United States 116th Congress Status: Died 1 D cosponsors

HR 4398 — Affordable Prescriptions for Patients Through Promoting Competition Act of 2019

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

Track this bill free

No card. One bill, free forever — alerts when it moves.

  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

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.

Bill Text

Sections of law this bill changes

1 section in 1 law

From the bill's own amending language, matched to the official United States Code (current through Public Law 119-124).

Federal trade commission; promotion of export trade and prevention of unfair methods of competition · 15 U.S.C. ch. 2 Amends the act as a whole

Also cites: 5 U.S.C. § 553, 15 U.S.C. § 12, 15 U.S.C. § 45, 15 U.S.C. § 57c-2, 21 U.S.C. § 355, 21 U.S.C. § 355a, 42 U.S.C. § 262

How this bill changes current law

1 change Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill adds a new section to the Federal Trade Commission Act to prohibit anticompetitive behaviors by drug manufacturers, specifically addressing 'product hopping'.

  • 15 U.S.C. 41 et seq.

    SEC. 27. PRODUCT HOPPING. (a) Definitions.--In this section: ... (b) Prohibition on Product Hopping.--

    This change introduces a new section defining and prohibiting practices related to product hopping by manufacturers of referenced drugs.

Action History

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

  2. Introduced in House

  3. Introduced in House

  4. Referred to the House Committee on the Judiciary.

Sponsors

Sponsorship breakdown

Export CSV (upgrade) →

1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

Show all 546 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

finance healthcare health-insurance
Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

What does HR 4398 do?
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.
Who sponsors HR 4398?
HR 4398 is sponsored by Cicilline, David N. (Democratic).
What is the current status of HR 4398?
This bill died with 116th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 4398?
Track HR 4398 free on One Click Politics — get push/email alerts when it moves.

Make your voice heard on HR 4398

Find the representatives who decide this bill and tell them where you stand — for yourself, or mobilize your whole list in one click with One Click Politics advocacy software.

Find my representatives → Run a campaign

Stay ahead of HR 4398

Last checked for changes 3 months ago · updated continuously

One Click Politics tracks every bill in Congress and all 50 states.

Track this bill →