Judiciary Committee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
The Prescription Drug Price Relief Act of 2025 seeks to reduce prescription drug costs in the United States by targeting brand name drugs with **excessive prices**. The Secretary of Health and Human Services is mandated to establish a process for annual review of all brand name drugs to determine if their prices are excessive. A drug is primarily deemed excessively priced if its domestic average manufacturing price exceeds the median price charged in Canada, the United Kingdom, Germany, France, and Japan. For drugs not identified as excessive through international comparison, or when insufficient data exists, the Secretary can still determine an excessive price based on factors such as patient population size, the drug's value and impact on access, Federal Government subsidies, development costs, and whether the drug significantly improved health outcomes. Any person may also petition the Secretary to make an excessive price determination for a drug, with the Secretary required to respond within 90 days. If a drug is determined to have an excessive price, the Secretary must **waive or void any government-granted exclusivities** for that drug and grant **open, non-exclusive licenses** to allow other entities to manufacture, sell, or import it. These licensees would pay a reasonable royalty to the original patent holder, determined as a percentage of sales or by the Secretary based on factors like patient value and government investment. Crucially, any drug sold under such a license must be priced below the determined excessive price. The bill also requires the Secretary to establish a public database detailing excessive price determinations and related licensing activities, and to submit annual reports to Congress. Drug manufacturers are mandated to submit annual reports on pricing, revenue, and research expenditures, with penalties for non-compliance. Furthermore, the bill prohibits anticompetitive behavior that could interfere with the implementation of these open licenses.
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.
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.
The Prescription Drug Price Relief Act of 2025 seeks to reduce prescription drug costs in the United States by targeting brand name drugs with **excessive prices**. The Secretary of Health and Human Services is mandated to establish a process for annual review of all brand name drugs to determine if their prices are excessive. A drug is primarily deemed excessively priced if its domestic average manufacturing price exceeds the median price charged in Canada, the United Kingdom, Germany, France, and Japan. For drugs not identified as excessive through international comparison, or when insufficient data exists, the Secretary can still determine an excessive price based on factors such as patient population size, the drug's value and impact on access, Federal Government subsidies, development costs, and whether the drug significantly improved health outcomes. Any person may also petition the Secretary to make an excessive price determination for a drug, with the Secretary required to respond within 90 days. If a drug is determined to have an excessive price, the Secretary must **waive or void any government-granted exclusivities** for that drug and grant **open, non-exclusive licenses** to allow other entities to manufacture, sell, or import it. These licensees would pay a reasonable royalty to the original patent holder, determined as a percentage of sales or by the Secretary based on factors like patient value and government investment. Crucially, any drug sold under such a license must be priced below the determined excessive price. The bill also requires the Secretary to establish a public database detailing excessive price determinations and related licensing activities, and to submit annual reports to Congress. Drug manufacturers are mandated to submit annual reports on pricing, revenue, and research expenditures, with penalties for non-compliance. Furthermore, the bill prohibits anticompetitive behavior that could interfere with the implementation of these open licenses.
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.
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.