Executive order to elevate US pharma manufacturing signed by Trump

On Monday, May 5, US President Trump signed an executive order to reduce regulatory barriers for domestic US pharmaceutical manufacturing, including key ingredients and materials for manufacturing prescription drugs.

The order aims to restore robust domestic manufacturing in the US, with directions for the US FDA to streamline regulatory reviews and provide early support for domestic manufacturers. The order also includes other directives such as allowing the Environmental Protection Agency to accelerate the construction of facilities for prescription drug, API, and raw materials manufacturing, and ensuring federal agencies issue permits for domestic pharmaceutical manufacturing facilities. The US FDA will also be directed to improve the reporting of active ingredients sourced from foreign producers, with considerations to “publicly display a list of facilities that do not comply”.

FDA Commissioner Marty Makary stated that with the signing of the executive order, the federal agency will plan to conduct surprise inspections of overseas plants in order to bring the oversight of such facilities in line with US policies and interests. On estimates from analysts that bringing a new manufacturing facility to the US could take at least 5 years, the White House stated that such a timeline was “unacceptable from a national security standpoint”. Trump stated, “As we invest in the future, we will permanently bring our medical supply chains back home. We will produce our medical supplies, pharmaceuticals, and treatments right here in the United States”.

As the threat of tariffs on imported pharmaceuticals has yet to clarify what such procedures will look like, Trump commented at the signing of the order that an announcement could be made in the next 2 weeks. Currently, the US imports over US$200 billion worth of prescription drugs and related materials.

Sources:

1. Trump signs executive order to encourage US drug manufacturing [Accessed May 7, 2025] https://www.reuters.com/business/healthcare-pharmaceuticals/trump-sign-order-encourage-domestic-drug-manufacturing-wapo-reports-2025-05-05/

2. Fact Sheet: President Donald J. Trump Announces Actions to Reduce Regulatory Barriers to Domestic Pharmaceutical Manufacturing [Accessed May 7, 2025] https://www.whitehouse.gov/fact-sheets/2025/05/fact-sheet-president-donald-j-trump-announces-actions-to-reduce-regulatory-barriers-to-domestic-pharmaceutical-manufacturing/