FDA seeks feedback on ways to bring manufacturing back to the US
The US Food and Drug Administration (FDA) is seeking public input on its PreCheck program, which aims to establish new pharmaceutical manufacturing facilities in the US to enhance the pharmaceutical supply chain.The PreCheck plan, announced on 7 August, aims to accelerate the development of high-priority pharmaceutical manufacturing facilities in the US and enhance the domestic pharmaceutical supply chain (RELATED: This Week at FDA: PreCheck manufacturing program, new FDA chief counsel, and more, Regulatory Focus 8 August 2025).
The notice requesting feedback said that pharmaceutical manufacturing was “largely a domestic enterprise " up until the 2000s; however, in recent decades, manufacturing has increasingly moved overseas.
The notice states that, “today more than half of the pharmaceuticals distributed in the US are manufactured overseas.” As of June 2025, around 53% of brand-name drug products and 69% of generic drug products have at least one manufacturer located outside of the US. Further, 9% of active pharmaceutical ingredient (API) Type II Drug Master File (DMF) holders are based in the US, while 22% are based in China and 44% in India.
FDA is requesting public comment on several questions, including:
- What are the main regulatory obstacles in establishing a new domestic pharmaceutical manufacturing facility?
- Are there any elements in the PreCheck program that will help US pharmaceutical manufacturers launch new facilities in the US?
- Are there any implementation obstacles with PreCheck?
- Is your company willing to provide information about manufacturing facilities subject to FDA oversight? Do you have any concerns about sharing this information?
According to the notice, the PreCheck program aligns with President Trump’s executive order 14293 issued in May to boost domestic production of pharmaceutical products; this order also urged the FDA to increase inspections of foreign drug manufacturers and to reevaluate its approach to pre-approval inspections (RELATED: FDA to expand unannounced foreign inspections after Trump executive order, Regulatory Focus, 6 May 2025).
As proposed, PreCheck consists of two phases: facility readiness and application submissions
FDA also announced a public meeting on 30 September to discuss pharmaceutical manufacturing onshoring. During this meeting, the agency will present a draft framework to facilitate the onshorin. Participants will then engage in a guided discussion about the proposed framework, examining its strengths, weaknesses, and potential opportunities.
FDA is accepting comments on program until 30 October. The docket number is FDA-2025-N-2489.
Notice
