Legislation1w ago
42
To authorize implementation grants to community-based nonprofits to operate one-stop reentry centers.
HR8548Rep. Kamlager-Dove, Sydney [D-CA-37] (D-CA)
introduced
S1818119th CongressWALLET
Prescription Drug Price Relief Act of 2025
Sponsored By: Senator Sen. Sanders, Bernard [I-VT]
Introduced
Summary
Voids government-granted exclusivities and creates open non-exclusive licenses to push down high drug prices. The bill would direct the Secretary to review brand-name drugs at least annually using an international reference-price test across five countries and a factors-based test to flag excessive prices. If a drug is found excessive the bill would void exclusivities and require open licenses that let others make, sell, or import the drug under a reasonable royalty.
Show full summary
- Families and patients: Licensed versions must be sold below the excessive price, which could expand access and lower costs for people who need these drugs.
- Brand-name manufacturers: Could lose monopolies and face royalty limits based on IRS-derived averages or Secretary determinations. Courts could also require repayment of revenue from price increases after an excessive-price finding.
- Generic and biosimilar developers: Would get an expedited eight-month review for applications that reference a newly licensed drug and public access to pricing, petition, and licensing details via a required database.
Your PRIA Score
Score Hidden
Personalized for You
How does this bill affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this bill and every other piece of legislation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Bill Overview
Analyzed Economic Effects
4 provisions identified: 2 benefits, 1 costs, 1 mixed.
End exclusivity and open drug licenses
If enacted, HHS would void government-granted exclusivities for any brand drug it finds excessively priced on the determination date. HHS would grant open, non-exclusive licenses so any person could make, import, or sell the drug and rely on its regulatory data. If a maker raises prices after the excessive-price finding and before another firm begins making the drug, HHS could sue to recover at least the extra revenue from that price jump. The bill would also bar anticompetitive conduct that blocks these licensing steps.
Annual drug price reviews and reporting
If enacted, HHS would set up a review process within 30 days and review every brand-name drug at least once a year. HHS would use an international price test comparing U.S. prices to Canada, the UK, Germany, France, and Japan when prices exist in at least three of those countries. Drugs not covered by that test would be judged using listed factors like patient impact, federal subsidies, and R&D. Any person could petition HHS; petition decisions would be due within 90 days and limited to one petition per drug each year. HHS would publish determinations and keep a public database and report to Congress within 60 days after the first review and then yearly.
Manufacturer reporting and late penalties
If enacted, manufacturers would file an annual report by January 15 with detailed per-drug data on U.S. and reference-country prices, sales, R&D, marketing, trial investments, and affected patient population. Late or false reports would trigger civil penalties. Penalties would equal between 0.5% and 1% of the prior-year gross revenues for the drug, prorated daily by days late, and collected funds would go to NIH competitive research grants.
Royalties and fast FDA reviews
If enacted, companies that accept an open license would have to pay a royalty to the prior patent or approval holders. The royalty would be either no higher than an industry-average rate from IRS data or an amount HHS sets after weighing factors like patient value and federal subsidies. Royalties must be set so licensed products sell below the excessive price. HHS would also prioritize and complete FDA review of generics or biosimilars that reference a licensed drug within eight months of application.
Free Policy Watch
You just read the policy. Now see what it costs you.
Pick a topic. PRIA runs your household against live legislation and sends you a free personalized readout.
Pick a topic to get started
Sponsors & CoSponsors
Sponsor
Sen. Sanders, Bernard [I-VT]
VT • I
Cosponsors
Richard Blumenthal
CT • D
Sponsored 5/20/2025
Sen. Booker, Cory A. [D-NJ]
NJ • D
Sponsored 5/20/2025
Sen. Merkley, Jeff [D-OR]
OR • D
Sponsored 5/20/2025
Sen. Murphy, Christopher [D-CT]
CT • D
Sponsored 5/20/2025
Peter Welch
VT • D
Sponsored 5/20/2025
Sen. Warren, Elizabeth [D-MA]
MA • D
Sponsored 5/20/2025
Sen. Whitehouse, Sheldon [D-RI]
RI • D
Sponsored 6/17/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.govTake It Personal
Get Your Personalized Policy View
Take the PRIA Score to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in