S1040Reported by Committee

Drug Competition Enhancement Act

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Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-03-13
Introduced
3
Cosponsors
S
ⓘ
Type

Sponsor

John Cornyn
John Cornyn
Republican · TX · Senator
Votes with party: 76.8% (902 recorded votes)
Top industries funding sponsor:
  • Conservative Groups$79,418k
  • Climate & Environment$24,960k

Full profile: /officials/C001056

Source: Congress.gov · FEC

Cosponsors (3)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

3 cosponsors on record at Congress.gov. The named list is syncing into Govwatch and will appear here shortly — view on Congress.gov in the meantime.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.

2025-04-10

Source: Congress.gov

Committee Activity

Currently in

Previously

Plain-English 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.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Health
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