PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Version 00 · Introduced in House · Feb 18, 2025
Enhancing Domestic Drug Manufacturing Competitiveness Act
This bill requires the Government Accountability Office (GAO) to study and report to Congress on key regulatory barriers to pharmaceutical manufacturing in the United States.
Specifically, GAO must identify and assess, including by engaging stakeholders, barriers that impede expansion or siting of pharmaceutical manufacturing facilities in the United States or make the United States less competitive than other countries as a location for such facilities. GAO must consider (1) whether environmental or other regulations significantly delay and increase the cost of expanding or siting pharmaceutical manufacturing facilities in the United States; (2) the potential impact of environmental and other regulations on pharmaceutical supply chain resiliency; and (3) specific actions for regulators to address the identified barriers.
Finally, the report must include recommendations for streamlining regulatory barriers and facilitating technological solutions to foster U.S. pharmaceutical manufacturing.
People & committees
Rep. Buchanan, Vern [R-FL-16] · R–FL
Legislative record
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Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Jul 30, 2025. Consult Congress.gov for the current record.
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PlainBill explanation
Based on the full Introduced in House · 2025-02-18 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
This bill would require the Comptroller General to study regulatory obstacles to building or expanding drug manufacturing facilities in the United States. The study would examine time, costs and competitiveness, with input from stakeholders. Congress would receive findings and recommendations within one year after enactment; the bill proposes a study rather than changes to regulatory requirements.
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.
In conducting the study under subsection (a), the Comptroller General shall engage stakeholders
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.
(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.
Section 1 would name the bill the Enhancing Domestic Drug Manufacturing Competitiveness Act.
This Act may be cited as the Enhancing Domestic Drug Manufacturing Competitiveness Act.
The study would examine whether environmental or other regulations significantly delay facility development and increase manufacturers’ costs compared with other countries. It would also examine potential effects on the pharmaceutical supply chain’s ability to withstand disruptions. These are questions for the study, not established findings.
(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?
The study would consider actions regulators could take to address barriers, including faster reviews, inspections and approvals for new facilities or changes to existing ones. This directs the study to consider those actions; it does not require regulators to adopt them.
In conducting the study under subsection (a), the Comptroller General shall consider the following questions:
(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)?
The Comptroller General would have to engage stakeholders to assess regulatory barriers, identify promising technologies or manufacturing processes that could address them, and identify policies needed to support those solutions.
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).
The study and report to Congress would be due within one year after enactment. The report would have to assess barriers in terms of time and cost, answer every required study question, and recommend ways to streamline barriers and facilitate technological solutions. Increasing domestic drug manufacturing is the stated aim of those recommendations, not a guaranteed result.
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.
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.
The supplied actions snapshot, updated July 30, 2025, records introduction in the House and referral to the House Committee on Energy and Commerce on February 18, 2025.
Source snapshot updated 2025-07-30T21:27:37Z. 2025-02-18: Referred to the House Committee on Energy and Commerce. 2025-02-18: Introduced in House
A closer look
Reviewed version: Introduced in House · 2025-02-18. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy change attached to appropriations was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials; formal earmark status in accompanying materials cannot be assessed from this bundle.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No materially narrow carve-out, special exemption or preferential treatment was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Full text preserved for this analysis. Legislative record snapshot: Jul 30, 2025. How PlainBill uses AI