The Prescription Drug Price Relief Act of 2025 seeks to significantly reduce prescription drug costs for patients in the United States. It proposes to achieve this by ending government-granted monopolies for manufacturers who charge excessively high prices for their brand name drugs. The Secretary of Health and Human Services would establish a process to review all brand name drugs annually to determine if their prices are excessive. A drug's price is deemed excessive if its domestic average manufacturing price exceeds the median price in five reference countries: Canada, the United Kingdom, Germany, France, and Japan. Even if international data is insufficient, a drug can be deemed excessively priced if its cost is higher than reasonable, considering factors such as the affected patient population, therapeutic value, federal government subsidies, development costs, health outcome improvements, global revenues, and price increases relative to inflation. The public can also petition the Secretary to make an excessive price determination for a drug. If a drug is determined to have an excessive price, the Secretary must waive or void any government-granted exclusivities for that drug. Concurrently, the Secretary would grant open, non-exclusive licenses, allowing any person to manufacture, sell, or import generic or biosimilar versions of the drug, relying on the original regulatory test data. Applications for these generic or biosimilar products would receive expedited review, with a decision required within eight months. Entities accepting these open, non-exclusive licenses would pay a reasonable royalty to the original patent holder, determined either as a percentage of sales based on industry averages or by the Secretary considering factors like the drug's value to patients and federal investments. Crucially, the royalty rate must ensure that the licensed drug is sold at an affordable and reasonable price, below the original excessive price. Manufacturers who increase prices after an excessive price determination could face civil actions to recover damages. To ensure transparency, the bill mandates the creation of a public database detailing excessively priced drugs, the number of licenses granted, and application statuses. Manufacturers would be required to submit annual reports containing detailed pricing, revenue, research and development, and marketing expenditure data. Failure to comply with reporting requirements or providing false information would result in significant civil monetary penalties, with collected funds supporting National Institutes of Health research. The bill also prohibits anticompetitive behavior that could interfere with the implementation of these licenses.
The Prescription Drug Price Relief Act of 2025 seeks to significantly reduce prescription drug costs for patients in the United States. It proposes to achieve this by ending government-granted monopolies for manufacturers who charge excessively high prices for their brand name drugs. The Secretary of Health and Human Services would establish a process to review all brand name drugs annually to determine if their prices are excessive. A drug's price is deemed excessive if its domestic average manufacturing price exceeds the median price in five reference countries: Canada, the United Kingdom, Germany, France, and Japan. Even if international data is insufficient, a drug can be deemed excessively priced if its cost is higher than reasonable, considering factors such as the affected patient population, therapeutic value, federal government subsidies, development costs, health outcome improvements, global revenues, and price increases relative to inflation. The public can also petition the Secretary to make an excessive price determination for a drug. If a drug is determined to have an excessive price, the Secretary must waive or void any government-granted exclusivities for that drug. Concurrently, the Secretary would grant open, non-exclusive licenses, allowing any person to manufacture, sell, or import generic or biosimilar versions of the drug, relying on the original regulatory test data. Applications for these generic or biosimilar products would receive expedited review, with a decision required within eight months. Entities accepting these open, non-exclusive licenses would pay a reasonable royalty to the original patent holder, determined either as a percentage of sales based on industry averages or by the Secretary considering factors like the drug's value to patients and federal investments. Crucially, the royalty rate must ensure that the licensed drug is sold at an affordable and reasonable price, below the original excessive price. Manufacturers who increase prices after an excessive price determination could face civil actions to recover damages. To ensure transparency, the bill mandates the creation of a public database detailing excessively priced drugs, the number of licenses granted, and application statuses. Manufacturers would be required to submit annual reports containing detailed pricing, revenue, research and development, and marketing expenditure data. Failure to comply with reporting requirements or providing false information would result in significant civil monetary penalties, with collected funds supporting National Institutes of Health research. The bill also prohibits anticompetitive behavior that could interfere with the implementation of these licenses.