Us Congress 2025-2026 Regular Session

Us Congress House Bill HB1405 Compare Versions

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

Old	New	Differences
1	1	I
2	2	119THCONGRESS
3	3	1
4	4	STSESSION H. R. 1405
5	5	To direct the Comptroller General of the United States to conduct a study
6	6	to assess the key regulatory barriers that impede the expansion or siting
7	7	of new pharmaceutical manufacturing facilities in the United States,
8	8	and for other purposes.
9	9	IN THE HOUSE OF REPRESENTATIVES
10	10	FEBRUARY18, 2025
11	11	Mr. B
12	12	UCHANAN(for himself and Mr. DONALDS) introduced the following bill;
13	13	which was referred to the Committee on Energy and Commerce
14	14	A BILL
15	15	To direct the Comptroller General of the United States to
16	16	conduct a study to assess the key regulatory barriers
17	17	that impede the expansion or siting of new pharma-
18	18	ceutical manufacturing facilities in the United States,
19	19	and for other purposes.
20	20	Be it enacted by the Senate and House of Representa-1
21	21	tives of the United States of America in Congress assembled, 2
22	22	SECTION 1. SHORT TITLE. 3
23	23	This Act may be cited as the ‘‘Enhancing Domestic 4
24	24	Drug Manufacturing Competitiveness Act’’. 5
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27	27	•HR 1405 IH
28	28	SEC. 2. STUDY ON KEY REGULATORY BARRIERS TO EX-1
29	29	PANDING PHARMACEUTICAL MANUFAC-2
30	30	TURING IN THE UNITED STATES. 3
31	31	(a) I
32	32	NGENERAL.—The Comptroller General of the 4
33	33	United States shall conduct a study to identify, and to 5
34	34	assess on a time and cost basis, the key regulatory barriers 6
35	35	that— 7
36	36	(1) impede the expansion or siting of new phar-8
37	37	maceutical manufacturing facilities in the United 9
38	38	States; or 10
39	39	(2) make the United States less competitive 11
40	40	than other countries as a location for such facilities. 12
41	41	(b) Q
42	42	UESTIONS.—In conducting the study under sub-13
43	43	section (a), the Comptroller General shall consider the fol-14
44	44	lowing questions: 15
45	45	(1) Do environmental or other regulations sig-16
46	46	nificantly delay, and increase the costs for manufac-17
47	47	turers of, expanding or siting pharmaceutical manu-18
48	48	facturing facilities in the United States relative to 19
49	49	environmental or other regulations in other coun-20
50	50	tries? 21
51	51	(2) What is the potential impact of environ-22
52	52	mental and other regulations on pharmaceutical sup-23
53	53	ply chain resiliency? 24
54	54	(3) What specific actions (such as expediting 25
55	55	reviews, inspections, and approvals of new facilities 26
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58	58	•HR 1405 IH
59	59	or changes to existing facilities) could be taken by 1
60	60	regulators to address the regulatory barriers de-2
61	61	scribed in subsection (a)? 3
62	62	(c) E
63	63	NGAGINGSTAKEHOLDERS.—In conducting the 4
64	64	study under subsection (a), the Comptroller General shall 5
65	65	engage stakeholders— 6
66	66	(1) to identify and assess the barriers described 7
67	67	in subsection (a); 8
68	68	(2) to identify whether there are promising 9
69	69	technological solutions, including manufacturing 10
70	70	processes, that could help to address the regulatory 11
71	71	barriers described in subsection (a); and 12
72	72	(3) to identify the policies needed to support 13
73	73	and foster any solutions identified pursuant to para-14
74	74	graph (2). 15
75	75	(d) R
76	76	EPORT.— 16
77	77	(1) I
78	78	N GENERAL.—Not later than 1 year after 17
79	79	the date of enactment of this Act, the Comptroller 18
80	80	General shall complete the study under subsection 19
81	81	(a) and submit to the Congress a report on the re-20
82	82	sults of such study. 21
83	83	(2) C
84	84	ONTENTS.—The report required by para-22
85	85	graph (1) shall— 23
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88	88	•HR 1405 IH
89	89	(A) identify, and assess on a time and cost 1
90	90	basis, the regulatory barriers described in sub-2
91	91	section (a); 3
92	92	(B) address each question listed in sub-4
93	93	section (b); and 5
94	94	(C) include recommendations for stream-6
95	95	lining the regulatory barriers described in sub-7
96	96	section (a), and facilitating the use of techno-8
97	97	logical solutions described in subsection (c)(2), 9
98	98	to foster increased pharmaceutical manufac-10
99	99	turing in the United States. 11
100	100	Æ
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