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Congress·In Committee·H.R. 3546

Rep. Khanna Introduces Bill to End Drug Monopolies for Medicines Priced Higher Than in Other Countries

Prescription Drug Price Relief Act of 2025

10 months ago·View on Congress.gov·Read full text

Legislative Progress

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Senate
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Key Points

  • The bill would let the government strip a drug company's exclusive selling rights if the U.S. price is higher than the median price in five other wealthy countries: Canada, the UK, Germany, France, and Japan. This international price comparison is the main test for whether a drug is "excessively" priced.

    From policy text

    “The Secretary shall determine that any brand name drug for which the domestic average manufacturing price exceeds the median price charged for such drug in the 5 reference countries to have an excessive price.”
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  • When a drug is found to be overpriced, the government would immediately void patents and exclusivity protections and issue open licenses so other companies can make cheaper generic or biosimilar versions. Generic makers would pay a reasonable royalty to the original patent holder but must sell below the excessive price.

    From policy text

    “shall waive or void any government-granted exclusivities with respect to such drug, effective on the date that the excessive price determination under section 2 is made for such drug”
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  • Drug companies would be required to submit detailed annual reports on their U.S. and international prices, research and development spending, marketing costs, and global revenues. Companies that fail to report or submit false data face daily fines of 0.5% to 1% of the drug's annual gross revenues.

    From policy text

    “not less than 0.5 percent of the gross revenues from sales for the previous calendar year of the drug for which the information was not submitted”
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  • The FDA would be required to fast-track review of generic drug applications tied to overpriced drugs, acting within 8 months. A public database would track which drugs are deemed excessively priced, how many licenses have been granted, and how many generic applications have been approved.

    From policy text

    “The Secretary shall prioritize the review of, and act within 8 months of the date of the submission of a generic drug application or a biosimilar biological product application if such application references a drug licensed under subsection (a)(2).”
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  • Even if international price data isn't available, the Secretary can still declare a drug excessively priced based on factors like the drug's development costs, government subsidies for its research, the size of the patient population, and whether its price rises faster than inflation.

    From policy text

    “the Secretary shall determine that such drug has an excessive price if the price of the drug is higher than reasonable taking into account the following factors”
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  • Fines collected from noncompliant drug companies would be directed to the National Institutes of Health to support competitive research grants, creating a direct link between drug pricing enforcement and publicly funded medical research.

    From policy text

    “The Secretary shall collect the civil penalties under this subsection and shall use such funds to support competitive research grant programs of the National Institutes of Health.”
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HealthcareEconomy Finance

Impact Analysis

Personal Impact

Scores: 1 = low, 5 = highSentiment: -5 to +5 (net benefit)

Milestones

2 milestones2 actions
May 21, 2025House

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.

May 21, 2025

Introduced in House

What Happens Next

Projected impacts based on AI analysis

Within 30 days of enactment

The Secretary of HHS must set up a system to review all brand-name drug prices and begin comparing them to prices in the five reference countries

This is the first step toward identifying which drugs are overpriced — no prices actually change yet, but the review process begins

By January 15 of the year following enactment

Drug manufacturers must submit their first annual reports detailing U.S. and international prices, R&D costs, and marketing spending

The government gets the pricing data it needs to determine which drugs are excessively priced — companies that don't comply face massive daily fines

Related Bills

1 bill
S. 1818Identical bill

Prescription Drug Price Relief Act of 2025

May 20 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Source Information

Document Type

Congressional Bill

Official Title

Prescription Drug Price Relief Act of 2025

Bill NumberHR 3546
Congress119th Congress
ChamberHouse of Representatives
Latest ActionReferred 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.
Read Full Bill Text

Sponsor

Cosponsors

(4)
D: 4

Analysis generated by AI. Always verify with official sources.