Sec. 202. Naloxone
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Not later than the date that is one year after the date of enactment of this Act, and annually thereafter, to better understand how research and development costs, manufacturing and marketing costs, acquisitions, Federal investments, revenues and sales, and other factors influence drug prices, each manufacturer of naloxone or any other drug approved by the Food and Drug Administration for opioid overdose reversal shall report to the Secretary— with respect to naloxone (or such other drug)— total expenditures of the manufacturer on— materials and manufacturing for such drug; acquiring patents and licensing; and costs to purchase or acquire the drug from another company, if applicable; the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from Federal funds; the total expenditures of the manufacturer on research and development for such drug; the total revenue and net profit generated from the applicable drug for each calendar year since drug approval; the total expenditures of the manufacturer that are associated with marketing and advertising for such drug; the wholesale acquisition cost for such drug; the average out-of-pocket cost of such drug to the consumer; patient utilization rates for such drug; and additional information specific to the manufacturer as the Secretary may require, to include at a minimum— the total revenue and net profit of the manufacturer for the reporting period; metrics used to determine executive compensation; and any additional information related to drug pricing decisions of the manufacturer, 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.
The reporting period for the reports under paragraph
(1)shall be as follows: For the initial report under paragraph (1), the 10-year period preceding the report. For subsequent reports, the 12-month period preceding the respective reports. Subject to subparagraph (B), not later than 30 days after receiving the information under paragraph (1), the Secretary shall post on the internet website of the Centers for Medicare & Medicaid Services the information reported under paragraph
(1)in written format and using language that is easily understandable by beneficiaries under titles XVIII and XIX of the Social Security Act ( 42 U.S.C. 1395 et seq.; 1396 et seq.). The Secretary shall exclude proprietary information, such as trade secrets and intellectual property, submitted by the manufacturer under paragraph
(1)from the posting described in subparagraph (A). The Commissioner of Food and Drugs shall— not later one year after the date of enactment of this Act, determine whether naloxone should remain subject to the requirements of section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(b)(1) ) or be reclassified as an over-the-counter drug; and take such actions as may be appropriate, consistent with such determination.
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