Prescription Drug Price Relief Act of 2025
The Prescription Drug Price Relief Act of 2025 aims to lower U.S. prescription drug costs by targeting drugs it deems excessively priced and dismantling government-granted monopolies on those drugs. The bill creates a process to identify brand-name drugs whose domestic prices exceed the median price in five reference countries (Canada, the United Kingdom, Germany, France, and Japan). If a drug is deemed excessive, the government would void exclusivities that protect the brand-name drug and issue open, non-exclusive licenses to allow others to manufacture and sell the drug in the United States, with the condition that royalty payments are made to patent or data holders. An expedited path for generics/biosimilars would be available, and there are civil actions and penalties intended to discourage price increases during the transition. The proposal also requires manufacturers to report detailed pricing and development information to a public database and to Congress, with penalties for noncompliance. Overall, the bill seeks to rapidly introduce competition for overpriced drugs to lower patient costs, while providing a structured framework for royalties to patent holders and for monitoring and transparency.
Key Points
- 1Identify excessively priced drugs using international reference pricing and other factors
- 2- Within 30 days of enactment, the Secretary must set up a review process. A drug is considered excessive if its domestic price exceeds the median price in the reference countries, assessed against listed factors. If data from at least 3 of the 5 reference countries exist, a determination can be made; if not, the Secretary uses additional factors (patient population size, drug value, development costs, health outcomes, global revenues, and inflation-relative price changes) to decide.
- 3End government-granted monopolies and open the market to competition for excessive drugs
- 4- For drugs found excessive, the Secretary would void government-granted exclusivities and grant open, non-exclusive licenses allowing any entity to manufacture, import, and sell the drug in the U.S., relying on the drug’s regulatory test data. An expedited review path would push the approval process for generics/biosimilars referencing the drug to about 8 months.
- 5Royalty framework and price controls under open licenses
- 6- Entities that obtain an open license would pay a reasonable royalty to patent/data holders. The royalty could be set as a percentage of sales (based on IRS data) or determined by the Secretary using factors like patient value, affected population size, government subsidies, development costs, and health outcomes. The royalty must not enable prices that are themselves excessive, and royalties would be shared among multiple holders if applicable. Licensed drugs must be sold below the excessive-price threshold.
- 7Public database and transparency
- 8- A public Excessive Drug Price Database would track drug name, manufacturer, excessive-price determinations, petitions, open licenses issued, and license-related approvals. The Secretary would publish determinations and related data within set timelines, and Congress would receive annual reports with detailed metrics on reviews, price differentials, licensing, and petition activity.
- 9Manufacturer reporting and penalties
- 10- Drug manufacturers must annually report pricing, revenues, development expenditures, trial investments, and other pricing-related information, due by January 15 each year. Noncompliance or knowingly false reporting would incur civil penalties (a percentage of the drug’s gross revenues and days late), with funds used to support NIH competitive research grants.
- 11Anticompetitive behavior and definitions
- 12- The bill prohibits anti-competitive actions that would interfere with open licenses or undermine affordable drug availability. It also provides definitions for key terms (brand-name drug, generic drug, biosimilar, government-granted exclusivity, open license, etc.).