Us Congress 2023-2024 Regular Session

Us Congress Senate Bill SB4635 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	II
2	2	118THCONGRESS
3	3	2
4	4	DSESSION S. 4635
5	5	To require a report and updated guidance on continued risk management
6	6	for pharmaceutical supply chains of Department of Defense.
7	7	IN THE SENATE OF THE UNITED STATES
8	8	JULY8, 2024
9	9	Mr. P
10	10	ETERS(for himself and Ms. ERNST) introduced the following bill; which
11	11	was read twice and referred to the Committee on Armed Services
12	12	A BILL
13	13	To require a report and updated guidance on continued
14	14	risk management for pharmaceutical supply chains of
15	15	Department of Defense.
16	16	Be it enacted by the Senate and House of Representa-1
17	17	tives of the United States of America in Congress assembled, 2
18	18	SECTION 1. SHORT TITLE. 3
19	19	This Act may be cited as the ‘‘Pharmaceutical Risk 4
20	20	Assessment and Mitigation Act of 2024’’. 5
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23	23	•S 4635 IS
24	24	SEC. 2. REPORT AND UPDATED GUIDANCE ON CONTINUED 1
25	25	RISK MANAGEMENT FOR PHARMACEUTICAL 2
26	26	SUPPLY CHAINS OF DEPARTMENT OF DE-3
27	27	FENSE. 4
28	28	(a) I
29	29	NGENERAL.—Not later than two years after the 5
30	30	date of the enactment of this Act, the Under Secretary 6
31	31	of Defense for Acquisition and Sustainment shall— 7
32	32	(1) submit to the Committees on Armed Serv-8
33	33	ices of the Senate and the House of Representatives 9
34	34	a report regarding— 10
35	35	(A) existing information streams within 11
36	36	the Federal Government, if any, for excipients 12
37	37	and key starting materials of drugs that may be 13
38	38	used to assess the reliance by the Department 14
39	39	of Defense on high-risk foreign suppliers ana-15
40	40	lyzed in the report required under section 16
41	41	860(a) of the James M. Inhofe National De-17
42	42	fense Authorization Act for Fiscal Year 2023 18
43	43	(Public Law 117–263; 10 U.S.C. 3241 note 19
44	44	prec.); 20
45	45	(B) active pharmaceutical ingredients, final 21
46	46	drug products, and respective excipients and 22
47	47	key starting materials analyzed in such report 23
48	48	that is produced by each manufacturer in a 24
49	49	high-risk foreign country, as determined by the 25
50	50	Secretary of Defense; 26
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54	54	(C) any limitations on the ability of the 1
55	55	Secretary to— 2
56	56	(i) obtain or analyze the information 3
57	57	identified under subparagraphs (A) and 4
58	58	(B); and 5
59	59	(ii) use data analytics to monitor 6
60	60	vulnerabilities in the pharmaceutical supply 7
61	61	chain of the Department; 8
62	62	(D) how the Secretary plans to address the 9
63	63	limitations identified under subparagraph (C); 10
64	64	and 11
65	65	(E) any recommendations of the Secretary 12
66	66	to address those limitations; and 13
67	67	(2) update risk management guidance developed 14
68	68	by the Under Secretary under section 860(a)(1) of 15
69	69	the James M. Inhofe National Defense Authoriza-16
70	70	tion Act for Fiscal Year 2023 (Public Law 117–263; 17
71	71	10 U.S.C. 3241 note prec.) to include any relevant 18
72	72	findings identified in paragraph (1). 19
73	73	(b) FDA D
74	74	ETERMINATIONS.—The Department of 20
75	75	Defense shall rely upon determinations of excipients and 21
76	76	key starting materials for final drug products that are 22
77	77	made by the Food and Drug Administration (FDA) or 23
78	78	that align with FDA regulations. 24
79	79	Æ
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