21 U.S.C. § 355g — Utilizing real world evidence

(a) In general The Secretary must establish a program to evaluate whether "real world evidence" can be used to (1) help support approving a new indication for a drug already approved under section 355(c), and (2) help support or satisfy requirements for studies done after approval. (b) Real world evidence defined In this section, "real world evidence" means data about the usage, or the potential benefits or risks, of a drug, that comes from sources other than traditional clinical trials. (c) Program framework (1) In general: Within 2 years after December 13, 2016, the Secretary must establish a draft framework for how the program will be carried out. (2) Contents of framework: The framework must describe: (A) the sources of real world evidence, such as ongoing safety surveillance, observational studies, registries, claims data, and patient-centered outcomes research; (B) the gaps in current data collection activities; (C) the standards and methods for collecting and analyzing real world evidence; and (D) the priority areas, remaining challenges, and potential pilot projects the program will address. (3) Consultation: (A) In general: In developing the framework, the Secretary must consult regulated industry, academia, medical professional organizations, patient advocacy organizations, consumer organizations, disease research foundations, and other interested parties. (B) Process: This consultation may happen through a public-private partnership the Secretary may join, a contract, grant, or other arrangement with such a partnership or an independent research organization, or public workshops with these groups. (d) Program implementation Within 3 years after December 13, 2016, and following the framework built under subsection (c), the Secretary must actually implement the program to evaluate real world evidence. (e) Guidance for industry The Secretary must: (1) use the program, its activities, and any resulting pilots or written reports to inform guidance for industry on (A) when sponsors of drugs and the Secretary may rely on real world evidence for the two purposes in subsection (a), and (B) the appropriate standards and methods for collecting and analyzing that evidence; (2) issue that draft guidance no later than 5 years after December 13, 2016; and (3) issue revised draft guidance or final guidance within 18 months after the public comment period on the draft guidance closes. (f) Rule of construction (1) In general: Subject to paragraph (2), nothing in this section stops the Secretary from using real world evidence for purposes not listed in this section, as long as the Secretary determines there is a sufficient basis for that other use. (2) Standards of evidence and Secretary's authority: This section does not change (A) the evidence standards under section 355(c) or (d) — including the "substantial evidence" standard in subsection (d) — or under 42 U.S.C. § 262(a); or (B) the Secretary's authority to require post-approval studies or clinical trials, or the standards used to evaluate them.