This bill establishes a new Bureau of Prescription Drug Affordability and Access within the Department of Health and Human Services to review and regulate drug prices. The bureau would require pharmaceutical manufacturers to submit detailed information about their drugs' development costs, pricing in other countries, and revenue projections, and would conduct annual reviews of drug prices to determine if they are "appropriate." If a manufacturer's price is deemed inappropriate, the bureau can order price reductions and require the company to refund excess profits to affected patients.
The bill sets an interim price cap for existing brand-name drugs at the median price charged in ten other developed countries including Canada, the United Kingdom, and Australia. If manufacturers refuse to comply with price determinations within 30 days, the government can authorize competitors to manufacture the drug or establish public manufacturing facilities. Manufacturers who fail to meet interim price caps face civil penalties of at least 150 percent of excess revenues, with the money going to the National Institutes of Health.
The bill funds the new bureau with $50 million annually and requires it to hold regular public meetings and establish a Consumer Advisory Council composed primarily of patients. It also repeals Medicare's current restriction on negotiating drug prices directly. Senators Cory Booker and Bernie Sanders introduced the legislation in July 2024.
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