Prescription Drug Price Relief Act of 2025
Summary
What This Bill Does
The bill requires annual review process to identify brand-name drugs with excessive prices using international reference pricing and multi-factor assessment, requires revocation of patent exclusivities and granting of open non-exclusive licenses for excessively priced drugs, and creates reasonable royalty framework for open licenses, with rate caps and affordability requirements. It relies on reporting requirements, price controls, compliance mandates, and exemptions. The main policy areas are Healthcare.
Who Benefits and How
Generic and biosimilar manufacturers could face fewer barriers, U.S. drug consumers and patients could see lower costs, and Drug purchasers and patients could see lower costs.
Who Bears the Burden and How
Brand-name drug manufacturers would take on compliance duties, Brand-name pharmaceutical manufacturers could lose revenue opportunities, and Brand-name drug patent holders could lose revenue opportunities.
Key Provisions
- Requires annual review process to identify brand-name drugs with excessive prices using international reference pricing and multi-factor assessment.
- Requires revocation of patent exclusivities and granting of open non-exclusive licenses for excessively priced drugs.
- Creates reasonable royalty framework for open licenses, with rate caps and affordability requirements.
- Requires public database of excessive drug price determinations with manufacturer and pricing data.
- Requires mandatory annual manufacturer reporting of drug prices in U.S. and reference countries, R&D costs, and marketing expenditures.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
The bill requires annual review process to identify brand-name drugs with excessive prices using international reference pricing and multi-factor assessment, requires revocation of patent exclusivities and granting of open non-exclusive licenses for excessively priced drugs, and creates reasonable royalty framework for open licenses, with rate caps and affordability requirements.
Key Policy Areas
Healthcare
Primary Purpose
The bill requires annual review process to identify brand-name drugs with excessive prices using international reference pricing and multi-factor assessment, requires revocation of patent exclusivities and granting of open non-exclusive licenses for excessively priced drugs, and creates reasonable royalty framework for open licenses, with rate caps and affordability requirements.
Policy Domains
Whole bill
Identified Gains
- Generic and biosimilar manufacturers
- U.S. drug consumers and patients
- Drug purchasers and patients
- Generic licensees
- Consumers and advocacy organizations
Identified Costs
- Brand-name drug manufacturers
- Brand-name pharmaceutical manufacturers
- Brand-name drug patent holders
- Patent holders receiving royalties
- HHS Secretary
Sponsors
Legislative Progress
In CommitteeMr. Sanders (for himself, Mr. Blumenthal, Mr. Booker, Mr. Merkley, …
Read twice and referred to the Committee on Health, Education, …
Introduced in Senate
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Brand-name drug manufacturers, Brand-name drug patent holders, Brand-name pharmaceutical manufacturers
Positive-direction: Generic and biosimilar manufacturers, Generic licensees
Negative-direction: Brand-name drug manufacturers, Brand-name drug patent holders, Brand-name pharmaceutical manufacturers, Patent holders receiving royalties
Consumers and advocacy organizations, Drug purchasers and patients, U.S. drug consumers and patients
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
Key Definitions
Terms defined in this bill
Drug approved under 505(c) of FFDCA or 351(a) of PHS Act
Canada, United Kingdom, Germany, France, and Japan
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology