KEY POINTS
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FDA launches PreCheck program to cut approval timelines for new US pharmaceutical manufacturing facilities.
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Initiative follows executive order to reduce reliance on foreign drug production, particularly from China and India.
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The two-phase system will involve early design guidance and faster application reviews.
Program Aims to Speed Up Domestic Pharma Construction
The Food and Drug Administration (FDA) unveiled a new initiative to speed up and simplify the construction of pharmaceutical manufacturing plants in the United States.
The PreCheck program, announced August 7, 2025, will use a two-phase approval process to accelerate plant readiness and streamline application reviews, the FDA said in a statement.
The move could boost the construction of life sciences facilities and the demand for contractors, engineers, and suppliers who build them.
Drive for Pharmaceutical Manufacturing in the US
The program comes in response to a May executive order from President Trump directing the agency to cut red tape and reduce America’s dependence on overseas drug production.
FDA data revealed that more than half of pharmaceuticals sold in the U.S. are made abroad, with only 11% of active pharmaceutical ingredient (API) producers based domestically. Many are in China and India, a supply chain concentration that the White House has deemed a national security risk.
“Gradual overreliance on foreign drug manufacturing has created national security risks,” FDA Commissioner Dr. Marty Makary said in the announcement. “The FDA PreCheck initiative can help reverse this trend and ensure a resilient domestic drug supply.”
The administration estimates that it will take five to ten years to bring new US drug manufacturing capacity online, a timeline officials want to compress.
Two-Phase Objective: Speed Up Construction Approvals
For contractors, building product manufacturers, architects, and engineers, the FDA’s two-phase process directly affects design timelines, compliance planning, and the pace at which new pharmaceutical plant projects can break ground.
Phase 1: Facility Readiness Phase
Drugmakers will engage more frequently with FDA staff during key project milestones such as facility design, construction, and preconstruction. A Drug Master File will detail site layout and operations.
Phase 2: Application Submission Phase
Pre-application meetings and early feedback will help identify and resolve compliance issues sooner, particularly in the Chemistry, Manufacturing, and Controls (CMC) section of drug applications.
The FDA will present more details at a public meeting set for September 30, 2025, which will cover the program and other onshoring proposals.
Construction Industry Impact: What to Expect
For US contractors and trades specializing in pharmaceutical and biotech facilities, the initiative could open more opportunities for commercial construction projects. Faster approval timelines could mean shorter development cycles, earlier bidding opportunities, and an uptick in manufacturing facility construction.
Recent commitments to invest in US manufacturing have come from companies like Johnson & Johnson with $55 billion, $195 million from AbbVie, and $27 billion from Lilly, signaling a growing expected pipeline of U.S.-based manufacturing projects. However, potential tariffs on imported pharmaceuticals could shift project economics and influence where and when companies build.
Stay Connected
If implemented as planned, the FDA’s new PreCheck plan could bolster US drug security and fuel demand for construction expertise in high-specification, regulated environments. Stay up-to-date, as the program is still under development, and key requirements may change.
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