S 1040

Summary

Drug Competition Enhancement Act This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission (FTC) to enforce this prohibition. Generally, product hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantively similar to an indication of the reference drug. The bill establishes a presumption that product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition. The bill makes product hopping an unfair method of competition and provides for enforcement by the FTC. If the FTC has reason to believe a manufacturer has violated or is about to violate this prohibition on product hopping, the FTC may institute an administrative proceeding or bring suit in federal court to stop the manufacturer’s action and seek equitable remedies, including disgorgement of unjust profits or paying restitution to those harmed. 

Bill status

Status

Reported

Sponsor

Sen. John Cornyn [R-TX]

Cosponsors

3

Policy area

Health

Introduced

2025-03-13

Latest action

2025-04-10: Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.

Committee referrals

• Judiciary Committee: Senate · Reported By · 2025-04-10
• Judiciary Committee: Senate · Markup By · 2025-04-03
• Judiciary Committee: Senate · Referred To · 2025-03-13

Recent actions

• 2025-04-10: Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.
• 2025-04-10: Committee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.
• 2025-04-10: Committee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.
• 2025-04-03: Committee on the Judiciary. Ordered to be reported with an amendment favorably.
• 2025-03-13: Read twice and referred to the Committee on the Judiciary.