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H.R. 4398 116th Congress House

Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

Official title: To amend the Federal Trade Commission Act to prohibit anticompetitive behaviors by drug product manufacturers, and for other purposes.

Introduced: September 19, 2019 See on congress.gov
Commerce Administrative remediesCivil actions and liabilityCompetition and antitrustConsumer affairs
More subjectsShow fewer subjects
Drug safety, medical device, and laboratory regulationFederal Trade Commission (FTC)Health care costs and insuranceInflation and pricesIntellectual propertyJudicial review and appealsManufacturingPrescription drugs
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This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 2, 2019
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Sep 19, 2019
Referred to the House Committee on the Judiciary.
Sep 19, 2019
Introduced in House
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 Latest action October 2, 2019

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

 Plain-English summary Congressional Research Service

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.

 Related & companion bills 3
  • HR 5133 Affordable Prescriptions for Patients Through Promoting Competition Act of 2019
  • S 1416 Affordable Prescriptions for Patients Act of 2019
  • HR 2486 FUTURE Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-4398/
MLA
"H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-4398/.
Bluebook (legal)
H.R. 4398, 116th Cong. (2026), https://openamerica.io/bill/116-HR-4398/.
Markdown link
[H.R. 4398: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019](https://openamerica.io/bill/116-HR-4398/)
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