Sec. 601. Drug manufacturer reporting
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/bill/114/hr/3513/ih/section-601A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
The manufacturer of a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) shall submit to the Secretary of Health and Human Services and to Congress an annual report, which shall be made publicly available, outlining with respect to each such drug, during the previous calendar year— the total expenditures of the manufacturer on— drug research and development; clinical trials; materials and manufacturing; acquisition costs, including costs for the purchase of patents and licensing; and marketing and advertising for the promotion of the drug to consumers and prescribers; the total profit to the manufacturer attributable to such drug; the total amount of financial assistance the manufacturer has provided through patient prescription assistance programs with respect to such drug, if any; any Federal benefits received by the manufacturer, including tax credits, grants from the National Institutes of Health, and other Federal benefits with respect to such drug; and any additional information the manufacturer chooses to provide related to drug pricing decisions, such as total expenditures on drug research and development or clinical trials on drugs that failed to receive approval by the Food and Drug Administration.
In the case of a manufacturer of a drug that sells such drug to the Federal Government, including through the health programs of the Department of Veterans Affairs, the Department of Defense, and the Indian Health Service and through the Medicare program under title XVIII of the Social Security Act ( 42 U.S.C. 1395 et seq. ), or that has entered into an agreement under section 340B of the Public Health Service Act ( 42 U.S.C. 256b ), the manufacturer shall include in the report submitted under subsection
(a)information about the price of the drug, and profits from and volume of sales of the drug, in each foreign country in which the drug is sold, as applicable.
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