Utilizing real world evidence
In general
The Secretary shall establish a program to evaluate the potential use of real world evidence—
to help to support the approval of a new indication for a drug approved under section 355(c) of this title; and
to help to support or satisfy postapproval study requirements.
Real world evidence defined
Program framework
In general
Contents of framework
The framework shall include information describing—
the sources of real world evidence, including ongoing safety surveillance, observational studies, registries, claims, and patient-centered outcomes research activities;
the gaps in data collection activities;
the standards and methodologies for collection and analysis of real world evidence; and
the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.
Consultation
In general
Process
The consultation under subparagraph (A) may be carried out through approaches such as—
a public-private partnership with the entities described in such subparagraph in which the Secretary may participate;
a contract, grant, or other arrangement, as the Secretary determines appropriate, with such a partnership or an independent research organization; or
public workshops with the entities described in such subparagraph.
Program implementation
Guidance for industry
The Secretary shall—
utilize the program established under subsection (a), its activities, and any subsequent pilots or written reports, to inform a guidance for industry on—
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
the appropriate standards and methodologies for collection and analysis of real world evidence submitted for such purposes;
not later than 5 years after
not later than 18 months after the close of the public comment period for the draft guidance described in paragraph (2), issue revised draft guidance or final guidance.
Rule of construction
In general
Standards of evidence and Secretary’s authority
This section shall not be construed to alter—
the standards of evidence under—
subsection (c) or (d) of section 355 of this title, including the substantial evidence standard in such subsection (d); or
the Secretary’s authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.