H.R. 3546: Prescription Drug Price Relief Act of 2025

This bill, known as the Prescription Drug Price Relief Act of 2025, aims to reduce the costs of prescription drugs in the United States by removing government protections for pharmaceutical companies that charge excessive prices. Here’s a breakdown of what the bill proposes:

Identification of Excessively Priced Drugs

The bill mandates that the Secretary of Health and Human Services establish a process to review brand name drugs annually. This review will help determine if their prices are excessively high compared to the median prices charged in five reference countries: Canada, the United Kingdom, Germany, France, and Japan.

• If a drug’s average manufacturing price in the U.S. is higher than the median price in these countries, it will be categorized as excessively priced.
• Even if a drug doesn’t get flagged by this initial comparison, the Secretary may still designate it as excessively priced based on other criteria, which include factors such as patient population size, the drug's health benefits, and development costs.

Ending Government-Granted Monopolies

If the Secretary classifies a drug as excessively priced, the bill allows the Secretary to:

• Waive any government-granted exclusivity rights for that drug, which typically prevents market competition.
• Issue open, non-exclusive licenses to allow other manufacturers to produce and sell the drug, facilitating the entry of generic alternatives.

Expedited Reviews for Generic Drugs

The Secretary is required to expedite the review process for applications to produce generic or biosimilar versions of drugs deemed excessively priced, aiming to process these applications within eight months.

Reporting Requirements for Drug Manufacturers

Drug manufacturers will be required to submit annual reports detailing:

• The average and wholesale prices of their drugs in both the United States and reference countries.
• Their cumulative global revenue and expenditures on related research and development.
• Penalties will be imposed on manufacturers for failing to comply with these reporting requirements.

Public Database and Transparency

The bill introduces the establishment of a public database that documents all brand name drugs, prices deemed excessive, and related manufacturer information. This database will promote transparency and allow the public and stakeholders to access this information easily.

Prohibition of Anticompetitive Behavior

The legislation also prevents manufacturers from engaging in anticompetitive practices that could obstruct the approval and implementation of new licenses for drug production, ensuring that competition is encouraged in the pharmaceutical market.

Annual Reporting to Congress

The Secretary will be responsible for providing annual reports to Congress with data on reviewed drugs, excessive pricing determinations, and the overall outcomes related to the bill's implementations.

Definitions

The bill includes various definitions related to terms such as "average manufacturer price," "brand name drug," "generic drug," and "open, non-exclusive license," which lay out the framework within which the bill operates.

Implementation Timeline

The Secretary must publish their findings from the price reviews and petitions within certain time frames to ensure timely public access to information regarding drug pricing.

Relevant Companies

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