What This Bill Does
This bill improves the program that gives priority review to drug applications for medicines that treat diseases caused by chemical, biological, radiological, or nuclear agents. It expands what drugs qualify for this fast-track review and requires the government to create and maintain a list of drug categories that address national security threats.
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Who It Affects
- Drug manufacturers developing treatments for diseases caused by chemical, biological, radiological, or nuclear agents
- The Assistant Secretary of Preparedness and Response (a federal official)
- The Secretary of Defense
- Congress
- The Comptroller General of the United States (the government's chief auditor)
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Key Provisions
- The government will create and maintain a list of drug categories needed to prevent or treat diseases caused by chemical, biological, radiological, or nuclear agents that could threaten public health or national security. (Sec. 2(b)(1))
- The Assistant Secretary of Preparedness and Response must work with the Public Health Emergency Medical Enterprise (an established government organization) and the Secretary of Defense to decide which drugs go on this list. (Sec. 2(b)(1))
- The government must regularly review the list, add new drugs if necessary, remove drugs if they are no longer needed, and keep a public record of all past versions of the list. (Sec. 2(b)(3))
- A government auditor must report to Congress by September 30, 2027 about whether this program successfully encouraged development of needed medicines for public health and national security threats. (Sec. 2(c))
- A previous version of this list stays in effect until the government publishes the new list required by this bill. (Sec. 2(b)(4))
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What Changes
The term "material threat" is removed from the definition of which drugs qualify for priority review, broadening the types of drugs that can receive this faster approval process. Drugs that treat diseases caused by chemical, biological, radiological, or nuclear agents now qualify if they are on the government's list, regardless of whether the threat is labeled "material."
The deadline for the program to end moves from October 1, 2023 to October 1, 2029.
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Important Definitions
- Medical countermeasure: A human drug application for a drug labeled to prevent or treat a disease or condition specifically caused by a chemical, biological, radiological, or nuclear agent (an extremely dangerous substance or organism)
- Priority review voucher: A ticket that allows a drug company to have its drug application reviewed faster by the government
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Effective Date
Not specified in bill text
II
118TH CONGRESS
1ST SESSION
S. 1122
To improve the program to provide for priority review of human drug applica-
tions 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 Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Prioritizing Medical
4
Countermeasures for National Security Act of 2023’’.
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•S 1122 IS
SEC. 2. EXTENSION AND EXPANSION OF MEDICAL COUN-
1
TERMEASURE PRIORITY REVIEW VOUCHER
2
PROGRAM.
3
(a) DEFINITION OF MEDICAL COUNTERMEASURE AP-
4
PLICATION.—Subsection (a)(4) of section 565A of the
5
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
6
360bbb–4a) is amended—
7
(1) in the paragraph heading, by striking ‘‘MA-
8
TERIAL THREAT MEDICAL’’ and inserting ‘‘MED-
9
ICAL’’;
10
(2) in the matter preceding subparagraph (A),
11
by striking ‘‘material threat’’; and
12
(3) by amending subparagraph (A) to read as
13
follows:
14
‘‘(A) is a human drug application for a
15
drug that is—
16
‘‘(i) labeled for an indication to pre-
17
vent or treat a disease or condition specifi-
18
cally caused by a chemical, biological, radi-
19
ological, or nuclear agent; and
20
‘‘(ii) part of a class or category of
21
drug on the list described in subsection (b)
22
at the time of approval of the applica-
23
tion.’’.
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(b) LIST OF MEDICAL COUNTERMEASURES FOR NA-
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TIONAL SECURITY THREATS.—Section 565A of the Fed-
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•S 1122 IS
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–
1
4a) is amended—
2
(1) by redesignating subsections (b) through (g)
3
as subsections (c) through (g) and (i), respectively;
4
and
5
(2) by inserting after subsection (a), the fol-
6
lowing:
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‘‘(b) LIST OF MEDICAL COUNTERMEASURES FOR NA-
8
TIONAL SECURITY THREATS.—
9
‘‘(1) IN
GENERAL.—The Secretary, acting
10
through the Assistant Secretary of Preparedness and
11
Response, in consultation with the Public Health
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Emergency Medical Enterprise established under
13
section 2801 of the Public Health Service Act, in-
14
cluding the Secretary of Defense, shall establish and
15
maintain a list of potentially eligible classes and cat-
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egories of drugs that are identified as necessary to
17
prevent or treat the diseases and conditions specifi-
18
cally caused by a chemical, biological, radiological, or
19
nuclear agent that—
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‘‘(A) has the potential to lead to a public
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health emergency with significant potential to
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affect national security; or
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‘‘(B) may present a specific threat to the
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Armed Forces.
