Stop STALLING Act

Bill: 118-s-148
Sponsor: full_name: Sen. Klobuchar, Amy [D-MN]
Introduced: 2023-01-30
Policy area: Health
Subjects: 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
Latest action: action_date: 2023-03-01
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 21.

Summaries:
action_date: 2023-01-30
action_desc: Introduced in Senate
text: <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>

action_date: 2023-03-01
action_desc: Reported to Senate
text: <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>

tv_txt: II Calendar No. 21 118th CONGRESS 1st Session S. 148 IN THE SENATE OF THE UNITED STATES January 30, 2023 Ms. Klobuchar (for herself, Mr. Grassley , Mr. Durbin , Mr. Braun , Mr. Blumenthal , Mr. Cruz , Mr. Booker , Mr. Ossoff , and Mr. Welch ) introduced the following bill; which was read twice and referred to the Committee on the Judiciary March 1, 2023 Reported by Mr. Durbin , with an amendment Strike out all after the enacting clause and insert the part printed in italic 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.

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 . 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. 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.

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 . 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. 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.

March 1, 2023 Reported with an amendment

tv_txt: II 118th CONGRESS 1st Session S. 148 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.

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 . 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. 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.