Trump Moves to Boost Domestic Pharma Manufacturing with Regulatory Overhaul

President Donald Trump has signed an executive order directing the Food and Drug Administration and the Environmental Protection Agency to reduce regulatory barriers for domestic pharmaceutical manufacturing. The order aims to accelerate the approval process for new drug production facilities in the United States while tightening oversight on foreign manufacturers.

 

Under the new directive, the FDA will streamline its review process for domestic pharmaceutical plants, eliminating duplicative requirements and providing early support to manufacturers before facilities become operational. Additionally, the agency will increase fees and inspections for foreign drug production sites, ensuring stricter compliance with U.S. regulations.

 

The EPA has been tasked with expediting the construction of pharmaceutical manufacturing facilities, including those producing active pharmaceutical ingredients and other essential raw materials. The administration argues that current timelines for building new capacity—estimated at five to ten years—are unacceptable from a national security standpoint.

 

The executive order builds on previous efforts to reduce reliance on foreign drug suppliers and strengthen the domestic pharmaceutical supply chain. Trump has emphasized the need for the U.S. to manufacture its own medicines, citing concerns over potential disruptions in global trade and security risks.

 

Industry analysts suggest that the policy shift could reshape the global pharmaceutical supply chain, particularly affecting Indian and Chinese drug exporters. The FDA’s expanded inspection regime and increased regulatory scrutiny on foreign manufacturers may lead to higher compliance costs and potential disruptions in supply.

 

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Sources: PharmTech, Moneycontrol, Fierce Pharma, Economic Times, White House Fact Sheet.