I 114th CONGRESS 1st Session H. R. 2416 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Burgess introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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.

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: 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. .