WASHINGTON (dpa-AFX) - President Donald Trump has signed an Executive Order to facilitate the restoration of a robust domestic manufacturing base for prescription drugs, including key ingredients and materials necessary to manufacture prescription drugs.
The Order directs the U.S. Food and Drug Administration to reduce the amount of time it takes to approve domestic pharmaceutical manufacturing plants by eliminating duplicative and unnecessary requirements, streamlining reviews, and working with domestic manufacturers to provide early support before facilities come online.
The Order directs the FDA to increase fees for and inspections of foreign manufacturing plants.
President Trump is directing the FDA to improve enforcement of active pharmaceutical ingredient source reporting by foreign drug producers and consider publicly displaying a list of facilities that do not comply with it.
The Order directs the Environmental Protection Agency to accelerate the construction of facilities designed to manufacture prescription drugs, active pharmaceutical ingredients, and other necessary raw materials.
The Order ensures that federal agencies issuing permits for a domestic pharmaceutical manufacturing facility designate a single point-of-contact to coordinate permit applications with inter-agency support from the White House Office of Management and Budget to ensure an efficient and coordinated process.
This Order will speed up timelines for building domestic pharmaceutical manufacturing site by reducing regulatory barriers to construction, the White House said.
Estimates suggest that building new manufacturing capacity for pharmaceuticals and critical inputs may take as long as five to ten years.
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