This bill caps U.S. prescription drug prices by requiring that medications and biological products cannot cost more in America than the average price charged in six wealthy nations: Canada, France, Germany, Italy, Japan, and the United Kingdom. The legislation applies to all drugs and biologics approved by the FDA and affects pharmaceutical manufacturers, who must submit annual pricing data from these countries to the Department of Health and Human Services. Manufacturers that violate the price cap face civil penalties equal to 10 times the difference between the U.S. price and the international average, calculated for each unit sold. The Health and Human Services Secretary must calculate the international average prices annually using manufacturer-reported data and publicly available pricing information, and is required to issue guidance and regulations to enforce these provisions. The bill does not specify a funding amount or implementation timeline beyond the annual calculation requirement.
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