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S. 1040: Drug Competition Enhancement Act
119th Congress · introduced 2025-03-13 · Health · Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.
federal
Official title
Drug Competition Enhancement Act
Plain 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.
Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.
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What does this mean? (plain words)
Official text
Drug Competition Enhancement Act
Source: Congressional Research Service summary (Introduced in Senate)
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Officials and money
Sponsor: Sen. Cornyn, John [R-TX] · 3 cosponsors
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Words on this page, explained (1)
- Bill
- A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Introduced in Senate)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-119s1040.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/119/s>
Record fed-us-cong119-s1040 · catalog fed-us-congress-bills-cong119 · updated 2026-11-03 by psicol fed-bills