21 U.S.C. § 355g (FOOD AND DRUGS)
§ 355g. Utilizing real world evidence
(a) In general
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) Real world evidence defined
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 randomized clinical trials.
(c) Program framework
(1) In general
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) Contents of framework
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) Consultation
(A) In general
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) Process
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) Program implementation
The Secretary shall, not later than 2 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) Guidance for industry
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) Rule of construction
(1) In general
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) Standards of evidence and Secretary’s authority
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.
(June 25, 1938, ch. 675, § 505F, as added Pub. L. 114–255, div. A, title III, § 3022, Dec. 13, 2016, 130 Stat. 1096.)