II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prioritizing Medical 

5 Countermeasures for National Security Act of 2023’’. 


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1 SEC. 2. EXTENSION AND EXPANSION OF MEDICAL COUN2 TERMEASURE PRIORITY REVIEW VOUCHER 

3 PROGRAM. 

4 (a) DEFINITION OF MEDICAL COUNTERMEASURE AP5 PLICATION.—Subsection (a)(4) of section 565A of the 

6 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

7 360bbb–4a) is amended— 

8 (1) in the paragraph heading, by striking ‘‘MA9 TERIAL THREAT MEDICAL’’ and inserting ‘‘MED10 ICAL’’; 

11 (2) in the matter preceding subparagraph (A), 

12 by striking ‘‘material threat’’; and 

13 (3) by amending subparagraph (A) to read as 

14 follows: 

15 ‘‘(A) is a human drug application for a 

16 drug that is— 

17 ‘‘(i) labeled for an indication to pre18 vent or treat a disease or condition specifi19 cally caused by a chemical, biological, radi20 ological, or nuclear agent; and 

21 ‘‘(ii) part of a class or category of 

22 drug on the list described in subsection (b) 

23 at the time of approval of the applica24 tion.’’. 

25 (b) LIST OF MEDICAL COUNTERMEASURES FOR NA26 TIONAL SECURITY THREATS.—Section 565A of the FedVerDate Sep 11 2014 03:56 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1122.IS S1122

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1 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb– 

2 4a) is amended— 

3 (1) by redesignating subsections (b) through (g) 

4 as subsections (c) through (g) and (i), respectively; 

5 and 

6 (2) by inserting after subsection (a), the fol7 lowing: 

8 ‘‘(b) LIST OF MEDICAL COUNTERMEASURES FOR NA9 TIONAL SECURITY THREATS.— 

10 ‘‘(1) IN GENERAL.—The Secretary, acting 

11 through the Assistant Secretary of Preparedness and 

12 Response, in consultation with the Public Health 

13 Emergency Medical Enterprise established under 

14 section 2801 of the Public Health Service Act, in15 cluding the Secretary of Defense, shall establish and 

16 maintain a list of potentially eligible classes and cat17 egories of drugs that are identified as necessary to 

18 prevent or treat the diseases and conditions specifi19 cally caused by a chemical, biological, radiological, or 

20 nuclear agent that— 

21 ‘‘(A) has the potential to lead to a public 

22 health emergency with significant potential to 

23 affect national security; or 

24 ‘‘(B) may present a specific threat to the 

25 Armed Forces. 


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1 ‘‘(2) FACTORS.—In establishing and revising 

2 the list under paragraph (1), the Secretary may con3 sider— 

4 ‘‘(A) whether an eligible class or category 

5 of drugs that is identified is— 

6 ‘‘(i) needed to protect the public 

7 health, using the same standard that ap8 plies with respect to determinations of ma9 terial threats under section 319F– 

10 2(c)(2)(B)(ii) of the Public Health Service 

11 Act; and 

12 ‘‘(ii) determined to be a priority (con13 sistent with sections 302(2) and 304(a) of 

14 the Homeland Security Act of 2002); 

15 ‘‘(B) for any class or category of drugs 

16 under consideration to address specific threats 

17 to the Armed Forces, information provided by 

18 the Secretary of Defense to help evaluate 

19 whether a priority review voucher is necessary 

20 and beneficial to incentivize product develop21 ment for the Department of Defense use and 

22 fielding; 

23 ‘‘(C) whether the class or category of drug 

24 requires incentivization in the form a priority 

25 review voucher based upon economic factors, 


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1 such as whether there is a sufficient market to 

2 support the development of the potential med3 ical countermeasures and the maturity of the 

4 medical countermeasure pipeline; 

5 ‘‘(D) the potential effect of an addition of 

6 a class or category of drug on the potential sale 

7 value of priority review vouchers; and 

8 ‘‘(E) such other factors as the Secretary 

9 determines appropriate. 

10 ‘‘(3) DUTIES.—The Secretary, acting through 

11 the Assistant Secretary of Preparedness and Re12 sponse, shall— 

13 ‘‘(A) in coordination with the Assistant 

14 Secretary of Defense for Nuclear, Chemical, 

15 and Biological Defense Program, disclose to in16 terested priority review applicants the list devel17 oped under paragraph (1); 

18 ‘‘(B) periodically review the list developed 

19 under paragraph (1) for continued necessity 

20 and appropriateness, and add, amend, or re21 move any classes or categories of drugs if no 

22 longer necessary or appropriate; and 

23 ‘‘(C) maintain a publicly available archive 

24 of the list over time. 


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1 ‘‘(4) TRANSITION PERIOD.—Before the date of 

2 the initial publication of the list developed under 

3 paragraph (1), the most recent priority list devel4 oped under this section before the date of enactment 

5 of the Prioritizing Medical Countermeasures for Na6 tional Security Act of 2023 shall remain in effect.’’. 

7 (c) GAO REPORT.—Section 565A of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4a) is 

9 amended by inserting after subsection (g), as redesignated 

10 by subsection (b)(1), the following: 

11 ‘‘(h) GAO REPORT.— 

12 ‘‘(1) IN GENERAL.—Not later than September 

13 30, 2027, the Comptroller General of the United 

14 States shall transmit to Congress a report on the ef15 fectiveness of this section in encouraging the devel16 opment of the medical countermeasures needed to 

17 protect and prepare for emerging threats to public 

18 health and national security. 

19 ‘‘(2) CONTENTS.—The report shall include— 

20 ‘‘(A) input from the Secretary of Defense 

21 and the Secretary of Health and Human Serv22 ices; and 

23 ‘‘(B) recommendations of the Comptroller 

24 General of the United States, if any, on nec25 essary modifications to this section.’’. 


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1 (d) SUNSET.—Subsection (i) of such section, as re2 designated by subsection (b)(1) of this section, is amend3 ed— 

4 (1) by striking ‘‘subsection (b)’’ and inserting 

5 ‘‘subsection (c)’’; and 

6 (2) by striking ‘‘October 1, 2023’’ and inserting 

7 ‘‘October 1, 2029’’. 

8 (e) CONFORMING AMENDMENTS TO REMOVE REF9 ERENCES TO MATERIAL THREATS.—Section 565A of the 

10 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

11 360bbb–4a) is amended by striking ‘‘material threat’’ each 

12 place it appears in— 

13 (1) subsection (a)(3); 

14 (2) paragraphs (1) and (2) of subsection (c), as 

15 redesignated by subsection (b)(1); and 

16 (3) subsection (f), as so redesignated. 

Æ 


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