[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2416 Introduced in House (IH)]
114th CONGRESS
1st Session
H. R. 2416
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.
_______________________________________________________________________
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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.''.
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