PlainBillCongress, translated.Legislation. Context. Public interest.Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
Congressional Research Service
Version 00 · Introduced in House · Apr 28, 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.
Showing the opening paragraphs of the official summary.
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.
People & committees
Rep. Cicilline, David N. [D-RI-1] · D–RI
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
Committee Consideration and Mark-up Session Held.
Referred to the House Committee on the Judiciary.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We currently store references to these documents.
Source last updated: Apr 7, 2025. Consult Congress.gov for the current record.
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