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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

Next stop Senate floor: awaiting a vote
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
Key points
  • 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.
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" (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
Committee referrals (1) Policy area

Health

Sponsor Amy Klobuchar (D-MN) Cosponsors · 8
■ 5 D■ 3 R