Stop Stalling Access to Affordable Medications

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. 1. Short title This Act may be cited as the Stop Stalling Access to Affordable Medications 2. Federal Trade Commission enforcement against sham petitions (a) Definitions In this section: (1) Commission The term Commission (2) Covered application The term covered application 21 U.S.C. 355 42 U.S.C. 262(k) (3) Covered petition The term covered petition 21 U.S.C. 355(q) (4) Person The term person (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 (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) (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) (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) 15 U.S.C. 45 (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 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. 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.

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.