What does Preamble of Regulate the Price of All Drugs Act do?

This bill is formally titled 'To establish fair prices for prescription drugs, and for other purposes.'

What does SHORT TITLE. of Regulate the Price of All Drugs Act do?

This bill is formally titled the Regulate the Price of All Drugs Act.

What does ESTABLISHING THE PRESCRIPTION DRUG REGULATORY COMMISSION. of Regulate the Price of All Drugs Act do?

This section establishes the Prescription Drug Price Regulatory Commission (Commission). The Commission's primary duty is to recommend fair prices for approved prescription drugs to the Secretary of Health and Human Services. These recommendations must consider factors such as manufacturing costs, cost-effectiveness, anticipated demand, research and development costs, and prices in comparable reference countries. The Commission can recommend revisions to fair prices or temporary waivers under certain circumstances. The Commission will consist of 13 members: seven appointed by the President and six ex officio members from various health agencies. Members are appointed for four-year terms, with potential for a one-year extension. The Commission is not subject to certain provisions of chapter 10 of title 5, United States Code. The legislation authorizes appropriations for the Commission's activities.

What does PUBLICATION OF FAIR PRICES. of Regulate the Price of All Drugs Act do?

This section establishes a process for the Secretary of Health and Human Services to establish and publish 'fair prices' for approved prescription drugs. The Secretary must consider recommendations from the Prescription Drug Price Regulatory Commission when determining fair prices. The Secretary may revise fair prices after the publication date if recommended by the Commission and necessary due to changes in supply, demand, or other factors, providing manufacturers with 30 days' notice. The Secretary can authorize manufacturers to provide drugs at a price exceeding the fair price for up to 90 days (extendable) to maintain access for eligible individuals. Manufacturers failing to provide drugs at or below the fair price (or authorized price) are subject to civil penalties, calculated as 10 times the product of the number of units and the price difference. Section 1128A of the Social Security Act governs the application of civil monetary penalties under this section.

What does FAIR PRICES FOR PRESCRIPTION DRUGS REQUIRED. of Regulate the Price of All Drugs Act do?

This section amends the Federal Food, Drug, and Cosmetic Act to prohibit selling drugs at prices exceeding those published under the Regulate the Price of All Drugs Act. The Federal Trade Commission (FTC) is granted authority to enforce this prohibition, treating violations as violations of the Federal Trade Commission Act. State attorneys general or agencies can bring civil actions on behalf of residents to enjoin violations, seek damages, or obtain other relief. States must provide notice to the FTC before filing an action, and the FTC has the right to intervene. If the FTC or the Attorney General of the United States initiates a federal action, states cannot bring a similar action against the same defendant for the same violation during the federal action's pendency. Individuals injured by violations can bring private actions in federal court to seek injunctive relief and damages, potentially tripled if the violation was willful or knowing. Prevailing plaintiffs in private actions are entitled to recover costs and reasonable attorney's fees.

What does MARCH-IN RIGHTS FOR PATENT. of Regulate the Price of All Drugs Act do?

This section concerns march-in rights for patents related to drugs. If a patent owner sells a drug above the fair price (as defined in section 3) or fails to meet patient demand at that price, the Secretary of Health and Human Services may assert rights. The Secretary can claim a nonexclusive, partially exclusive, or exclusive license for the drug. The terms of any license granted must be reasonable under the circumstances.

What does USE OF THE DEFENSE PRODUCTION ACT. of Regulate the Price of All Drugs Act do?

This section authorizes the President to utilize specific authorities within the Defense Production Act of 1950. The President's authority is contingent on a determination by the Commission. The Commission must find that there are inadequate domestic production facilities and that foreign supplies are unreliable. The purpose is to increase the domestic supply of a drug. The drug's price is established under section 3.

What does DEFINITIONS. of Regulate the Price of All Drugs Act do?

This section defines terms used within the Act. An 'approved prescription drug' includes drugs meeting criteria in section 1927(k)(2) of the Social Security Act, biological products, insulin and associated medical supplies, and vaccines licensed under the Public Health Service Act. ‘Comparable reference country’ includes Canada, France, Germany, Italy, Japan, and the United Kingdom. A 'fair price applicability year' begins with 2027. A 'fair price eligible individual' is an individual located in the United States when the drug is furnished or administered. The 'fair price publication date' is July 1 of the preceding year. The 'fair price recommendation date' is May 1 of the preceding year.

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Regulate the Price of All Drugs Act

Last updated: 5/26/2026 · Introduced: 5/26/2026

Author: Brad Sherman (D-CA)

TL;DR (AI)

This bill establishes a Prescription Drug Price Regulatory Commission to recommend fair prices for approved prescription drugs, considering factors like manufacturing costs and international pricing.
The Secretary of Health and Human Services will publish 'fair prices' for drugs, taking into account the Commission's recommendations and potentially authorizing temporary price increases to ensure access.
It prohibits the sale of prescription drugs at prices exceeding the published 'fair price,' empowering the Federal Trade Commission to enforce this prohibition and allowing states and individuals to pursue legal action for violations.
The bill grants the Secretary of Health and Human Services the authority to assert 'march-in rights' for drug patents if prices are excessive or patient demand isn't met, potentially leading to licensing of the drug.
Under specific circumstances, the President can utilize the Defense Production Act to increase the domestic supply of a drug, contingent on a Commission determination and price established under the Act.

119th Congressin committeeOfficial page

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Includes provisions on preamble, short title., and 6 more.

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