119th Congress Health
S. 1040: Drug Competition Enhancement Act
Reported
- Introduced (completed)
- Passed Senate (not reached)
- Passed House (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
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.
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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 Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Richard Blumenthal D-CTOriginal
- Richard Durbin D-ILOriginal
- Charles Grassley R-IAOriginal
Who scored on this bill
- 1John Cornyn SponsorDrew cross-party cosponsors, introduced, reported3 events+26
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Introductions and cosponsorships count toward weekly caps and show no points.
Other bills by John Cornyn
History
- Introduced in the Senate by John Cornyn.
Show the full action history (5 actions)
- Committee on the Judiciary. Reported by Senator Grassley with an amendment. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.
- Committee on the Judiciary. Ordered to be reported with an amendment favorably.
- Introduced in Senate
- Read twice and referred to the Committee on the Judiciary.