News

Reshoring EO aims to streamline permitting, approval, and oversight of US drug manufacturing

07 May 2025

On May 5, 2025, President Donald Trump signed an Executive Order (EO) aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”). The EO directs federal agencies to eliminate regulatory hurdles, accelerate permitting, and prioritize domestic facilities to restore the United States’ capacity to manufacture prescription drugs and critical inputs such as active pharmaceutical ingredients (APIs). The primary goals of the executive order are to reduce U.S. reliance on foreign pharmaceutical production, improve national security, and strengthen the domestic drug supply chain. Notably, the EO was signed on the same day as an EO entitled “Improving the Safety and Security of Biological Research,” as part of broader actions to address U.S. national security concerns and strengthen the domestic drug supply chain.

While these EOs signal a potential opportunity for drug manufacturers to invest in U.S.-based production, there are still many considerations to weigh in deciding whether to proceed with an investment in a domestic drug manufacturing facility. Although the EOs might in the future offer greater efficiencies and reduced complexity in the process of building or expanding a U.S. manufacturing site, building or expanding a U.S. drug manufacturing site still involves a significant time and capital investment, and it remains to be seen the full extent to which the actions taken as a result of this EO, together with other incentives including those relating to trade, will result in significant increases in domestic manufacturing investments. Our team has provided a summary of key aspects of the EO below, and online here is a separate discussion on how the Reshoring Manufacturing EO and other administration decisions may impact companies’ and investors’ next steps in considering reshoring efforts.

U.S. President Trump’s May 5 Executive Order aiming to promote American-made prescription drugs (“Reshoring Manufacturing EO”) directs the U.S. Food and Drug Administration (FDA) to review regulations, compliance policies, and guidance that pertain to the development of domestic pharmaceutical manufacturing, and take steps to do the following by November 1, 2025:

Eliminate duplicative or unnecessary requirements for streamlining and acceleration;
Maximize the timeliness and predictability of agency review;
Evaluate the current regulatory and risk-based prioritization framework for pre-approval inspections to “ensure all required inspections are prompt and efficient, and limited to what is necessary to ensure compliance with … Federal Law.;”
Expand early engagement programs that provide technical advice before facilities become operational; •Clarify guidance for manufacturing site changes, including for moving production from foreign to domestic facilities and validating new or updated manufacturing components; and
Improve enforcement of data reporting under 21 USC 360(j)(3), regarding the quantities of drugs commercially manufactured at each drug manufacturing site, including potentially publicizing the list of facilities, including foreign facilities that are not in compliance with such reporting requirements.

Increased barriers for foreign facilities

In addition, the Reshoring Manufacturing EO directs FDA to take the following steps by August 3, 2025, related to foreign drug manufacturing facilities:

Improve its risk-based foreign inspection framework to ensure more routine reviews of overseas facilities that supply the U.S., which shall be funded through increased fees on foreign manufacturing facilities, where consistent with applicable law. (We note that revisions to the relevant user fee legislation may be required to achieve this goals); and
Publicly disclose annual inspection data, categorized by country and manufacturer, to increase transparency and accountability.

The Reshoring Manufacturing EO further aims to reduce barriers through non-FDA angles, including streamlining Environmental Protection Agency (EPA) reviews and approvals for new or expanded manufacturing capacity, streamlining by the Army Corps of Engineers, and establishing a centralized coordination process managed by the White House’s Office of Management and Budget.

For our thoughts on how the Reshoring Manufacturing EO and other administration decisions may impact companies’ and investors’ next steps in considering reshoring efforts, see our analysis here.

Authored by David Horowitz, Mike Druckman, Sally Gu, Chris Middendorf, and Ashley Grey.