H.R. 9040 — Regulate the Price of All Drugs Act

This section establishes the Prescription Drug Price Regulatory Commission to recommend fair prices for each approved prescription drug to the Secretary of Health and Human Services by the fair price recommendation date, taking into account manufacturer production and distribution costs, cost-effectiveness and therapeutic benefit, anticipated demand, research and development returns, and average prices in comparable reference countries. The Commission consists of 13 members (seven presidential appointees and six ex officio from the Veterans Health Administration, Defense Health Agency, CMS, FDA, CDC, and FTC) serving 4-year terms, operates outside chapter 10 of title 5, and receives necessary appropriations each fiscal year.

This section requires the Secretary of Health and Human Services to establish and publish a fair price for each approved prescription drug by the fair price publication date for the applicable year, taking into account recommendations from the Prescription Drug Price Regulatory Commission. It authorizes the Secretary to revise published prices when necessary to reflect changes in supply, demand, or other factors, and to grant manufacturers temporary 90-day waivers (extendable) to charge higher prices if needed to maintain access for all eligible individuals. Manufacturers that fail to provide access at or below the fair price are subject to a civil penalty equal to 10 times the product of the number of units furnished and the difference between the price charged and the fair price.

This section prohibits selling or offering for sale any drug or biological product at a price exceeding the fair price published under section 3 of the Regulate the Price of All Drugs Act. It treats violations as unfair or deceptive acts or practices under 15 U.S.C. 57a(a)(1)(B), grants the Federal Trade Commission enforcement authority with the same powers and penalties as under the Federal Trade Commission Act, authorizes state attorneys general to bring parens patriae actions for injunctive relief, damages, or other remedies, and creates a private right of action allowing recovery of three times actual damages or $50,000 per violation (whichever is greater), plus attorney fees, with a 5-year statute of limitations from discovery.

This section authorizes the Secretary of Health and Human Services to assert march-in rights and claim a nonexclusive, partially exclusive, or exclusive license on any patent for a drug sold in the United States above the fair price or in quantities insufficient to meet patient demand at that price.

This section authorizes the President to use authorities under titles I, III, and VII of the Defense Production Act of 1950 to increase domestic production of a drug when the Commission determines that United States facilities cannot meet patient demand and foreign supplies cannot be reliably imported at the fair price established under section 3.

This section establishes definitions for the Act, including approved prescription drugs (covering certain prescription drugs, biological products, insulin with associated supplies, and vaccines under the Social Security Act and Public Health Service Act); comparable reference countries (Canada, France, Germany, Italy, Japan, and the United Kingdom); fair price applicability year (beginning in 2027); fair price eligible individual (any individual in the United States when the drug is furnished); and related dates for fair price recommendations and publications.