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Promising Pathway Act

S. 1906 Sen. Mike Braun (R-IN) In committee
Bill text PDF
  1. Introduced Jun 8
  2. Committee Jun 8
  3. Passed Senate Next
  4. Passed House Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Jun 8, 2023Next: Senate vote
1238d ago Jun 8, 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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Member trades
1trades in the last 90 days
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Companies lobbying on this bill

2 companies
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Biotech & Pharma 2
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Summary

Promising Pathway Act

Full summary3 paragraphs

This bill provides for expedited, provisional approval of drugs for serious or life-threatening diseases or conditions.

Specifically, the bill allows for provisional approval of drugs that are used to treat, prevent, or diagnose a serious or life-threatening disease or condition for which premature death is likely without early medical intervention. The Food and Drug Administration (FDA) must evaluate applications within 90 days of receipt. The FDA may approve applications if there is early evidence, including real-world and real-time evidence, of the drug's efficacy, as well as substantial evidence of the drug's safety. Provisional approval is valid for two years and may be renewed for up to eight years. The FDA may withdraw provisional approval in the event of serious adverse health effects.

Drug sponsors that receive provisional approval must require all patients receiving the drug to participate in an observational registry, through which the drug sponsor may collect and submit data relating to the drug until it is fully approved. Registries may be operated by the drug sponsor or another entity. The FDA must annually review these registries; sponsors of registries that fail to meet the bill's requirements are subject to civil penalties.

Library of Congress summary, Jun 8, 2023

Summary versions
  • Introduced in SenateJun 8, 2023

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