Sec. 4. National Academy of Medicine study on determining a reasonable drug price
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/bill/116/s/2387/is/section-4·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than 60 days after the date of enactment of this Act, the Secretary shall seek to enter into a contract with the National Academy of Medicine (referred to in this section as the Academy ) under which the Academy agrees to study— how best to determine the reasonableness of a drug’s manufacturer list price and retail price and develop at least 1 framework for determining the reasonableness of a drug’s manufacturer list price and retail price taking into consideration— affordability of the drug to payers, purchasers, and patients across wide market segments in a manner that ensures equitable access; investment by the National Institutes of Health or any other Federal Government entity in the development of the drug; inclusion of research funded by the National Institutes of Health or other Federal Government entity in the development of the drug; manufacturer research and development costs as shown on the manufacturer’s Federal tax filing under sections 41 and 174 of the Internal Revenue Code of 1986; investment and the rate of return needs for the drug manufacturer; market for the drug; the cost of production and distribution of the drug; the price of the drug in other similar, industrialized countries; estimated global and domestic sales of the drug; gross and net expenditures by public payers for coverage of the drug under Federal health programs, to the extent available; and any additional information the Academy determines appropriate; an appropriate timeline for the submission of information to the Drug Affordability and Access Committee required under section 6(a)(2) to determine the reasonableness of a drug’s manufacturer list price and retail price; and an appropriate timeline for the Drug Affordability and Access Committee to determine the reasonableness of a drug’s manufacturer list price and retail price to be in effect the second year after coming to market.
Any contract between the Secretary and the Academy under this section shall include a requirement that the Academy submit a report on the results of the study described in subsection
(a)to the Secretary, the Drug Affordability and Access Committee, and Congress.