Sec. 805. Facilitating the use of real world evidence

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Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue, or revise existing, guidance on considerations for the use of real world data and real world evidence to support regulatory decisionmaking, as follows: With respect to drugs, such guidance shall address— the use of such data and evidence to support the approval of a drug application under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) or a biological product application under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), or to support an investigational use exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act or section 351(a)(3) of the Public Health Service Act; and the use of such data and evidence obtained as a result of the use of drugs authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) in such applications, submissions, or requests; and standards and methodologies which may be used for collection and analysis of real world evidence included in such applications, submissions, or requests, as appropriate.

With respect to devices, such guidance shall address— the use of such data and evidence to support the approval, clearance, or classification of a device pursuant to an application or submission submitted under section 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) , 360c(f)(2), 360e), or to support an investigational use exemption under section 520(g) of such Act ( 21 U.S.C. 360j(g) ); the use of such data and evidence obtained as a result of the use of devices authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ), in such applications, submissions, or requests; and standards and methodologies which may be used for collection and analysis of real world evidence included in such applications, submissions, or requests, as appropriate.

Not later than 2 years after the termination of the public health emergency determination by the Secretary of Health and Human Services under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) on February 4, 2020, with respect to the Coronavirus Disease 2019 (COVID–19), the Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on— the number of applications, submissions, or requests submitted for clearance or approval under section 505, 510(k), 513(f)(2), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 , 360(k), 360c(f)(2), 360e) or section 351 of the Public Health Service Act, for which an authorization under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) was previously granted; of the number of applications so submitted, the number of such applications— for which real world evidence was submitted and used to support a regulatory decision; and for which real world evidence was submitted and determined to be insufficient to support a regulatory decision; and a summary explanation of why, in the case of applications described in paragraph (2)(B), real world evidence could not be used to support regulatory decisions.

Nothing in this section shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 1905 of title 18, United States Code, or subject to withholding under subsection (b)(4) of section 552 of title 5, United States Code (commonly referred to as the Freedom of Information Act ).

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21 USC 355
42 USC 262
21 USC 360bbb–3
21 USC 360(k)
21 USC 360j(g)

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Sec. 805

Facilitating the use of real world evidence

Cite21 USC 355

Cite42 USC 262

Cite21 USC 360bbb–3

Cite21 USC 360(k)

Cite21 USC 360j(g)

Cites 5Cited by 0 across 0 sources