(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.
(c) Program framework(1) In generalNot 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 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;
(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 generalIn 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) 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.
(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(2) not later than 5 years after December 13, 2016, issue draft guidance for industry as described in paragraph (1); and
(3) not later than 18 months after the close of the public comment period for the draft guidance described in paragraph (2), issue revised draft guidance or final guidance.
(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.)