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
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
- 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.
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- Judiciary Committee (Senate)
Health
■ 2 D■ 1 R
2 Democrats
1 Republican