What does Preamble of Prescription Drug Price Relief Act of 2025 do?

This bill, formally titled 'To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries,' aims to reduce prescription drug costs. The bill intends to achieve this by eliminating government-granted monopolies for drug manufacturers. The bill targets manufacturers who charge prices exceeding the median prices observed in other countries.

What does SHORT TITLE. of Prescription Drug Price Relief Act of 2025 do?

This bill is formally titled the Prescription Drug Price Relief Act of 2025.

What does IDENTIFICATION OF EXCESSIVELY PRICED DRUGS. of Prescription Drug Price Relief Act of 2025 do?

This section establishes a process for the Secretary to identify excessively priced brand name drugs. The Secretary must establish this process within 30 days of the Act's enactment and conduct reviews at least once per calendar year. A drug's price is considered excessive if the domestic average manufacturing price exceeds the median price charged in Canada, the United Kingdom, Germany, France, and Japan. If data is insufficient to make a determination based on international reference prices, the Secretary will consider factors such as patient population size, therapeutic value, government subsidies, development costs, and health outcome improvements. Individuals can petition the Secretary to make an excessive drug price determination, and the Secretary must respond within 90 days. The Secretary can decline to make a determination but must publicly explain the reasons for doing so. Petitions, documentation, and the Secretary's determinations will be made publicly available.

What does ENDING GOVERNMENT-GRANTED MONOPOLIES FOR EXCESSIVELY PRICED of Prescription Drug Price Relief Act of 2025 do?

This section outlines procedures to address excessively priced brand name drugs. If the Secretary determines a drug's price is excessive, government-granted exclusivities will be waived or voided. Open, non-exclusive licenses will be granted allowing others to manufacture, use, sell, or import the drug, referencing section 4. The Secretary will prioritize review of generic drug applications referencing drugs licensed under this section, acting within 8 months. If a manufacturer increases the price of an excessively priced drug after the price determination and before another entity begins manufacturing under a license, the Secretary may file a civil action to recover damages. Damages recovered will be at least equal to the revenue derived from the price increase.

What does EXCESSIVE DRUG PRICE LICENSE. of Prescription Drug Price Relief Act of 2025 do?

This section establishes an 'Excessive Drug Price License' related to entities accepting licenses under section 3(a)(2). Entities receiving such licenses must pay a reasonable royalty to patent holders or application holders for drugs with terminated government-granted exclusivity under section 3(a)(1). The royalty rate can be a percentage of sales, not exceeding the average royalty rate from pharmaceutical manufacturer IRS data, or an amount determined by the Secretary. The Secretary will consider factors like drug value to patients, patient population size, government subsidies, health outcome improvements, and manufacturer investment recovery when determining the royalty amount. Royalty rates must ensure drugs are available at affordable and reasonable prices and cannot result in 'excessive prices' as defined in section 2. If multiple holders or investors exist, the royalty rate is divided among them, either by agreement or as determined by the Secretary. Entities accepting the license must sell the drug at a price below the excessive price determined under section 2(b).

What does PUBLIC EXCESSIVE DRUG PRICE DATABASE. of Prescription Drug Price Relief Act of 2025 do?

This section establishes a 'Public Excessive Drug Price Database' to be maintained by the Secretary. The database will contain information on brand name drugs, including whether they have been determined to have excessive prices under section 2. Required database contents include drug name, manufacturer, excessive price determinations, petition numbers, license information, and application data related to generic and biosimilar versions. The Secretary must publish excessive price determinations within 30 days of receiving pricing information. The Secretary must submit an annual report to Congress summarizing excessive drug price reviews, including data on reviewed drugs, excessively priced drugs, license grants, application approvals, and petition numbers. The report will also include information on manufacturers who failed to report required information. The database and annual report must be made publicly available, including on the Food and Drug Administration website.

What does DRUG MANUFACTURER REPORTING. of Prescription Drug Price Relief Act of 2025 do?

This section mandates that drug manufacturers submit annual reports to the Secretary. The reports must include information on average manufacturer price, wholesale acquisition cost, global revenues, and net sales revenue for each brand name drug, broken down quarterly. Manufacturers must also report expenditures on research and development, marketing and advertising, and investments in human clinical trials. The reports must include the estimated size of the affected patient population and additional information related to pricing decisions. The Secretary can require additional information deemed necessary to carry out the Act. Reports are due by January 15 of the year following enactment and each year thereafter. Manufacturers failing to submit information or providing false information are liable for civil monetary penalties. The penalty amount is based on a percentage of the drug's gross revenues and the number of days the report is late. Civil penalties collected will be used to support competitive research grant programs of the National Institutes of Health.

What does PROHIBITION OF ANTICOMPETITIVE BEHAVIOR. of Prescription Drug Price Relief Act of 2025 do?

This section prohibits manufacturers from engaging in anticompetitive behavior. Such behavior must violate section 5(a) of the Federal Trade Commission Act. The prohibited behavior involves interference with open, non-exclusive licenses under this Act. The prohibition also applies to behavior running contrary to the public interest in affordable prescription drugs.

What does DEFINITIONS. of Prescription Drug Price Relief Act of 2025 do?

This section defines terms used throughout the Act. “Average manufacturer price” is defined based on section 1927(k)(1) of the Social Security Act, or the wholesale acquisition cost if no AMP exists. A “biosimilar biological product” is defined as a biological product licensed under section 351(k) of the Public Health Service Act. “Brand name drug” includes drugs approved under specific sections of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, subject to section 353(b)(1) of the FD&C Act, and claimed in a patent. “Generic drug” is defined as a drug approved under sections (b)(2) or (j) of the Federal Food, Drug, and Cosmetic Act. “Government-granted exclusivity” refers to prohibitions on drug application submissions or approvals granted under various provisions of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. “Manufacturer” is defined as the holder of an application approved under section 505 of the FD&C Act or a license issued under section 351 of the Public Health Service Act. An “open, non-exclusive license” authorizes any person to use a patent held by a manufacturer. “Secretary” refers to the Secretary of Health and Human Services.

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Prescription Drug Price Relief Act of 2025

Last updated: 5/20/2025 · Introduced: 5/20/2025

Author: Bernie Sanders (I-VT)

TL;DR (AI)

This bill establishes a process for the Secretary of Health and Human Services to identify brand name drugs with excessively high prices, comparing them to median prices in other developed countries.
If a drug is deemed excessively priced, the bill waives or voids government-granted exclusivities, allowing other manufacturers to produce and sell the drug.
Manufacturers granted licenses to produce these drugs must pay a reasonable royalty to patent holders and sell the drug at a price below the excessive price determination.
Drug manufacturers are required to submit annual reports detailing pricing information, research and development costs, and other relevant data to the Secretary.
The bill prohibits manufacturers from engaging in anticompetitive behavior that interferes with the licensing process or hinders access to affordable prescription drugs.

119th Congressin committeeHR. 3546(In Committee)Official page

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