H.R. 1405 — Enhancing Domestic Drug Manufacturing Competitiveness Act

This section provides the short title of the Act as the “Enhancing Domestic Drug Manufacturing Competitiveness Act.”

This section directs the Comptroller General of the United States to conduct a study of the key regulatory barriers that impede the expansion or siting of new pharmaceutical manufacturing facilities in the United States or make the United States less competitive than other countries for such facilities. As background, pharmaceutical manufacturing facilities produce prescription drugs and other medicines used in the U.S. health care system. The study must assess the identified barriers on a time and cost basis and consider: (1) whether environmental or other regulations significantly delay and increase manufacturers’ costs for expanding or siting pharmaceutical facilities in the United States relative to other countries; (2) the potential impact of environmental and other regulations on pharmaceutical supply chain resiliency; and (3) specific regulatory actions, such as expediting reviews, inspections, and approvals of new facilities or changes to existing facilities, that could address the barriers. The Comptroller General also must engage stakeholders to identify and assess the barriers, determine whether promising technological solutions, including manufacturing processes, could address the barriers, and identify the policies needed to support and foster any such solutions. Not later than 1 year after the date of enactment, the Comptroller General must complete the study and submit a report to Congress that identifies and assesses the barriers, addresses each required question, and includes recommendations for streamlining the barriers and facilitating technological solutions to foster increased pharmaceutical manufacturing in the United States.