Regulate the Price of All Drugs Act
HB9040, titled the Regulate the Price of All Drugs Act, would create a federal prescription drug pricing regime centered on a new Prescription Drug Price Regulatory Commission and a mandatory “fair price” published by the Secretary of Health and Human Services for each approved prescription drug. The bill covers prescription drugs, biologics, insulin and related supplies, and vaccines, and it would require manufacturers to make those products available at or below the published fair price to eligible individuals in the United States, as well as to hospitals, physicians, pharmacies, mail-order services, and other dispensers or suppliers serving those individuals.
The Commission would be a 13-member body with presidential appointees and ex officio members from HHS-related agencies, and it would recommend fair prices using factors such as production and distribution costs, therapeutic benefit and cost-effectiveness, demand, research and development costs, return on investment, and international reference prices in countries such as Canada, France, Germany, Italy, Japan, and the United Kingdom. The Secretary could revise prices, grant temporary waivers to preserve access, and rely on the Commission’s recommendations, while manufacturers that charge above the fair price would face civil penalties. The bill also adds a new prohibition to the Federal Food, Drug, and Cosmetic Act against selling drugs above the published fair price, authorizes FTC enforcement, allows state attorneys general and private plaintiffs to sue, and creates a five-year limitations period for private actions.
If enacted, the bill would significantly expand federal control over prescription drug pricing by amending the Federal Food, Drug, and Cosmetic Act and creating new enforcement mechanisms under the FTC Act. It would also give HHS authority to set and publish binding prices, impose civil penalties on manufacturers, and potentially use march-in rights to obtain patent licenses when drugs are sold above the fair price or supplied in inadequate quantities. In addition, the bill would authorize the President to use Defense Production Act authorities to increase domestic supply when production or import capacity is insufficient to support the fair price system. The affected parties would include drug and biologic manufacturers, pharmacies, hospitals, physicians, insurers and patients, as well as federal and state enforcement agencies.
No committee transcript or vote history was provided, so there is no recorded floor or committee sentiment to summarize. Based on the bill text alone, the measure appears strongly pro-consumer and aimed at lowering drug costs, with an assertive regulatory approach that suggests support from advocates of price controls and opposition likely from pharmaceutical industry stakeholders and others concerned about government price-setting. The inclusion of waivers, revision authority, and supply-related safeguards indicates an effort to balance affordability with access.
The main points of contention are likely to be the federal government’s authority to set mandatory drug prices, the use of international reference pricing, and the bill’s enforcement structure, including civil penalties, FTC oversight, state enforcement, and private rights of action. Pharmaceutical manufacturers would likely object to the bill’s impact on revenue, innovation incentives, and patent rights, especially the march-in license provision and the possibility of penalties for noncompliance. Supporters would likely emphasize affordability, patient access, and the bill’s mechanisms for preventing shortages through waivers and Defense Production Act use. The bill’s reliance on cost-effectiveness measures such as quality-adjusted life years may also draw debate from patient advocates and disability rights groups.