United States · Bill · HR
H.R. 4398 (116th)
Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
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
19 September 2019
Introduced
Referred to the House Committee on the Judiciary.
Source: IntroReferral
19 September 2019
Introduced
Introduced in House
Source: IntroReferral
19 September 2019
Introduced
Introduced in House
Source: IntroReferral
2 October 2019
Referred
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Source: Committee
Votes
No vote records are attached yet.
Versions
- Introduced in House · 19 September 2019 · Official file
Documents
3 official files
Introduced in House (text)
Introduced in House (text)
Introduced in House · EN · 19 September 2019
Introduced in House (PDF)
Introduced in House · EN · 19 September 2019
Introduced in House
summary · EN · 19 September 2019
Sponsors
- David Cicilline · D · Sponsor
- · hsju00 · Standing
Related records
- related to → Affordable Prescriptions for Patients Act of 2019
- related to → FUTURE Act
- related to ← Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/116th-congress/house-bill/4398
- Open data entity: https://api.congress.gov/v3/bill/116/hr/4398
- us · 116-hr-4398 · source updated 3 January 2025