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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1122 Introduced in Senate (IS)]

<DOC>

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.
                                 <all>
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