Pre-Approval Information Exchange Act of 2022
This bill specifies that product information that is exchanged between drug manufacturers and certain health care entities (e.g., formulary committees) about drug products before regulatory approval is not considered to be misbranding if it relates to the product's investigational use and meets other specified criteria. The Government Accountability Office must study the use and effects of such information.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9297 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 9297
To amend the Federal Food, Drug, and Cosmetic Act to facilitate the
exchange of certain product information, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 15, 2022
Mr. Guthrie (for himself, Ms. Eshoo, Mr. Griffith, Mr. Peters, Mr.
Burgess, and Ms. Matsui) 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 facilitate the
exchange of certain product information, 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 PRODUCT INFORMATION PRIOR TO APPROVAL.
(a) In General.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended--
(1) in paragraph (a)--
(A) by striking ``drugs for coverage'' and
inserting ``drugs or devices for coverage''; and
(B) by striking ``drug'' each place it appears and
inserting ``drug or device'', respectively;
(2) in paragraphs (a)(1) and (a)(2)(B), by striking ``under
section 505 or under section 351 of the Public Health Service
Act'' and inserting ``under section 505, 510(k), 513(f)(2), or
515 of this Act or section 351 of the Public Health Service
Act'';
(3) in paragraph (a)(1)--
(A) by striking ``under section 505 or under
section 351(a) of the Public Health Service Act'' and
inserting ``under section 505, 510(k), 513(f)(2), or
515 of this Act or section 351 of the Public Health
Service Act''; and
(B) by striking ``in section 505(a) or in
subsections (a) and (k) of section 351 of the Public
Health Service Act'' and inserting ``in section 505,
510(k), 513(f)(2), or 515 of this Act or section 351 of
the Public Health Service Act''; and
(4) by adding at the end the following:
``(gg)(1) Unless its labeling bears adequate directions for use in
accordance with paragraph (f), except that (in addition to drugs or
devices that conform with exemptions pursuant to such paragraph) no
drug or device shall be deemed to be misbranded under such paragraph
through the provision of product information to a payor, formulary
committee, or other similar entity with knowledge and expertise in the
area of health care economic analysis carrying out its responsibilities
for the selection of drugs or devices for coverage or reimbursement if
the product information relates to an investigational drug or device or
investigational use of a drug or device that is approved, cleared,
granted marketing authorization, or licensed under section 505, 510(k),
513(f)(2), or 515 of this Act or section 351 of the Public Health
Service Act (as applicable), provided--
``(A) the product information includes--
``(i) a clear statement that the investigational
drug or device or investigational use of a drug or
device has not been approved, cleared, granted
marketing authorization, or licensed under section 505,
510(k), 513(f)(2), 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 been established;
``(ii) information related to the stage of
development of the drug or device involved, such as--
``(I) the status of any study or studies in
which the investigational drug or device or
investigational use is being investigated;
``(II) how the study or studies relate to
the overall plan for the development of the
drug or device; and
``(III) whether an application, premarket
notification, or request for classification 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 information that includes
factual presentations of results from studies, which
shall not be selectively presented, a description of--
``(I) all material aspects of study design,
methodology, and results; and
``(II) all material limitations related to
the study design, methodology, and results;
``(iv) where applicable, a prominent statement
disclosing the indication or indications for which the
Secretary has approved, granted marketing
authorization, cleared, or licensed the product
pursuant to section 505, 510(k), 513(f)(2), or 515 of
this Act or section 351 of the Public Health Service
Act, and a copy of the most current required labeling;
and
``(v) updated information, if previously
communicated information becomes materially outdated as
a result of significant changes or as a result of new
information regarding the product or its review status;
and
``(B) the product information does not include--
``(i) information that represents that an
unapproved product--
``(I) has been approved, cleared, granted
marketing authorization, or licensed under
section 505, 510(k), 513(f)(2), or 515 of this
Act or section 351 of the Public Health Service
Act (as applicable); or
``(II) has otherwise been determined to be
safe or effective for the purpose or purposes
for which the drug or device is being studied;
or
``(ii) information that represents that an
unapproved use of a drug or device that has been so
approved, granted marketing authorization, cleared, or
licensed--
``(I) is so approved, granted marketing
authorization, cleared, or licensed; or
``(II) that the product is safe or
effective for the use or uses for which the
drug or device is being studied.
``(2) For purposes of this paragraph, the term `product
information' includes--
``(A) information describing the drug or device (such as
drug class, device description, and features);
``(B) information about the indication or indications being
investigated;
``(C) the anticipated timeline for a possible approval,
clearance, marketing authorization, or licensure pursuant to
section 505, 510(k), 513, or 515 of this Act or section 351 of
the Public Health Service Act;
``(D) drug or device pricing information;
``(E) patient utilization projections;
``(F) product-related programs or services; and
``(G) factual presentations of results from studies that do
not characterize or make conclusions regarding safety or
efficacy.''.
(b) 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 shall conduct a study on the provision and
use of information pursuant to section 502(gg) of the Federal Food,
Drug, and Cosmetic Act, as added by this subsection (a), between
manufacturers of drugs and devices (as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) and entities
described in such section 502(gg). Such study shall include an analysis
of the following:
(1) The types of information communicated between such
manufacturers and payors.
(2) The manner of communication between such manufacturers
and payors.
(3)(A) Whether such manufacturers file an application 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 under section 502(gg) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a).
(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
permitted under section 502(gg) of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a), regarding an
investigational drug or device or investigational use, and the
initial marketing of such drug or device.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Llama 3.2 · runs locally in your browser
Ask anything about this bill. The AI reads the full text to answer.
Enter to send · Shift+Enter for new line