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.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This bill, titled the "Enhancing Domestic Drug Manufacturing Competitiveness Act," directs the Government Accountability Office (GAO) to conduct a comprehensive study examining why it is difficult and expensive to build or expand pharmaceutical manufacturing facilities in the United States. The study must be completed within one year and include recommendations for reducing regulatory barriers.
Who Benefits and How
Pharmaceutical manufacturers stand to benefit if this study leads to regulatory streamlining. Companies like Pfizer, Johnson & Johnson, and generic drug makers could see reduced costs and faster timelines for building new U.S. factories. Domestic pharmaceutical supply chain companies (equipment suppliers, chemical producers) could also benefit from increased domestic production if regulatory barriers are reduced.
Who Bears the Burden and How
The GAO must allocate staff and resources to complete this study within one year, including engaging with industry stakeholders. Regulatory agencies like the EPA and FDA may face pressure to change their processes based on the study's recommendations. Taxpayers bear the cost of the GAO study, though it is relatively modest.
Key Provisions
- Requires GAO to identify and assess (on a time and cost basis) key regulatory barriers to pharmaceutical manufacturing in the U.S.
- Mandates examination of whether environmental regulations cause delays and increased costs compared to other countries
- Requires GAO to engage stakeholders including pharmaceutical manufacturers to identify barriers and technological solutions
- Study must assess impact of regulations on pharmaceutical supply chain resiliency
- GAO must submit recommendations to Congress for streamlining regulatory barriers within one year
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
This bill directs the Comptroller General of the United States to conduct a study assessing regulatory barriers hindering the expansion or siting of new pharmaceutical manufacturing facilities in the U.S., and to provide recommendations for streamlining these barriers.
Key Policy Areas
Healthcare, Commerce
Primary Purpose
This bill directs the Comptroller General of the United States to conduct a study assessing regulatory barriers hindering the expansion or siting of new pharmaceutical manufacturing facilities in the U.S., and to provide recommendations for streamlining these barriers.
Policy Domains
Sponsors
Legislative Progress
IntroducedMr. Buchanan (for himself and Mr. Donalds) introduced the following …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "the_comptroller_general"
- → Comptroller General of the United States
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
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