
President Trump Executive Order Targets Regulatory Barriers to Domestic Pharmaceutical Manufacturing
This week, President Donald J. Trump announced a series of actions aimed at reducing regulatory barriers to domestic pharmaceutical manufacturing. Key points from the White House include:
- Streamlining FDA Approval Processes: President Trump signed an Executive Order directing the U.S. Food and Drug Administration (FDA) to expedite the approval of domestic pharmaceutical manufacturing plants by eliminating unnecessary requirements, streamlining reviews, and collaborating with manufacturers before facilities become operational, according to Reuters.
- Enhancing Oversight of Foreign Manufacturers: The Order mandates increased inspections and higher fees for foreign manufacturing plants. It also directs the FDA to improve enforcement of active pharmaceutical ingredient source reporting by foreign drug producers and consider publicly listing non-compliant facilities.
- Accelerating Facility Construction: The Environmental Protection Agency (EPA) is tasked with expediting the construction of facilities designed to manufacture prescription drugs and their essential raw materials.
- Coordinating Permitting Processes: Federal agencies issuing permits for domestic pharmaceutical manufacturing facilities are required to designate a single point of contact to coordinate applications, ensuring an efficient and coordinated process with support from the White House Office of Management and Budget.
These actions are part of President Trump's broader initiative to strengthen the U.S. pharmaceutical supply chain and reduce dependence on foreign sources for essential medicines.
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