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•S 1122 IS
‘‘(2) FACTORS.—In establishing and revising
1
the list under paragraph (1), the Secretary may con-
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sider—
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‘‘(A) whether an eligible class or category
4
of drugs that is identified is—
5
‘‘(i) needed to protect the public
6
health, using the same standard that ap-
7
plies with respect to determinations of ma-
8
terial
threats
under
section
319F–
9
2(c)(2)(B)(ii) of the Public Health Service
10
Act; and
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‘‘(ii) determined to be a priority (con-
12
sistent with sections 302(2) and 304(a) of
13
the Homeland Security Act of 2002);
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‘‘(B) for any class or category of drugs
15
under consideration to address specific threats
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to the Armed Forces, information provided by
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the Secretary of Defense to help evaluate
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whether a priority review voucher is necessary
19
and beneficial to incentivize product develop-
20
ment for the Department of Defense use and
21
fielding;
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‘‘(C) whether the class or category of drug
23
requires incentivization in the form a priority
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review voucher based upon economic factors,
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•S 1122 IS
such as whether there is a sufficient market to
1
support the development of the potential med-
2
ical countermeasures and the maturity of the
3
medical countermeasure pipeline;
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‘‘(D) the potential effect of an addition of
5
a class or category of drug on the potential sale
6
value of priority review vouchers; and
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‘‘(E) such other factors as the Secretary
8
determines appropriate.
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‘‘(3) DUTIES.—The Secretary, acting through
10
the Assistant Secretary of Preparedness and Re-
11
sponse, shall—
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‘‘(A) in coordination with the Assistant
13
Secretary of Defense for Nuclear, Chemical,
14
and Biological Defense Program, disclose to in-
15
terested priority review applicants the list devel-
16
oped under paragraph (1);
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‘‘(B) periodically review the list developed
18
under paragraph (1) for continued necessity
19
and appropriateness, and add, amend, or re-
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move any classes or categories of drugs if no
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longer necessary or appropriate; and
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‘‘(C) maintain a publicly available archive
23
of the list over time.
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•S 1122 IS
‘‘(4) TRANSITION PERIOD.—Before the date of
1
the initial publication of the list developed under
2
paragraph (1), the most recent priority list devel-
3
oped under this section before the date of enactment
4
of the Prioritizing Medical Countermeasures for Na-
5
tional Security Act of 2023 shall remain in effect.’’.
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(c) GAO REPORT.—Section 565A of the Federal
7
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–4a) is
8
amended by inserting after subsection (g), as redesignated
9
by subsection (b)(1), the following:
10
‘‘(h) GAO REPORT.—
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‘‘(1) IN GENERAL.—Not later than September
12
30, 2027, the Comptroller General of the United
13
States shall transmit to Congress a report on the ef-
14
fectiveness of this section in encouraging the devel-
15
opment of the medical countermeasures needed to
16
protect and prepare for emerging threats to public
17
health and national security.
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‘‘(2) CONTENTS.—The report shall include—
19
‘‘(A) input from the Secretary of Defense
20
and the Secretary of Health and Human Serv-
21
ices; and
22
‘‘(B) recommendations of the Comptroller
23
General of the United States, if any, on nec-
24
essary modifications to this section.’’.
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•S 1122 IS
(d) SUNSET.—Subsection (i) of such section, as re-
1
designated by subsection (b)(1) of this section, is amend-
2
ed—
3
(1) by striking ‘‘subsection (b)’’ and inserting
4
‘‘subsection (c)’’; and
5
(2) by striking ‘‘October 1, 2023’’ and inserting
6
‘‘October 1, 2029’’.
7
(e) CONFORMING AMENDMENTS TO REMOVE REF-
8
ERENCES TO MATERIAL THREATS.—Section 565A of the
9
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
10
360bbb–4a) is amended by striking ‘‘material threat’’ each
11
place it appears in—
12
(1) subsection (a)(3);
13
(2) paragraphs (1) and (2) of subsection (c), as
14
redesignated by subsection (b)(1); and
15
(3) subsection (f), as so redesignated.
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Æ
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