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S 1040 Advanced toward a vote

Prohibits drugmakers from pulling a brand-name drug or biologic off the market or shifting sales to a slightly altered version in ways that impede generic or biosimilar competition, and lets the Federal Trade Commission enforce the ban.

Official title: Drug Competition Enhancement Act

Next stop Senate floor: awaiting a vote
Timeline each lane is a chamber; dates pull from congress.gov actions
Senate
Introduced 13-MAR-2025
Referred 13-MAR-2025
Approved by committee 03-APR-2025
Reported 10-APR-2025
On the calendar 10-APR-2025
Key points
  • Adds Section 27 to the Federal Trade Commission Act, covering "hard switches" such as withdrawing a listed drug or destroying its inventory, and "soft switches" that unfairly disadvantage the original product.
  • Applies the ban from the time a manufacturer learns of an abbreviated new drug application or biosimilar license application until 180 days after generic or biosimilar entry or 3 years after the follow-on product is marketed.
  • Allows a manufacturer to justify its conduct with safety reasons, an uncontrollable supply disruption, or legitimate pro-competitive reasons, which the Commission may rebut.
  • Lets the Commission seek injunctions, disgorgement, and restitution in federal court, with a 5-year limitations period, and permits the Commission to issue rules defining terms.
AI-generated from the Reported to Senate text of 10-APR-2025 · verify · report an error
Official CRS summary

Covers an older version. The newest CRS summary describes the bill as of "Introduced in Senate" (13-MAR-2025); the text has changed since (Reported to Senate, 10-APR-2025).

CRS is the Library of Congress's nonpartisan research office. Read it on congress.gov
Committee referrals (1) Policy area

Health

Sponsor John Cornyn (R-TX) Cosponsors · 3
■ 2 D■ 1 R
1 Republican