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Increasing Prescription Drug Competition Act

S. 574 Sen. Maggie Hassan (D-NH) In committee
Bill text PDF
  1. Introduced Mar 1
  2. Committee Mar 1
  3. Passed Senate Next
  4. Passed House Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Mar 1, 2023Next: Senate vote
1337d ago Mar 1, 2023: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
2companies, 2 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, Mar 1, 2023

Summary versions
  • Introduced in SenateMar 1, 2023

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