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US SB1040

Bill

Status

Introduced

3/13/2025

Primary Sponsor

John Cornyn

Click for details

Origin

Senate

119th Congress

AI Summary

  • Amends the Federal Trade Commission Act to prohibit pharmaceutical "product hopping," where brand-name drug manufacturers impede generic or biosimilar competition through anticompetitive product switches

  • Defines two types of prohibited conduct: "hard switches" (withdrawing original drugs from the market while selling reformulated versions) and "soft switches" (taking actions that unfairly disadvantage original products relative to follow-on products)

  • Applies during the period from when a manufacturer receives notice of a generic/biosimilar application until 180 days after the competing product enters the market or 3 years after the follow-on product launches

  • Provides manufacturers an affirmative defense if they can demonstrate actions were taken for patient safety reasons, due to supply disruptions beyond their control, or for legitimate pro-competitive reasons

  • Grants the FTC enforcement authority including temporary and permanent injunctions, disgorgement of unjust enrichment, and restitution, with a 5-year limitations period for seeking monetary remedies

Legislative Description

Drug Competition Enhancement Act

Health

Last Action

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

4/10/2025

Committee Referrals

Judiciary3/13/2025

Full Bill Text

No bill text available