STAT+: Trump signs order in bid to boost pharma manufacturing in the U.S.
Federal agencies, including the FDA and the EPA, were ordered to accelerate approval of domestic manufacturing plants.
Amid ongoing anticipation over tariffs on pharmaceuticals, President Trump on Monday signed an executive order designed to lower regulatory hurdles and make it faster for drug companies to manufacture their products in the U.S. The move also includes plans to place more pressure on foreign drugmakers to comply with quality control inspections.
At the top of the list is a mandate for the Food and Drug Administration to reduce the amount of time it takes to approve domestic pharmaceutical manufacturing plants. The agency is being directed to eliminate “duplicative and unnecessary requirements,” streamline reviews, and work with “domestic manufacturers to provide support before facilities start functioning.” Goals were not mentioned in the order.
At the same time, the Environmental Protection Agency was ordered to accelerate its approval of construction of facilities for manufacturing medicines, active pharmaceutical ingredients and related raw materials. And federal agencies issuing permits for a domestic manufacturing facility must designate a single point-of-contact to coordinate permits with support from the White House Office of Management and Budget.
