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Increasing Prescription Drug Competition Act

H.R. 4692 Rep. Elissa Slotkin (D-MI-7) In committee
Bill text PDF
  1. Introduced Jul 17
  2. Committee Jul 17
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Jul 17, 2023Next: House vote
1195d ago Jul 21, 2023: Referred to the Subcommittee on Health.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
2companies, 4 filings
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Companies lobbying on this bill

2 companies
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Biotech & Pharma 2
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Summary

Increasing Prescription Drug Competition Act

Full summary3 paragraphs

This bill provides that certifications in generic drug applications of certain patents involved in Risk Evaluation and Mitigation Strategy (REMS) programs have no effect upon the drug's approval. (The Food and Drug Administration sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through elements to ensure safe use (ETASU), such as special requirements for pharmacies that dispense the drug.)

Specifically, certifications in generic drug applications with respect to patents that involve an ETASU for REMS requirements have no effect on the effective date of the drug's approval, notwithstanding any other provisions that allow for a stay of approval pending litigation outcomes (i.e., 30-month stay).

The bill also specifies that in a civil action alleging patent infringement with respect to REMS requirements, the sponsor of the approved brand-name drug may only seek damages from (rather than an injunction against) the generic drug applicant.

Library of Congress summary, Jul 17, 2023

Summary versions
  • Introduced in HouseJul 17, 2023

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.