Authorizes the collection of supplemental payments to enhance congressional investments in medical research.
Defines “covered blockbuster drug” as a drug with over $1 billion in net sales that was developed with federal government investment.
Establishes criteria for assessing supplemental payments from “covered manufacturers” that have entered into specific settlement agreements and reported significant net income.
Sets the payment amount based on a percentage of the manufacturer’s net income, with varying rates depending on the size of the settlement agreement.
Requires the Secretary to publish a list of manufacturers, their drugs, and payment amounts annually.
Ensures that collected payments supplement, rather than replace, existing federal funding for medical research.
Mandates distribution of collected payments to the FDA and NIH, prioritizing urgent medical research needs.
Specifies that payments will not be distributed unless appropriations to the agencies are equal to or greater than the previous fiscal year.
Outlines priorities for the use of distributed funds, including advancing regulatory science, supporting innovative research, and aiding early career scientists.
Requires annual reports from the Secretary of Health and Human Services, FDA, and NIH on the assessment, collection, and impact of the supplemental payments.