I 
119TH CONGRESS 
1ST SESSION H. R. 1405 
To direct the Comptroller General of the United States to conduct a study 
to assess the key regulatory barriers that impede the expansion or siting 
of new pharmaceutical manufacturing facilities in the United States, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 18, 2025 
Mr. BUCHANAN (for himself and Mr. DONALDS) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To direct the Comptroller General of the United States to 
conduct a study to assess the key regulatory barriers 
that impede the expansion or siting of new pharma-
ceutical manufacturing facilities in the United States, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Enhancing Domestic 
Drug Manufacturing Competitiveness Act’’. 
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SEC. 2. STUDY ON KEY REGULATORY BARRIERS TO EX-
PANDING 
PHARMACEUTICAL 
MANUFAC-
TURING IN THE UNITED STATES. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study to identify, and to 
assess on a time and cost basis, the key regulatory barriers 
that— 
(1) impede the expansion or siting of new phar-
maceutical manufacturing facilities in the United 
States; or 
(2) make the United States less competitive 
than other countries as a location for such facilities. 
(b) QUESTIONS.—In conducting the study under sub-
section (a), the Comptroller General shall consider the fol-
lowing questions: 
(1) Do environmental or other regulations sig-
nificantly delay, and increase the costs for manufac-
turers of, expanding or siting pharmaceutical manu-
facturing facilities in the United States relative to 
environmental or other regulations in other coun-
tries? 
(2) What is the potential impact of environ-
mental and other regulations on pharmaceutical sup-
ply chain resiliency? 
(3) What specific actions (such as expediting 
reviews, inspections, and approvals of new facilities 
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or changes to existing facilities) could be taken by 
regulators to address the regulatory barriers de-
scribed in subsection (a)? 
(c) ENGAGING STAKEHOLDERS.—In conducting the 
study under subsection (a), the Comptroller General shall 
engage stakeholders— 
(1) to identify and assess the barriers described 
in subsection (a); 
(2) to identify whether there are promising 
technological solutions, including manufacturing 
processes, that could help to address the regulatory 
barriers described in subsection (a); and 
(3) to identify the policies needed to support 
and foster any solutions identified pursuant to para-
graph (2). 
(d) REPORT.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Comptroller 
General shall complete the study under subsection 
(a) and submit to the Congress a report on the re-
sults of such study. 
(2) CONTENTS.—The report required by para-
graph (1) shall— 
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(A) identify, and assess on a time and cost 
basis, the regulatory barriers described in sub-
section (a); 
(B) address each question listed in sub-
section (b); and 
(C) include recommendations for stream-
lining the regulatory barriers described in sub-
section (a), and facilitating the use of techno-
logical solutions described in subsection (c)(2), 
to foster increased pharmaceutical manufac-
turing in the United States. 
Æ 
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