Trump Signs EO Strengthening Domestic Pharmaceutical Production

On May 5, 2025, President Donald J. Trump issued an Executive Order (EO) to address harsh lessons learned by the nation during the COVID pandemic.

The EO, "Regulatory Relief to Promote Domestic Production of Critical Medicines,” intends to strengthen the United States' pharmaceutical manufacturing capabilities by reducing regulatory barriers and expediting facility development.

The COVID pandemic exposed critical supply chain issues, especially with regards to China being the principle supplier of essential supplies such as personal protective equipment (PPE) and pharmaceutical base components. The EO seeks to remedy that reliance on potentially hostile foreign providers by encouraging domestic production of essential medicines.

The EO is consistent with the administration’s stated goals of restoring American manufacturing capabilities, creating American jobs, and protecting the nation’s security interests.

Key Provisions of the EO include:

1. FDA Process Streamlining: The Food and Drug Administration (FDA) is mandated to review and eliminate redundant or unnecessary regulations within 180 days. The goal is to enhance the timeliness and predictability of agency reviews, thereby accelerating the development of domestic pharmaceutical manufacturing.
2. Enhanced Oversight of Foreign Manufacturers: The FDA is directed to improve enforcement of active-ingredient source reporting by foreign producers. This includes considering public disclosure of facilities that fail to comply with U.S. standards.
3. EPA's Role in Facility Construction: The Environmental Protection Agency (EPA) is instructed to expedite the construction of pharmaceutical manufacturing facilities, addressing environmental permitting processes that may delay development.

President Trump emphasized the urgency of reducing the typical five to ten-year timeline for building new pharmaceutical manufacturing capacity, citing national security concerns. He 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."

The President discussed efforts during his first administration to restore America’s ability to produce critical medications domestically, including his August, 2020 EO 13944, which directed executive departments and agencies to act to increase their domestic procurement of essential medicines. He criticized the previous administration for failing to advance these goals, pointing out that “critical barriers and information gaps persist in establishing a domestic, resilient, and affordable pharmaceutical supply chain for American patients.“

In response to the administration's policy shifts, major pharmaceutical companies such as Roche, Novartis, Eli Lilly, Johnson & Johnson and Bristol Meyers have announced significant investments in U.S. manufacturing.

The full text of the EO may be found HERE.