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At a time when more than 50% of pharmaceuticals distributed in the United States are produced overseas, the FDA has introduced PreCheck, a new program intended to fortify the domestic pharma supply chain by boosting regulatory reliance and encouraging the development of US manufacturing facilities.¹

FDA PreCheck was created after the passing of Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which instructs the agency to simplify the review of domestic pharma production, remove unnecessary regulatory burdens, and enhance the timeliness and predictability of reviews. It consists of a novel two-phase process that supports the launch of new drug manufacturing facilities in the US.

The US mainly depends on foreign sources for its active pharmaceutical ingredients (APIs). Overall, only 11 of manufacturers that produce these APIs are based in the United States.

“Our gradual overreliance on foreign drug manufacturing has created national security risks,” commented Marty Makary, MD, MPH, commissioner of the FDA. “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”

Two-phase process designed to streamline approvals

The process starts with the Facility Readiness Phase, which offers pharma manufacturers consist communication from the FDA, especially at the vital stages in development, such as facility design, construction, and pre-production.

Although it hasn’t been specified as to whether it’s required, this aforementioned step also advises companies to share their facility-specific info via a Type V Drug Master File (DMF). Sample information includes layout of site ops along with a description, Pharmaceutical Quality System features, and Quality Management Maturity practices. A key detail the FDA notes is that this DMF—specific to each unique facility—can be referenced in a drug application as appropriate.

The second portion of the process is the Application Submission Phase, which revolves around accelerating the expansion of the application’s “Chemistry, Manufacturing, and Controls” section by holding pre-application meetings and feedback early on in the process.

Tariffs and trade tensions accelerate reshoring efforts

PreCheck marks the latest initiative from the United States to encourage local manufacturing, with tariffs being the initial step.

Trade wars featuring the United States versus all other nations have been in full swing for about six months now, and regarding pharma, Trump stated that these levies on pharmaceutical imports could ultimately reach up to 250%, marking a new high.² Yesterday morning, the Trump administration enacted tariff rates between 10% to 50% on a multitude of trading partners,² and additional duties could potentially be forthcoming within the next week.³

Manufacturers are doing their best to prepare for what could be to come. Companies like Regeneron, Roche, Merck, and Thermo Fisher have already been working to reshore manufacturing to the United States in an effort to sidestep steep tariffs. This includes a combined $53 billion by Regeneron and Roche to improve their manufacturing and R&D infrastructure, $1 billion by Merck, and $2 billion by Thermo Fisher.²

Piramal Pharma Limited also shared it would be investing $90 million toward growing two of the company’s plants located in the United States: Lexington, KY, and Riverview, MI. Further, AstraZeneca reported that it plans to invest $50 billion by 2030 in US-based drug manufacturing and R&D, marking its largest single manufacturing investment globally. The announcement is headlined by a new state-of-the-art facility in Virginia that will produce active pharmaceutical ingredients (APIs) for weight management and metabolic treatments, leveraging AI, automation, and data analytics.

FDA to host public meeting on onshoring manufacturing

On Sept. 30, the FDA will be holding a public meeting titled “Onshoring Manufacturing of Drugs and Biological Products” from 9 a.m. to 4 p.m, which will feature a presentation of the draft FDA PreCheck framework, stakeholder discussions on its strengths and opportunities, and consideration of additional factors to address current onshoring challenges within the agency’s authority.

References

1. FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing. FDA. August 7, 2025. Accessed August 8, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing?utm_medium=email&utm_source=govdelivery

2. Saraceno N. Trump: Tariffs Could Potentially Hit 250%. Pharmaceutical Commerce. August 7, 2025. Accessed August 8, 2025. https://www.pharmaceuticalcommerce.com/view/trump-tariffs-could-potentially-hit-250

3. Eaton ES. FDA Rolls Out New Programme to Speed Up Drug Manufacturing at US Sites. FirstWord Pharma. August 7, 2025. Accessed August 8, 2025. https://firstwordpharma.com/story/5987373