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Affordable Prescriptions for Patients Through Promoting Competition Act of 2021

USA117th CongressHR-2873| House 
| Updated: 9/29/2021
David N. Cicilline

David N. Cicilline

Democratic Representative

Rhode Island

Cosponsors (5)
Val Butler Demings (Democratic)Carolyn B. Maloney (Democratic)Ken Buck (Republican)Jerrold Nadler (Democratic)Eleanor Holmes Norton (Democratic)

Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission to sue in court or institute administrative proceedings to enforce this prohibition. Generally, product-hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a changed, modified, or reformulated version of the reference drug that shares an indication (what the drug is used for) with the reference drug. The bill presumes product hopping has occurred when a reference drug manufacturer engages in a hard switch or a soft switch . A hard switch occurs when, after receiving notice of an application for Food and Drug Administration (FDA) approval to market a generic (or biosimilar) version of the reference drug, the manufacturer markets a follow-on product and (1) the FDA withdraws approval of the reference drug at the manufacturer's request, or (2) the manufacturer announces the withdrawal or discontinuance of the reference drug or destroys the drug's inventory in a manner that impedes generic competitors. Furthermore, the bill presumes that a soft switch occurred if a reference drug manufacturer (1) markets a follow-on product, and (2) takes actions that disadvantage the reference drug relative to that follow-on product in a way that impedes competition from a generic drug. A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.
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Timeline

Bill from Previous Congress

HR 116-5133
Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

Bill from Previous Congress

HR 116-4398
Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
Apr 28, 2021
Introduced in House
Apr 28, 2021
Referred to the House Committee on the Judiciary.
Sep 29, 2021
Committee Consideration and Mark-up Session Held.
Sep 29, 2021
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
  • Bill from Previous Congress

    HR 116-5133
    Affordable Prescriptions for Patients Through Promoting Competition Act of 2019


  • Bill from Previous Congress

    HR 116-4398
    Affordable Prescriptions for Patients Through Promoting Competition Act of 2019


  • April 28, 2021
    Introduced in House


  • April 28, 2021
    Referred to the House Committee on the Judiciary.


  • September 29, 2021
    Committee Consideration and Mark-up Session Held.


  • September 29, 2021
    Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.

Commerce

Related Bills

  • HR 117-5260: Reduced Costs and Continued Cures Act
  • HR 117-5237: Reduced Costs and Continued Cures Act of 2021
  • S 117-1435: Affordable Prescriptions for Patients Act of 2021
Administrative remediesCivil actions and liabilityCompetition and antitrustConsumer affairsDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Health care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsManufacturingPrescription drugs

Affordable Prescriptions for Patients Through Promoting Competition Act of 2021

USA117th CongressHR-2873| House 
| Updated: 9/29/2021
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission to sue in court or institute administrative proceedings to enforce this prohibition. Generally, product-hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a changed, modified, or reformulated version of the reference drug that shares an indication (what the drug is used for) with the reference drug. The bill presumes product hopping has occurred when a reference drug manufacturer engages in a hard switch or a soft switch . A hard switch occurs when, after receiving notice of an application for Food and Drug Administration (FDA) approval to market a generic (or biosimilar) version of the reference drug, the manufacturer markets a follow-on product and (1) the FDA withdraws approval of the reference drug at the manufacturer's request, or (2) the manufacturer announces the withdrawal or discontinuance of the reference drug or destroys the drug's inventory in a manner that impedes generic competitors. Furthermore, the bill presumes that a soft switch occurred if a reference drug manufacturer (1) markets a follow-on product, and (2) takes actions that disadvantage the reference drug relative to that follow-on product in a way that impedes competition from a generic drug. A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-5133
Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

Bill from Previous Congress

HR 116-4398
Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
Apr 28, 2021
Introduced in House
Apr 28, 2021
Referred to the House Committee on the Judiciary.
Sep 29, 2021
Committee Consideration and Mark-up Session Held.
Sep 29, 2021
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
  • Bill from Previous Congress

    HR 116-5133
    Affordable Prescriptions for Patients Through Promoting Competition Act of 2019


  • Bill from Previous Congress

    HR 116-4398
    Affordable Prescriptions for Patients Through Promoting Competition Act of 2019


  • April 28, 2021
    Introduced in House


  • April 28, 2021
    Referred to the House Committee on the Judiciary.


  • September 29, 2021
    Committee Consideration and Mark-up Session Held.


  • September 29, 2021
    Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
David N. Cicilline

David N. Cicilline

Democratic Representative

Rhode Island

Cosponsors (5)
Val Butler Demings (Democratic)Carolyn B. Maloney (Democratic)Ken Buck (Republican)Jerrold Nadler (Democratic)Eleanor Holmes Norton (Democratic)

Judiciary Committee

Commerce

Related Bills

  • HR 117-5260: Reduced Costs and Continued Cures Act
  • HR 117-5237: Reduced Costs and Continued Cures Act of 2021
  • S 117-1435: Affordable Prescriptions for Patients Act of 2021
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative remediesCivil actions and liabilityCompetition and antitrustConsumer affairsDrug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Health care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsManufacturingPrescription drugs