119-hr1405

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1405 Introduced in House

    (IH) ]

<DOC>

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 pharmaceutical manufacturing facilities in the United 
 States, and for other purposes.

 Be it enacted by the Senate and House of Representatives 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''.

SEC. 2. STUDY ON KEY REGULATORY BARRIERS TO EXPANDING PHARMACEUTICAL 
 MANUFACTURING 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 pharmaceutical 
 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 subsection

    (a) , the 
Comptroller General shall consider the following questions:

    (1) Do environmental or other regulations significantly 
 delay, and increase the costs for manufacturers of, expanding 
 or siting pharmaceutical manufacturing facilities in the United 
 States relative to environmental or other regulations in other 
 countries?

    (2) What is the potential impact of environmental and other 
 regulations on pharmaceutical supply chain resiliency?

    (3) What specific actions (such as expediting reviews, 
 inspections, and approvals of new facilities or changes to 
 existing facilities) could be taken by regulators to address 
 the regulatory barriers described 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 paragraph

    (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 results of such study.

    (2) Contents.--The report required by paragraph

    (1) shall--
        (A) identify, and assess on a time and cost basis, 
 the regulatory barriers described in subsection

    (a) ;
        (B) address each question listed in subsection

    (b) ; 
 and
            (C) include recommendations for streamlining the 
 regulatory barriers described in subsection

    (a) , and 
 facilitating the use of technological solutions 
 described in subsection
            (c) (2) , to foster increased 
 pharmaceutical manufacturing in the United States.
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