H.R. 3546 · Where this bill is now
In committee
Introduced in the House, sent to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned, May 21, 2025
What this bill does
In plain words · AI-written from the official summaryAllows HHS to void drug exclusivity for pricing
Here's the gist: the bill asks the Department of Health and Human Services to check brand-name drug prices every year to see if they're too high. If HHS decides a drug costs too much, it can cancel the special legal protections that usually give a drug company exclusive rights to sell that drug. When that happens, other companies can make and sell generic versions or biosimilar products at lower prices.
How it affects you
If you take brand-name prescription drugs, this could lower your out-of-pocket costs if HHS determines your medication is priced excessively and allows generic or biosimilar alternatives to reach the market. People who struggle to afford their medications might have more affordable options available.
Read the official summary (Introduced in House, May 21, 2025)
Prescription Drug Price Relief Act of 2025
This bill requires the Department of Health and Human Services (HHS) to review brand-name drugs annually for excessive pricing and, if a drug is found to be priced excessively, to void any exclusivity granted to its sponsor.
Specifically, HHS must review all brand-name drug prices at least annually and upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug.
An entity accepting an open, nonexclusive license under these provisions must pay a reasonable royalty to the holder of the relevant patent or approved new drug application, and must price the generic drug or biosimilar below the excessive rate.
Under the bill, a price is considered excessive if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of these countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including development cost, revenue, and the size of the affected patient population.
The bill also requires drug manufacturers to report specified financial information for brand-name drugs, including research and advertising expenditures.
Written by AI (Claude) using only the official summary by the Congressional Research Service, the Library of Congress’s nonpartisan research staff. It can miss nuance, so check the official summary and the bill text for details.
1st SessionH. R. 3546
A BILL
Prescription Drug Price Relief Act of 2025
Sponsor: Rep. Ro Khanna (D-CA-17) · Introduced May 21, 2025 · Health · 1 version of the text
Sources: Congress.gov actions and votes · bill text from GovInfo · latest official action May 21, 2025: “Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.”
Sections
Sections · 8
- Sec. 1Short titleNo change
- Sec. 2Identification of excessively priced drugsNo change
- Sec. 3Ending government-granted monopolies for excessively priced drugsNo change
- Sec. 4Excessive drug price licenseNo change
- Sec. 5Public excessive drug price databaseNo change
- Sec. 6Drug manufacturer reportingNo change
- Sec. 7Prohibition of anticompetitive behaviorNo change
- Sec. 8DefinitionsNo change