Sec. 304. Increasing use of real world evidence
519 words·~2 min read·
/bill/117/hr/6000/ih/section-304·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than 6 months after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the Secretary ) shall issue guidance on the use of real world evidence in evaluating the safety and effectiveness of breakthrough devices (developed pursuant to section 515B of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e–3 )) and breakthrough drugs subsequent to the approval or licensing of such drugs pursuant to subsection (a), (b), or
(c)of section 506 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356 ) as a breakthrough therapy, a fast track product, or a product considered for accelerated approval. The guidance under paragraph
(1)shall take into consideration each of the following: Special and underrepresented populations. Acceptable endpoints and outcomes measures. Data quality standards. Data transparency requirements. Study design considerations. Consistent with the framework established under 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g ), the Secretary of Health and Human Services shall, by not later than 1 year after the date of the enactment of this Act— identify consistent, clear approaches for the Department of Health and Human Services to use real world evidence (as defined in such section 505F)— in conducting and supporting research; and in regulating, purchasing, and supporting the purchase of health care products and services; include in such approaches recommendations for any additional statutory authorities needed; publish such approaches in the Federal Register; and submit a report to the Congress on such approaches. Upon publication under paragraph
(1)of the approaches identified pursuant to such paragraph, consistent with the authorities vested in the Department of Health and Human Services by other provisions of law, the Secretary take such actions as may be appropriate to implement the approaches identified pursuant to paragraph (1). The Secretary shall establish a permanent task force, to be known as the Real World Evidence Task Force (in this subsection referred to as the Task Force ) to coordinate the programs and activities of the Department of Health and Human Services with regard to the collection and use of real world evidence. The members of the Task Force shall include the following: The Secretary (or the Secretary’s designee), who shall serve as the Chair of the Task Force. The Administrator of the Centers for Medicare & Medicaid Services (or the Administrator’s designee). The Commissioner of Food and Drugs (or the Commissioner’s designee). The Director of the National Institutes of Health (or the Director’s designee). Such additional Federal officials (or their designees) as the Secretary determines appropriate. Private sector representatives, including patient group representatives, to be appointed by the Secretary. In carrying paragraph (1), the Task Force shall— develop and periodically update recommendations on ways to encourage patients to— engage in the generation of real world evidence; and participate in postapproval clinical trials for the collection of real world evidence; and not later than 2 years after the date of the enactment of this Act, and every 2 years thereafter, submit a report to the Congress on such recommendations.
Connectionstraces to 2
1 reference not yet in our index
- 21 USC 360e–3
Citation graph
cites case law
Cites 3Cited by 0 across 0 sources