Executive order promotes domestic production of medicines, other executive actions

The Trump administration May 5 issued two executive orders on pharmaceutical manufacturing and life-sciences research. The first executive order, "Regulatory Relief to Promote Domestic Production of Critical Medicines," directs the Commissioner of the Food and Drug Administration within 180 days to streamline and accelerate the development of domestic pharmaceutical manufacturing by eliminating unnecessary or duplicative regulations and improving inspection processes. The order similarly directs the Administrator of the Environmental Protection Agency to update regulations and guidance for the inspection and approval of pharmaceutical manufacturing capacity and eliminate duplicative or unnecessary requirements. It also establishes the EPA as the lead agency for the permitting of pharmaceutical manufacturing facilities that require an Environmental Impact Statement and requires the agency to work with other agencies to expedite the review and approval of relevant permits.

The second executive order, “Improving the Safety and Security of Biological Research,” orders the Director of the Office of Science and Technology Policy to immediately establish guidance for the heads of relevant agencies to end federal funding of gain-of-function research and other life-sciences research conducted by certain foreign entities. The order also directs OSTP to replace the “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” within 120 days and replace the “Framework for Nucleic Acid Synthesis Screening” within 90 days. The OSTP is also directed to establish a reporting mechanism for gain-of-function research.