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 proposes achieving this by eliminating government-granted monopolies for drug manufacturers. It targets manufacturers who charge prices exceeding the median prices found 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 compare to international prices, the Secretary will consider factors like patient population size, therapeutic benefits, government subsidies, development costs, and revenue when determining if a price is excessive. Any person can petition the Secretary to make an excessive drug price determination, and the Secretary must respond within 90 days. The Secretary can decline a determination but must publicly explain the reasons. The Secretary will make petitions, documentation, determinations, and rationale 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 and rely on regulatory test data. The Secretary will prioritize review of generic drug applications referencing drugs licensed under this section, acting within 8 months. The Secretary may file a civil action to recover damages if a manufacturer increases the price of an excessively priced drug after the initial determination and before another entity begins manufacturing under a license. District courts have jurisdiction to grant injunctive relief and compensatory damages in such civil actions.

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 the drug's value to patients, patient population size, government subsidies, health outcome improvements, and manufacturer's 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 determined under section 2. If multiple holders or investors exist, the royalty rate is divided among them through agreement or by the Secretary's determination. 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 database of brand name drugs and excessive price determinations. The database will include information such as drug name, manufacturer, excessive price determinations, petitions received, and licenses granted for generic versions. The Secretary must publish excessive price determinations within 30 days of receiving pricing information. The Secretary is required to submit an annual report to Congress summarizing excessive drug price reviews. The report will contain data on the number of drugs reviewed, those deemed excessively priced, license grants, and application approvals for generic versions. The Secretary must make the database and annual report publicly available 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 detailed information about each brand name drug, covering the previous calendar year. Required data includes average manufacturer price, wholesale acquisition cost, global revenues, and net sales revenue, broken down quarterly. Manufacturers must also report expenditures on research and development, marketing and advertising, and human clinical trials, with specific breakdowns. The report must also include the estimated size of the affected patient population. Manufacturers can provide additional information related to drug pricing decisions. The Secretary can request additional information deemed necessary. Reports are due by January 15 of the year following enactment and each year thereafter. Failure to submit information or providing false information results in a civil monetary penalty. The penalty is calculated based on a percentage of gross revenues and the number of days of noncompliance, with a minimum of 0.5% and a maximum of 1%.

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 (15 U.S.C. 45(a)). The prohibited behavior relates to actions that interfere with the issuance and implementation of open, non-exclusive licenses under this Act. Actions contrary to the public interest in the availability of affordable prescription drugs are also prohibited.

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. A “brand name drug” is defined based on approval under specific sections of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, subject to section 503(b)(1) of the FD&C Act, and claimed in a patent. A “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 sections 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 or rely upon regulatory test data for a brand name drug. “Secretary” refers to the Secretary of Health and Human Services.

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Prescription Drug Price Relief Act of 2025

Last updated: 5/21/2025 · Introduced: 5/21/2025

Author: Ro Khanna (D-CA)

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 for the manufacture, use, sale, and import of the drug by others.
Manufacturers accepting licenses to produce these drugs must pay a royalty to patent holders, with the royalty rate determined by the Secretary and capped based on existing IRS data.
Drug manufacturers are required to submit annual reports detailing pricing information, research and development expenditures, and patient population data.
The bill prohibits anticompetitive behavior by manufacturers that interferes with the licensing process or hinders the availability of affordable prescription drugs.

119th Congressin committeeS. 1818(In Committee)Official page

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