[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Pages S5082-S5083]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2871. Ms. KLOBUCHAR (for herself and Mr. Grassley) submitted an 
amendment intended to be proposed by her to the bill S. 4638, to 
authorize appropriations for fiscal year 2025 for military activities 
of the Department of Defense, for military construction, and for 
defense activities of the Department of Energy, to prescribe military 
personnel strengths for such fiscal year, and for other purposes; which 
was ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. _____. 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

[[Page S5083]]

     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 section shall be 
     construed to limit any authority of the Commission under any 
     other provision of law.
       (f) Severability.--If any provision of this section or the 
     application of such provision to any person or circumstance 
     is held to be unconstitutional, the remainder of this section 
     and the application of the provisions of such section to any 
     person or circumstance shall not be affected.
                                 ______