To amend the Federal Food, Drug, and Cosmetic Act to evaluate the potential use of evidence from clinical experience to help support the approval of new indications for approved drugs, and for other purposes.

Summary: This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a program to evaluate the potential use of evidence from clinical experience to support the approval of a new indication for an approved drug and to support post-approval study requirements. &quot;Evidence from clinical experience&quot; means data from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use. Before implementing the program, the FDA must establish a draft framework for the program that describes current sources of data from clinical experience, gaps in current data collection activities, standards and methodologies for collection and analysis of data from clinical experience, and priority areas, remaining challenges, and potential pilot opportunities that the program will address. The FDA must use the program to inform guidance to industry on the collection and use of evidence from clinical experience.

SECTION 1. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 505E of such Act (21 U.S.C. 355f) the 
following:

``SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.

    ``(a) In General.--The Secretary shall establish a program to 
evaluate the potential use of evidence from clinical experience--
            ``(1) to help support the approval of a new indication for 
        a drug approved under section 505(b); and
            ``(2) to help support or satisfy post-approval study 
        requirements.
    ``(b) Evidence From Clinical Experience Defined.--In this section, 
the term `evidence from clinical experience' means data regarding the 
usage, or potential benefits or risks, of a drug derived from sources 
other than randomized clinical trials, including from observational 
studies, registries, and therapeutic use.
    ``(c) Program Framework.--
            ``(1) In general.--Not later than 18 months after the date 
        of enactment of this section, 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 current sources of data developed through 
                clinical experience, including ongoing safety 
                surveillance, registry, claims, and patient-centered 
                outcomes research activities;
                    ``(B) the gaps in current data collection 
                activities;
                    ``(C) the current standards and methodologies for 
                collection and analysis of data generated through 
                clinical experience; 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, 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; or
                            ``(ii) a contract, grant, or other 
                        arrangement, as determined appropriate by the 
                        Secretary with such a partnership or an 
                        independent research organization.
    ``(d) Program Implementation.--The Secretary shall, not later than 
24 months after the date of enactment of this section and in accordance 
with the framework established under subsection (c), implement the 
program to evaluate the potential use of evidence from clinical 
experience.
    ``(e) Guidance for Industry.--The Secretary shall--
            ``(1) utilize the program established in subsection (d), 
        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 evidence from 
                clinical experience for the purposes described in 
                subsections (a)(1) or (a)(2); and
                    ``(B) the appropriate standards and methodologies 
                for collection and analysis of evidence from clinical 
                experience submitted for such purposes;
            ``(2) not later than 36 months after the date of enactment 
        of this section, issue draft guidance for industry as described 
        in paragraph (1); and
            ``(3) not later than 48 months after the date of enactment 
        of this section, after providing an opportunity for public 
        comment on the draft guidance, issue final guidance.
    ``(f) Rule of Construction.--
            ``(1) Subject to paragraph (2), nothing in this section 
        prohibits the Secretary from using evidence from clinical 
        experience for purposes not specified in this section, provided 
        the Secretary determines that sufficient basis exists for any 
        such non-specified use.
            ``(2) This section shall not be construed to alter--
                    ``(A) the standards of evidence under--
                            ``(i) subsection (c) or (d) of section 505, 
                        including the substantial evidence standard in 
                        such subsection (d); or
                            ``(ii) section 351(a) of the Public Health 
                        Service Act; or
                    ``(B) the Secretary's authority to require post-
                approval studies or clinical trials, or the standards 
                of evidence under which studies or trials are 
                evaluated.''.