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Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

USA116th CongressHR-4398| House 
| Updated: 10/2/2019
David N. Cicilline

David N. Cicilline

Democratic Representative

Rhode Island

Administrative State, Regulatory Reform, and Antitrust Subcommittee, Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a hard switch or a soft switch . A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A follow-on product is a changed, modified, or reformulated version of a manufacturer’s already-approved drug or biological product that still treats the same medical condition. A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product. A drug manufacturer may rebut a presumption of product hopping by demonstrating that its conduct was not intended to limit competition.
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Timeline
Sep 19, 2019
Introduced in House
Sep 19, 2019
Referred to the House Committee on the Judiciary.
Oct 2, 2019
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
  • September 19, 2019
    Introduced in House


  • September 19, 2019
    Referred to the House Committee on the Judiciary.


  • October 2, 2019
    Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

Commerce

Related Bills

  • HR 116-5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
  • S 116-1416: Affordable Prescriptions for Patients Act of 2019
  • HR 116-2486: FUTURE Act
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 2019

USA116th CongressHR-4398| House 
| Updated: 10/2/2019
Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 This bill prohibits product hopping by drug manufacturers. Product hopping is presumed when a drug manufacturer engages is a hard switch or a soft switch . A hard switch occurs when, after a manufacturer receives notice of an application for a generic drugs, either, (1) the manufacturer obtains removal of a drug from the Food and Drug Administration’s approved drug list or the drug is moved to the discontinued products list, and the manufacturer markets or sells a follow-on product; or (2) a manufacturer announces the withdrawal or discontinuance of a listed drug, or the manufacturer destroys the inventory of a listed drug in a manner that impedes generic drug competitors, and the manufacturer markets or sells a follow-on product. A follow-on product is a changed, modified, or reformulated version of a manufacturer’s already-approved drug or biological product that still treats the same medical condition. A soft switch occurs when a manufacturer receives notice of an application for a generic drugs, takes other actions that impede generic drug competitors, and the manufacturer markets or sells a follow-on product. A drug manufacturer may rebut a presumption of product hopping 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
Sep 19, 2019
Introduced in House
Sep 19, 2019
Referred to the House Committee on the Judiciary.
Oct 2, 2019
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
  • September 19, 2019
    Introduced in House


  • September 19, 2019
    Referred to the House Committee on the Judiciary.


  • October 2, 2019
    Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
David N. Cicilline

David N. Cicilline

Democratic Representative

Rhode Island

Administrative State, Regulatory Reform, and Antitrust Subcommittee, Judiciary Committee

Commerce

Related Bills

  • HR 116-5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
  • S 116-1416: Affordable Prescriptions for Patients Act of 2019
  • HR 116-2486: FUTURE Act
  • 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