Prescription Drug Price Relief Act of 2025

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Votes

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