FDA to encourage new manufacturing sites with its PreCheck programme

The US Food and Drug Administration (FDA) has unveiled plans to encourage the construction of new pharmaceutical manufacturing facilities as part of its push to strengthen the country’s domestic supply chain.

The move comes as pharma tariffs returned to the agenda, with a 15 percent rate on pharma product imports agreed with the EU last week and President Donald Trump suggesting industry tariffs could eventually surge to 250 percent.

Alongside that stick the FDA’s new PreCheck programme offers the carrot of assistance with a two-pronged approach that would see more frequent communication between the regulator and pharma companies during site construction and then a streamlined application process.

Active pharmaceutical ingredients (APIs) are a particular concern to the FDA, which notes that only 11 percent of the APIs used in pharma products on the US market are made by US manufacturers.

But the globalised nature of the pharma supply chain is also a broader issue for the US administration, with the FDA noting that “more than half of pharmaceuticals distributed in the US are manufactured overseas”.

FDA Commissioner Marty Makary said: “Our gradual over-reliance on foreign drug manufacturing has created national security risks. 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.”

FDA PreCheck was created in response to President Trump’s executive order to review domestic pharma manufacturing and then “eliminate unnecessary regulatory requirements while maximising review timeliness and predictability”.

As part of the scheme’s encouragement to onshore manufacturing the FDA will offer more frequent communication during facility design, construction and pre-production as part of its Facility Readiness Phase.

That phase also encourages firms to provide the regulator with comprehensive facility-specific information through a Type V Drug Master File (DMF). This would include elements such as site operations layout and description, pharmaceutical quality system elements and quality management maturity practices.

This facility-specific DMF can then be incorporated, by reference, into any appropriate drug applications involving the site.

Next, an Application Submission Phase focuses on streamlining the development of the Chemistry, Manufacturing and Controls section of the site’s application through pre-application meetings and early feedback.

While the new programme aims to ease the construction of new sites, the threats posed by import tariffs have already been followed by a number of manufacturers, including AstraZeneca, Lilly, Johnson & Johnson, Roche and UCB, making billion-dollar investment pledges.

The next stage for FDA PreCheck will see its draft framework discussed at the Onshoring Manufacturing of Drugs and Biological Products public meeting, which will be held on 30 September 2025 at the FDA White Oak Campus in Silver Spring, Maryland and online.