21 USC 355 - Utilizing real world evidence

View all text of Part A [§ 351 - § 360n-2]

§ 355g. Utilizing real world evidence

(a) In generalThe 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

(1) In general

(2) Contents of frameworkThe 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;

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

(3) Consultation

(A) In general

(B) ProcessThe 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

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(2) not later than 5 years after December 13, 2016, issue draft guidance for industry as described in paragraph (1); and

(3) not later than 18 months after the close of the public comment period for the draft guidance described in paragraph (2), issue revised draft guidance or final guidance.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

(2) Standards of evidence and Secretary’s authorityThis 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; amended Pub. L. 115–52, title IX, § 901(c), (d), Aug. 18, 2017, 131 Stat. 1076.)