Sec. 2062. Utilizing evidence from clinical experience
1,019 words·~5 min read·
/bill/114/hr/6/rh/section-2062A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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: The Secretary shall establish a program to evaluate the potential use of evidence from clinical experience— to help to support the approval of a new indication for a drug approved under section 505(b); and to help to support or satisfy postapproval study requirements. In this section, the term evidence from clinical experience means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.
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. The framework shall include information describing— the current sources of data developed through clinical experience, including ongoing safety surveillance, registry, claims, and patient-centered outcomes research activities; the gaps in current data collection activities; the current standards and methodologies for collection and analysis of data generated through clinical experience; and the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.
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. 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; or a contract, grant, or other arrangement, as determined appropriate by the Secretary with such a partnership or an independent research organization. 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. 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 evidence from clinical experience for the purposes described in subsection (a)(1) or (a)(2); and the appropriate standards and methodologies for collection and analysis of evidence from clinical experience submitted for such purposes; not later than 36 months after the date of enactment of this section, issue draft guidance for industry as described in paragraph (1); and 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. 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 nonspecified use. This section shall not be construed to alter— the standards of evidence under— subsection
(c)or
(d)of section 505, including the substantial evidence standard in such subsection (d); or section 351(a) of the Public Health Service Act; or the Secretary’s authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated. The Secretary shall, in parallel to implementing the program established under section 505F and in order to build capacity for utilizing the evidence from clinical experience described in that section, identify and execute pilot demonstrations to extend existing use of the Sentinel System surveillance infrastructure authorized under section 505(k). The Secretary— shall design and implement pilot demonstrations to utilize data captured through the Sentinel System surveillance infrastructure authorized under section 505(k) for purposes of, as appropriate— generating evidence from clinical experience to improve characterization or assessment of risks or benefits of a drug approved under section 505(c); protecting the public health; or advancing patient-centered care; and may make strategic linkages with sources of complementary public health data and infrastructure the Secretary determines appropriate and necessary. In developing the pilot demonstrations 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 through a public process; and develop a framework to promote appropriate transparency and dialogue about research conducted under these pilot demonstrations, including by— providing adequate notice to a sponsor of a drug approved under section 505 or section 351 of the Public Health Service Act of the Secretary’s intent to conduct analyses of such sponsor’s drug or drugs under these pilot demonstrations; providing adequate notice of the findings related to analyses described in clause
(i)and an opportunity for the sponsor of such drug or drugs to comment on such findings; and ensuring the protection from public disclosure of any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. The Secretary may— deem such pilot demonstrations public health activities, permitting the use and disclosure of protected health information as described in section 164.512(b)(1)(iii) of title 45, Code of Federal Regulations (or any successor regulation) and exempted as a public health activity as described in section 46.101(b)(5) of title 46, Code of Federal Regulations (or any successor regulation); and deem safety surveillance performed at the request of the Food and Drug Administration or under such jurisdiction by a sponsor with responsibility for a drug approved under this section or section 351 of the Public Health Services Act using the Sentinel System surveillance infrastructure authorized under section 505(k), including use of analytic tools and querying capabilities developed to implement the active postmarket surveillance system described in this section, public health activities as described in section 164.512(b)(1)(iii) of title 45, Code of Federal Regulations (or any successor regulation) and exempted as a public health activity as described in section 46.101(b)(5) of title 46, Code of Federal Regulations (or any successor regulation). There are authorized to be appropriated to carry out this section $3,000,000 for each of fiscal years 2016 through 2020. .
Connectionstraces to 1
Traces to 1 document
Citation graph
cites case law
Sec. 2062
Utilizing evidence from clinical experience
Cites 1Cited by 0 across 0 sources