S1818-119

In Committee

Prescription Drug Price Relief Act of 2025

119th Congress Introduced May 20, 2025

Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.

Summary

The Prescription Drug Price Relief Act of 2025 establishes a framework for identifying and addressing excessively priced brand-name drugs in the U.S. by comparing domestic prices to the median price in five reference countries (Canada, UK, Germany, France, Japan). If a drug is found to be excessively priced, the Secretary of HHS can revoke government-granted patent exclusivities and issue open, non-exclusive licenses allowing generic or biosimilar manufacturers to produce the drug, subject to reasonable royalties. The bill also requires annual manufacturer pricing reports, creates a public database of excessive price determinations, mandates expedited FDA review for licensed generics, and authorizes civil actions against manufacturers who raise prices after an excessive-price finding. Public petition rights allow anyone to request a price review.

Evidence Chain:

This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.

At a Glance

What This Bill Does

Lower prescription drug prices by allowing the government to revoke patent exclusivities and grant open licenses for brand-name drugs priced excessively compared to five reference countries (Canada, UK, Germany, France, Japan), with mandatory manufacturer reporting, a public database, and reasonable royalty requirements.

Who Benefits

  • U.S. patients paying high drug prices
  • Generic and biosimilar manufacturers
  • Federal and state purchasers of drugs

Who Bears Costs

  • Brand-name pharmaceutical manufacturers
  • Patent holders

Key Policy Areas

Healthcare, Pharmaceuticals

Primary Purpose

Lower prescription drug prices by allowing the government to revoke patent exclusivities and grant open licenses for brand-name drugs priced excessively compared to five reference countries (Canada, UK, Germany, France, Japan), with mandatory manufacturer reporting, a public database, and reasonable royalty requirements.

Policy Domains

Healthcare Pharmaceuticals

Legislative Strategy

"Use international reference pricing as leverage to revoke patent monopolies for overpriced drugs, creating competitive market pressure without direct price controls"

Legislative Progress

In Committee
Introduced Committee Passed
May 20, 2025

Mr. Sanders (for himself, Mr. Blumenthal, Mr. Booker, Mr. Merkley, …

May 20, 2025

Read twice and referred to the Committee on Health, Education, …

May 20, 2025

Introduced in Senate

Stakeholder Effects

cui bono?

How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.

Pharmaceuticals
8 mentions across 6 clauses
+2 positive -5 negative ?1 uncertain

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

Healthcare
3 mentions across 3 clauses
+3 positive

Consumers and advocacy organizations, Drug purchasers and patients, U.S. drug consumers and patients

Government
3 mentions across 3 clauses
-3 negative

FDA, HHS (data collection), HHS Secretary

6/8
sections analyzed
Full impact breakdown

Key Definitions

Terms defined in this bill

2 terms
"brand name drug" §8

Drug approved under 505(c) of FFDCA or 351(a) of PHS Act

"reference countries" §2(b)(1)(B)

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