Enhancing Domestic Drug Manufacturing Competitiveness Act
The Enhancing Domestic Drug Manufacturing Competitiveness Act would require the Comptroller General (GAO) to conduct a comprehensive study to identify the key regulatory barriers that hinder the expansion or siting of new pharmaceutical manufacturing facilities in the United States. The study would compare U.S. regulatory burdens with those in other countries on a time-and-cost basis, examine how these regulations affect pharmaceutical supply chain resiliency, and assess possible actions regulators could take to address the barriers (such as expediting reviews, inspections, and approvals). It would also involve stakeholders to identify promising technological solutions and the policies needed to support them. A final report, including recommendations to streamline regulations and promote manufacturing, would be due within one year of enactment.
Key Points
- 1The bill directs GAO to identify and assess regulatory barriers that impede expansion or siting of U.S. pharmaceutical manufacturing and to assess competitiveness relative to other countries.
- 2It requires analysis of whether environmental or other regulations significantly delay or raise costs for expanding or siting facilities in the U.S. compared with other countries.
- 3It requires evaluation of how these regulations affect pharmaceutical supply chain resiliency.
- 4It calls for identifying concrete regulatory actions (e.g., expediting reviews, inspections, approvals) that could address the barriers.
- 5It mandates stakeholder engagement to identify barriers, potential technological solutions, and policies needed to support those solutions; GAO must deliver a comprehensive report with recommendations within one year of enactment.