II
118THCONGRESS
2
DSESSION S. 4635
To require a report and updated guidance on continued risk management
for pharmaceutical supply chains of Department of Defense.
IN THE SENATE OF THE UNITED STATES
JULY8, 2024
Mr. P
ETERS(for himself and Ms. ERNST) introduced the following bill; which
was read twice and referred to the Committee on Armed Services
A BILL
To require a report and updated guidance on continued
risk management for pharmaceutical supply chains of
Department of Defense.
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 ‘‘Pharmaceutical Risk 4
Assessment and Mitigation Act of 2024’’. 5
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•S 4635 IS
SEC. 2. REPORT AND UPDATED GUIDANCE ON CONTINUED 1
RISK MANAGEMENT FOR PHARMACEUTICAL 2
SUPPLY CHAINS OF DEPARTMENT OF DE-3
FENSE. 4
(a) I
NGENERAL.—Not later than two years after the 5
date of the enactment of this Act, the Under Secretary 6
of Defense for Acquisition and Sustainment shall— 7
(1) submit to the Committees on Armed Serv-8
ices of the Senate and the House of Representatives 9
a report regarding— 10
(A) existing information streams within 11
the Federal Government, if any, for excipients 12
and key starting materials of drugs that may be 13
used to assess the reliance by the Department 14
of Defense on high-risk foreign suppliers ana-15
lyzed in the report required under section 16
860(a) of the James M. Inhofe National De-17
fense Authorization Act for Fiscal Year 2023 18
(Public Law 117–263; 10 U.S.C. 3241 note 19
prec.); 20
(B) active pharmaceutical ingredients, final 21
drug products, and respective excipients and 22
key starting materials analyzed in such report 23
that is produced by each manufacturer in a 24
high-risk foreign country, as determined by the 25
Secretary of Defense; 26
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(C) any limitations on the ability of the 1
Secretary to— 2
(i) obtain or analyze the information 3
identified under subparagraphs (A) and 4
(B); and 5
(ii) use data analytics to monitor 6
vulnerabilities in the pharmaceutical supply 7
chain of the Department; 8
(D) how the Secretary plans to address the 9
limitations identified under subparagraph (C); 10
and 11
(E) any recommendations of the Secretary 12
to address those limitations; and 13
(2) update risk management guidance developed 14
by the Under Secretary under section 860(a)(1) of 15
the James M. Inhofe National Defense Authoriza-16
tion Act for Fiscal Year 2023 (Public Law 117–263; 17
10 U.S.C. 3241 note prec.) to include any relevant 18
findings identified in paragraph (1). 19
(b) FDA D
ETERMINATIONS.—The Department of 20
Defense shall rely upon determinations of excipients and 21
key starting materials for final drug products that are 22
made by the Food and Drug Administration (FDA) or 23
that align with FDA regulations. 24
Æ
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