Drug Competition Enhancement Act
Sponsored By: Senator Sen. Cornyn, John [R-TX]
In Committee
Summary
Stops "product hopping" by drugmakers to protect competition from generics and biosimilars. It would add a new FTC rule that treats certain deliberate formulation or marketing shifts as unfair methods of competition and lets the agency seek injunctions and other remedies.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
New limits on drugmaker product hopping
If enacted, the bill would set limits on brand‑name drug makers shifting patients to a new version to block generics. The FTC could presume unfair conduct in a set window: from notice of a generic or biosimilar filing until the earlier of 180 days after the first generic/biosimilar is sold or 3 years after the follow‑on is first sold. A hard switch would include pulling or discontinuing the old drug to push a follow‑on, unless FDA asked for it. A soft switch would cover other actions that unfairly hurt the old drug while the follow‑on is sold. Objective facts could be used to prove this. The bill would define key terms like generic, biosimilar, listed drug, follow‑on product, and manufacturer. A company could avoid liability only if it would have acted the same anyway and has a valid safety reason, an uncontrollable supply problem that reasonable efforts cannot fix, or another real pro‑competitive reason. Truthful, non‑misleading ads, or simply stopping ads, by themselves would not be banned.
Stronger FTC tools to police drug switching
If enacted, the FTC would get clearer tools to enforce these rules. It could bring administrative cases or sue in federal court for temporary or permanent orders. The FTC could seek to give up unfair profits and repay buyers within 5 years of the last unfair gain, with disgorgement reduced by any restitution paid. The FTC could issue rules to define terms not already defined. A manufacturer could appeal a final cease‑and‑desist order within 30 days to the D.C. Circuit or the circuit where its parent is incorporated; FTC fact findings would stand if supported by evidence. The bill would not limit other antitrust laws. These changes would apply to conduct and cases that begin on or after enactment.
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Sponsors & CoSponsors
Sponsor
Sen. Cornyn, John [R-TX]
TX • R
Cosponsors
Richard Blumenthal
CT • D
Sponsored 3/13/2025
Sen. Grassley, Chuck [R-IA]
IA • R
Sponsored 3/13/2025
Sen. Durbin, Richard J. [D-IL]
IL • D
Sponsored 3/13/2025
Roll Call Votes
No roll call votes available for this bill.
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