[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1122 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 1122
To improve the program to provide for priority review of human drug
applications to encourage treatment for agents that present national
security threats.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 30, 2023
Ms. Ernst introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To improve the program to provide for priority review of human drug
applications to encourage treatment for agents that present national
security threats.
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 ``Prioritizing Medical Countermeasures
for National Security Act of 2023''.
SEC. 2. EXTENSION AND EXPANSION OF MEDICAL COUNTERMEASURE PRIORITY
REVIEW VOUCHER PROGRAM.
(a) Definition of Medical Countermeasure Application.--Subsection
(a)(4) of section 565A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4a) is amended--
(1) in the paragraph heading, by striking ``material threat
medical'' and inserting ``medical'';
(2) in the matter preceding subparagraph (A), by striking
``material threat''; and
(3) by amending subparagraph (A) to read as follows:
``(A) is a human drug application for a drug that
is--
``(i) labeled for an indication to prevent
or treat a disease or condition specifically
caused by a chemical, biological, radiological,
or nuclear agent; and
``(ii) part of a class or category of drug
on the list described in subsection (b) at the
time of approval of the application.''.
(b) List of Medical Countermeasures for National Security
Threats.--Section 565A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4a) is amended--
(1) by redesignating subsections (b) through (g) as
subsections (c) through (g) and (i), respectively; and
(2) by inserting after subsection (a), the following:
``(b) List of Medical Countermeasures for National Security
Threats.--
``(1) In general.--The Secretary, acting through the
Assistant Secretary of Preparedness and Response, in
consultation with the Public Health Emergency Medical
Enterprise established under section 2801 of the Public Health
Service Act, including the Secretary of Defense, shall
establish and maintain a list of potentially eligible classes
and categories of drugs that are identified as necessary to
prevent or treat the diseases and conditions specifically
caused by a chemical, biological, radiological, or nuclear
agent that--
``(A) has the potential to lead to a public health
emergency with significant potential to affect national
security; or
``(B) may present a specific threat to the Armed
Forces.
``(2) Factors.--In establishing and revising the list under
paragraph (1), the Secretary may consider--
``(A) whether an eligible class or category of
drugs that is identified is--
``(i) needed to protect the public health,
using the same standard that applies with
respect to determinations of material threats
under section 319F-2(c)(2)(B)(ii) of the Public
Health Service Act; and
``(ii) determined to be a priority
(consistent with sections 302(2) and 304(a) of
the Homeland Security Act of 2002);
``(B) for any class or category of drugs under
consideration to address specific threats to the Armed
Forces, information provided by the Secretary of
Defense to help evaluate whether a priority review
voucher is necessary and beneficial to incentivize
product development for the Department of Defense use
and fielding;
``(C) whether the class or category of drug
requires incentivization in the form a priority review
voucher based upon economic factors, such as whether
there is a sufficient market to support the development
of the potential medical countermeasures and the
maturity of the medical countermeasure pipeline;
``(D) the potential effect of an addition of a
class or category of drug on the potential sale value
of priority review vouchers; and
``(E) such other factors as the Secretary
determines appropriate.
``(3) Duties.--The Secretary, acting through the Assistant
Secretary of Preparedness and Response, shall--
``(A) in coordination with the Assistant Secretary
of Defense for Nuclear, Chemical, and Biological
Defense Program, disclose to interested priority review
applicants the list developed under paragraph (1);
``(B) periodically review the list developed under
paragraph (1) for continued necessity and
appropriateness, and add, amend, or remove any classes
or categories of drugs if no longer necessary or
appropriate; and
``(C) maintain a publicly available archive of the
list over time.
``(4) Transition period.--Before the date of the initial
publication of the list developed under paragraph (1), the most
recent priority list developed under this section before the
date of enactment of the Prioritizing Medical Countermeasures
for National Security Act of 2023 shall remain in effect.''.
(c) GAO Report.--Section 565A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-4a) is amended by inserting after
subsection (g), as redesignated by subsection (b)(1), the following:
``(h) GAO Report.--
``(1) In general.--Not later than September 30, 2027, the
Comptroller General of the United States shall transmit to
Congress a report on the effectiveness of this section in
encouraging the development of the medical countermeasures
needed to protect and prepare for emerging threats to public
health and national security.
``(2) Contents.--The report shall include--
``(A) input from the Secretary of Defense and the
Secretary of Health and Human Services; and
``(B) recommendations of the Comptroller General of
the United States, if any, on necessary modifications
to this section.''.
(d) Sunset.--Subsection (i) of such section, as redesignated by
subsection (b)(1) of this section, is amended--
(1) by striking ``subsection (b)'' and inserting
``subsection (c)''; and
(2) by striking ``October 1, 2023'' and inserting ``October
1, 2029''.
(e) Conforming Amendments To Remove References to Material
Threats.--Section 565A of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb-4a) is amended by striking ``material threat'' each place
it appears in--
(1) subsection (a)(3);
(2) paragraphs (1) and (2) of subsection (c), as
redesignated by subsection (b)(1); and
(3) subsection (f), as so redesignated.
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