[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7008 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 7008
To improve patient access to emerging medication therapies by
clarifying the scope of permitted health care economic and scientific
information communications between biopharmaceutical manufacturers and
population health decision makers, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 9, 2022
Mr. Guthrie introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To improve patient access to emerging medication therapies by
clarifying the scope of permitted health care economic and scientific
information communications between biopharmaceutical manufacturers and
population health decision makers, 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. SHORT TITLE.
This Act may be cited as the ``Pre-approval Information Exchange
Act of 2022''.
SEC. 2. FACILITATING EXCHANGE OF INFORMATION PRIOR TO APPROVAL.
Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(a)) is amended--
(1) by redesignating subparagraph (2) as subparagraph (3);
(2) by inserting after subparagraph (1) the following:
``(2)(A) Health care economic information, scientific information,
or product support information provided to a covered payor responsible
for the selection of drugs or devices for coverage, reimbursement, or
other population-based health care management, shall not be considered
false or misleading or any other form of misbranding under this section
or a violation of section 505, 510(k), 513, or 515 of this Act or
section 351 of the Public Health Service Act, or otherwise prohibited
pre-approval promotion of a drug or device, if it--
``(i)(I) in the case of health care economic information,
is based on competent and reliable scientific evidence; or
``(II) in the case of scientific information other than
health care economic information, is truthful and
nonmisleading; and
``(ii) relates to an investigational drug or device or
investigational use of a drug or device that is approved,
cleared, or licensed under section 505, 510(k), 513, or 515 of
this Act or section 351 of the Public Health Service Act (as
applicable).
``(B) In order to provide information pursuant to this subparagraph
relating to an investigational drug or device, or an investigational
use of an drug or device that has been approved, granted marketing
authorization, cleared, or licensed--
``(i) the information must include--
``(I) a clear statement that the investigational
drug or device or investigational use of a drug or
device has not been approved, cleared, or licensed
under section 505, 510(k), 513, or 515 of this Act or
section 351 of the Public Health Service Act (as
applicable) and that the safety and effectiveness of
the drug or device or use has not yet been established;
``(II) information related to the stage of
development of the drug or device involved, such as--
``(aa) the status of any study or studies
in which the investigational drug or device or
investigational use is being investigated;
``(bb) how the study or studies relate to
the overall plan for the development of the
drug or device;
``(cc) whether a marketing application or
notification for the investigational drug or
device or investigational use has been
submitted to the Secretary and when such a
submission is planned;
``(III) in the case of communications that include
factual presentations of results from studies, a
description of--
``(aa) material aspects of study design,
methodology, and results; and
``(bb) material limitations related to the
study design, methodology, and results; and
``(IV) where applicable, a conspicuous and
prominent statement describing any material differences
between the information provided and the labeling
approved, granted marketing authorization, cleared, or
licensed pursuant to section 505, 510(k), 513, or 515
of this Act or section 351 of the Public Health Service
Act.
``(C) For purposes of this subparagraph--
``(i) the term `covered payor' means a payor, formulary
committee, drug information center, technology assessment
committee, pharmacy benefit manager, and other
multidisciplinary entity that, on behalf of health care
organizations, reviews scientific or technology assessments, or
other similar entity with knowledge and expertise to evaluate
health care economic analysis or scientific information on a
population basis;
``(ii) the term `product support information' includes--
``(I) information describing the drug or device
(such as drug class, device description, and features);
``(II) information about the indication or
indications sought;
``(III) the anticipated timeline for a possible
approval, clearance, or licensure pursuant to section
505, 510(k), 513, or 515 of this Act or section 351 of
the Public Health Service Act;
``(IV) drug or device pricing information;
``(V) patient utilization projections; and
``(VI) product-related programs or services.
``(iii) the term `scientific information' includes clinical
and pre-clinical data and results relating to a drug or device
or use that has not been approved, granted marketing
authorization, cleared, or licensed and is being investigated
or developed.'';
(3) in subparagraph (3), as redesignated--
(A) by striking ``(A)'';
(B) by striking clause (B); and
(C) by striking ``drug'' each place it appears and
inserting ``drug or device''; and
(4) by adding at the end the following:
``(4) Nothing in this section shall be construed to limit the
ability of manufacturers or sponsors of drugs or devices to engage in
communications or activities not specified in subparagraph (2) or (3)
that are otherwise permissible.''.
SEC. 3. GAO STUDY AND REPORT.
Beginning on the date that is 5 years and 6 months after the date
of enactment of this Act, the Comptroller General of the United States
(in this subsection referred to as the ``Comptroller General'') shall
conduct a study on the provision and use of information pursuant to
section 502(a)(2) of the Federal Food, Drug, and Cosmetic Act, as added
by section 2 of this Act, between manufacturers of, and covered
entities (as defined in such section 502(a)(2)) for, drugs and devices
(as defined in section 201 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321)). Such study shall include an analysis of the
following:
(1) The type of information communicated between such
manufacturers and payors.
(2) The manner of communication between such manufacturers
and payors.
(3)(A) Whether such manufacturers file a submission for
approval, marketing authorization, clearance, or licensing of a
new drug or device or the new use of a drug or device that is
the subject of communication between such manufacturers and
payors before the new use is approved, granted marketing
authorization, cleared, or licensed.
(B) How frequently the Food and Drug Administration
approves, grants marketing authorization, clears, or licenses
the new drug or device or new use.
(C) The timeframe between the initial communications under
section 502(a) of the Federal Food, Drug, and Cosmetic Act, as
amended by this Act, regarding an investigational drug or
device or investigational use, and the initial marketing of
such drug or device or investigational use.
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