§355g — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary must set up a program to test how “real world evidence” can be used to support a new approved use for a drug and to meet post‑approval study needs. Real world evidence means information about how a drug is used or its benefits or risks that comes from sources other than traditional clinical trials. The Secretary must write a draft plan within 2 years after December 13, 2016, saying where such data can come from (for example, safety monitoring, observational studies, registries, insurance claims, and patient‑outcome research), what data are missing, how to collect and analyze the data, and what priority problems or pilot projects to try. The Secretary must consult industry, academia, doctors, patient groups, consumer groups, research foundations, and others, and may do this through partnerships, contracts, or public workshops. The program must be put into action within 3 years after December 13, 2016. The Secretary must use the program and any pilot work to make guidance for industry about when and how to rely on real world evidence and what standards to use. A draft guidance must be published within 5 years after December 13, 2016, and a revised draft or final guidance must follow within 18 months after the public comment period ends. The Secretary may use real world evidence for other purposes if there is a sufficient basis, but this law does not change existing evidence standards for drugs or biologics or the Secretary’s authority to require postapproval studies or clinical trials.

Title 21, §355g

Food and Drugs — Source: USLM XML via OLRC

(a)The Secretary shall establish a program to evaluate the potential use of real world evidence—

(1)to help to support the approval of a new indication for a drug approved under section 355(c) of this title; and

(2)to help to support or satisfy postapproval study requirements.

(b)In this section, the term “real world evidence” means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.

(c)(1)Not later than 2 years after December 13, 2016, the Secretary shall establish a draft framework for implementation of the program under this section.

(2)The framework shall include information describing—

(A)the sources of real world evidence, including ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities;

(B)the gaps in data collection activities;

(C)the standards and methodologies for collection and analysis of real world evidence; and

(D)the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.

(3)(A)In developing the program framework under this subsection, the Secretary shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, consumer organizations, disease research foundations, and other interested parties.

(B)The consultation under subparagraph (A) may be carried out through approaches such as—

(i)a public-private partnership with the entities described in such subparagraph in which the Secretary may participate;

(ii)a contract, grant, or other arrangement, as the Secretary determines appropriate, with such a partnership or an independent research organization; or

(iii)public workshops with the entities described in such subparagraph.

(d)The Secretary shall, not later than 3 years after December 13, 2016, and in accordance with the framework established under subsection (c), implement the program to evaluate the potential use of real world evidence.

(e)The Secretary shall—

(1)utilize the program established under subsection (a), its activities, and any subsequent pilots or written reports, to inform a guidance for industry on—

(A)the circumstances under which sponsors of drugs and the Secretary may rely on real world evidence for the purposes described in paragraphs (1) and (2) of subsection (a); and

(B)the appropriate standards and methodologies for collection and analysis of real world evidence submitted for such purposes;

(2)not later than 5 years after December 13, 2016, issue draft guidance for industry as described in paragraph (1); and

(3)not later than 18 months after the close of the public comment period for the draft guidance described in paragraph (2), issue revised draft guidance or final guidance.

(f)(1)Subject to paragraph (2), nothing in this section prohibits the Secretary from using real world evidence for purposes not specified in this section, provided the Secretary determines that sufficient basis exists for any such nonspecified use.

(2)This section shall not be construed to alter—

(A)the standards of evidence under—

(i)subsection (c) or (d) of section 355 of this title, including the substantial evidence standard in such subsection (d); or

(ii)section 262(a) of title 42; or

(B)the Secretary’s authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.

Editorial Notes

Amendments

2017—Subsec. (b). Pub. L. 115–52, § 901(c), substituted “traditional” for “randomized”. Subsec. (d). Pub. L. 115–52, § 901(d), substituted “3 years” for “2 years”.

§355g Utilizing real world evidence

Summary

Title 21, §355g

Notes & Related Subsidiaries

Editorial Notes

Amendments

Citations & Metadata