[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4374 Introduced in House (IH)]
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115th CONGRESS
1st Session
H. R. 4374
To amend the Federal Food, Drug, and Cosmetic Act to authorize
additional emergency uses for medical products to reduce deaths and
severity of injuries caused by agents of war, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 13, 2017
Mr. Walden introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
Armed Services, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to authorize
additional emergency uses for medical products to reduce deaths and
severity of injuries caused by agents of war, 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. ADDITIONAL EMERGENCY USES FOR MEDICAL PRODUCTS TO REDUCE
DEATHS AND SEVERITY OF INJURIES CAUSED BY AGENTS OF WAR.
(a) FDA Authorization for Medical Products for Use in
Emergencies.--Section 564 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-3) is amended--
(1) in subsection (b)--
(A) in paragraph (1), by amending subparagraph (B)
to read as follows:
``(B) a determination by the Secretary of Defense
that there is a military emergency, or a significant
potential for a military emergency, involving a
heightened risk to United States military forces,
including personnel operating under the authority of
title 10 or title 50, United States Code, of attack
with--
``(i) a biological, chemical, radiological,
or nuclear agent or agents; or
``(ii) an agent or agents that may cause,
or are otherwise associated with, an imminently
life-threatening and specific risk to United
States military forces;''; and
(B) by adding at the end the following:
``(6) Military emergencies.--In the case of a determination
described in paragraph (1)(B), the Secretary shall determine,
within 45 calendar days of such determination, whether to make
a declaration under paragraph (1), and, if appropriate, shall
promptly make such a declaration.''; and
(2) in subsection (c)--
(A) in paragraph (3), by striking ``; and'' and
inserting ``;'';
(B) by redesignating paragraph (4) as paragraph
(5); and
(C) by inserting after paragraph (3) the following:
``(4) in the case of a determination described in
subsection (b)(1)(B)(ii), that the request for emergency use is
made by the Secretary of Defense; and''.
(b) Emergency Uses for Medical Products.--
(1) In general.--The Secretary of Defense may request that
the Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, take actions to expedite the
development of a medical product, review of investigational new
drug applications under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)), review of
investigational device exemptions under section 520(g) of such
Act (21 U.S.C. 360j(g)), and review of applications for
approval and clearance of medical products under sections 505,
510(k), and 515 of such Act (21 U.S.C. 355, 360(k), 360(e)) and
section 351 of the Public Health Service Act (42 U.S.C. 262),
including applications for licensing of vaccines or blood as
biological products under such section 351, or applications for
review of regenerative medicine advanced therapy products under
section 506(g) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 356(g)), if there is a military emergency, or
significant potential for a military emergency, involving a
specific and imminently life-threatening risk to United States
military forces of attack with an agent or agents, and the
medical product that is the subject of such application,
submission, or notification would be reasonably likely to
diagnose, prevent, treat, or mitigate such life-threatening
risk.
(2) Actions.--Upon a request by the Secretary of Defense
under paragraph (1), the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall take action to expedite the development and review of an
applicable application or notification with respect to a
medical product described in paragraph (1), which may include,
as appropriate--
(A) holding meetings with the sponsor and the
review team throughout the development of the medical
product;
(B) providing timely advice to, and interactive
communication with, the sponsor regarding the
development of the medical product to ensure that the
development program to gather the nonclinical and
clinical data necessary for approval or clearance is as
efficient as practicable;
(C) involving senior managers and experienced
review staff, as appropriate, in a collaborative,
cross-disciplinary review;
(D) assigning a cross-disciplinary project lead for
the review team to facilitate an efficient review of
the development program and to serve as a scientific
liaison between the review team and the sponsor;
(E) taking steps to ensure that the design of the
clinical trials is as efficient as practicable, when
scientifically appropriate, such as by minimizing the
number of patients exposed to a potentially less
efficacious treatment;
(F) applying any applicable Food and Drug
Administration program intended to expedite the
development and review of a medical product; and
(G) in appropriate circumstances, permitting
expanded access to the medical product during the
investigational phase, in accordance with applicable
requirements of the Food and Drug Administration.
(3) Enhanced collaboration and communication.--In order to
facilitate enhanced collaboration and communication with
respect to the most current priorities of the Department of
Defense--
(A) the Food and Drug Administration shall meet
with the Department of Defense and any other
appropriate development partners, such as the
Biomedical Advanced Research and Development Authority,
on a semi-annual basis for the purposes of conducting a
full review of the relevant products in the Department
of Defense portfolio; and
(B) the Director of the Center for Biologics
Evaluation and Research shall meet quarterly with the
Department of Defense to discuss the development status
of regenerative medicine advanced therapy, blood, and
vaccine medical products and projects that are the
highest priorities to the Department of Defense (which
may include freeze dried plasma products and platelet
alternatives),
unless the Secretary of Defense determines that any such
meetings are not necessary.
(4) Medical product.--In this subsection, the term
``medical product'' means a drug (as defined in section 201 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), a
device (as defined in such section 201), or a biological
product (as defined in section 351 of the Public Health Service
Act (42 U.S.C. 262)).
(c) Repeal.--Effective as of the enactment of the National Defense
Authorization Act for Fiscal Year 2018, subsection (d) of section 1107a
of title 10, United States Code, as added by section 716 of the
National Defense Authorization Act for Fiscal Year 2018, is repealed.
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