President Trump signs Executive Orders (EOs) related to biological research and pharmaceutical manufacturing.
“Improving the Safety and Security of Biological Research” directs several agencies to significantly increase oversight of gain-of-function research being conducted domestically and coordinate and end federal funding of such research conducted by countries of concern.
Key Provisions:
Immediate suspension of federally funded GoF research in countries deemed to have insufficient oversight, notably China and Iran.
Mandates U.S. research institutions to report dangerous GoF activities, including those funded privately, and comply with new biosafety standards.
Institutes penalties for non-compliance, such as revocation of funding and up to five years of ineligibility for federal life science grants.
“Regulatory Relief to Promote Domestic Production of Critical Medicines” directs the Food and Drug Administration, Environmental Protection Agency, and other agencies to reduce barriers to pharmaceutical manufacturing in the U.S., including permitting reform and reducing regulatory barriers to construction.
Key Provisions:
Directs the FDA and EPA to streamline regulations and expedite approvals for domestic pharmaceutical manufacturing facilities.
Enhances scrutiny of foreign manufacturing facilities and shifts inspection costs to them.
(Biological Safety EO Fact Sheet and Domestic Production EO Fact Sheet, and more at NPR and Healthcare Finance)