The United States Food and Drug Administration has launched its new FDA PreCheck.
The FDA says that the new programme is designed to give domestic pharmaceutical manufacturing in the US a leg up by “increasing regulatory predictability and facilitating the construction of manufacturing sites”.
The administration will hold a public meeting on 30th September that will, among other things, feature a presentation on the draft framework being planned for this. This presentation will explore the programme’s strengths and opportunities, but will also explore what other avenues can be taken to promote onshoring.
The FDA Commissioner, Marty Makary, said that the initiative is one of many steps to reverse over-reliance on foreign drug manufacturing that has created national security risks.
“Our gradual over-reliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary, MD, MPH. “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.”
The “over-reliance on foreign drug manufacturing” concept is a nuanced situation that was highlighted very publicly during the pandemic. With major companies like Pfizer having huge operations in the US, it can be hard to understand why there were such huge issues when international supply chains were disrupted.
The PreCheck programme introduces a two-phase approach
It all comes down to sourcing the different parts of a puzzle. Though the US does dominate high-value, patented pharmaceutical production due to advanced R&D capabilities and strict quality controls, India and China are major hubs for generic drug manufacturing and active pharmaceutical ingredient (API) production, benefiting from lower costs and large-scale facilities.
Many daily medications used by the public are unbranded “generics”, and products that require an ingredient sourced from abroad. In fact, the FDA recently stated that of the manufacturers that produce APIs used in FDA-approved products, only 11% are US-based.
In 2025, the US government created an executive order that catalysed the creation of the new FDA PreCheck. Executive Order 14293 is titled "Regulatory Relief to Promote Domestic Production of Critical Medicines," and directs the FDA to streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements while maximising review timeliness and predictability.
A two-phase approach to facility approval
The PreCheck programme introduces a two-phase approach to facilitate new manufacturing facilities in the US.
First, the
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