S 1096
Advanced toward a vote
Makes it unlawful for brand-name drug makers to pay generic or biosimilar competitors to delay their market entry, and treats such agreements as unfair competition enforced by the Federal Trade Commission.
Official title: Preserve Access to Affordable Generics and Biosimilars Act
Timeline each lane is a chamber; dates pull from congress.gov actions
Senate
Introduced
24-MAR-2025
Referred
24-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, presuming an agreement anticompetitive when a generic or biosimilar filer receives something of value and agrees to limit its own sales, unless the parties show otherwise.
- Sets civil penalties of up to three times the value received and lists exclusions for payments limited to a set entry date, reasonable litigation expenses up to $7,500,000 in 2025, or a covenant not to sue.
- Requires parties to file a certified statement that their filed agreements are complete, and allows the FTC six years after that filing to bring enforcement proceedings.
- Removes a generic drug maker's 180-day exclusivity period when its agreement violates the new section.
Covers an older version. The newest CRS summary describes the bill as of "Introduced in Senate" (24-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
■ 5 D■ 3 R
3 Republicans