S. 1040 · 119th Congress
Drug Competition Enhancement Act
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R
CornynSponsor3 cosponsors · 2 D, 1 R
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission (FTC) to enforce this prohibition.
What it does: CRS summary · Introduced in Senate · Mar 13, 2025
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Drug Competition Enhancement Act
Latest action (Apr 10, 2025): Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.
Policy area: Health · Origin: Senate · Introduced: Mar 13, 2025
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.