H.R. 1405: 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.

Written by the Congressional Research Service, Library of Congress.