
        primary purpose of delaying the approval of a covered 
        application, was part of a series of covered petitions, and has 
        referred such determination to the Federal Trade Commission in 
        writing, with a reasoned basis for the determination.
            (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(a)), 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, an amendment made by this Act, or the 
application of such provision or amendment to any person or 
circumstance is held to be unconstitutional, the remainder of this Act, 
the amendments made by this Act, and the application of the provisions 
of such Act or amendments to any person or circumstance shall not be 
affected.
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