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United States · Bill · HR

H.R. 4398 (116th)

Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

referredUnited States· United States Congress· EN

Introduced

19 September 2019

Last action

2 October 2019 · Referred

Status

Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

Sponsors

David Cicilline

Subjects

Discovery layer

Source updated

3 January 2025

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 19 September 2019

    Introduced

    Referred to the House Committee on the Judiciary.

    Source: IntroReferral

  2. 19 September 2019

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 19 September 2019

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 2 October 2019

    Referred

    Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

    Source: Committee

Votes

No vote records are attached yet.

Versions

Documents

3 official files

Introduced in House (text)

View fileDownload file

Sponsors

Related records

Sources

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