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H.R. 4398 · 116th Congress

Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

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Never voted on. It didn't reach a floor vote before the 116th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

No cosponsors.

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 .

What it does: CRS summary · Introduced in House · Sep 19, 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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

Latest action (Oct 2, 2019): Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

Policy area: Commerce · Origin: House · Introduced: Sep 19, 2019

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.