The FDA has announced the establishment of a public docket to receive comments on issues related to accelerating the establishment of new pharmaceutical manufacturing facilities in the US. You can read the full docket announcement here. Not only is the Agency opening a docket for comment, but that same announcement included information on a public meeting titled “Onshoring Manufacturing of Drugs and Biological Products” to be held on September 30, 2025. The meeting will be a hybrid format offering both in person and virtual attendance. The meeting website that provides details on the logistics of the meeting and how to register may be found here.

The docket and meeting announcement reference the President’s Executive Order (EO) #14293 “Regulatory Relief to Promote Domestic Production of Critical Medicines” (the full text of the EO may be accessed here) as the basis for these new announcements. These announcements align with section 3, “Streamlining Review of Domestic Pharmaceutical Manufacturing by the Food and Drug Administration.” Parts of that section directed the FDA to review existing programs and to identify ways to provide clearer guidance on the requirements or recommendations for site changes that align with the objectives of this docket and meeting.

Along with the establishment of the docket and announcement on the meeting, additional reference is made here announcing the FDA PreCheck Program. The FDA PreCheck program “aims to support faster establishment of new U.S. pharmaceutical manufacturing capacity through earlier regulatory input, enhanced engagement, and efficient CMC assessments.” The program includes two phases:

    1. The Facility Readiness Phase – provides more frequent communication at critical stages of development and implementation phases before the site is operational.
    2. The Application Submission Phase –The FDA and applicants build on previous interactions in Phase 1 and engage through pre-submission meetings to resolve issues and expedite assessments of quality information.

 

Comments on the proposed program such as what elements of the proposed program are most likely to help the establishment of new facilities and if there are additional elements or implementation considerations in relation to the FDA PreCheck Program are also accepted to the docket and are topics for discussion and comment at the meeting. These are rare opportunities for pharmaceutical companies to participate in the shaping of new FDA policy, specifically to suggest the removal of regulatory obstacles as well as to suggest incentives to promote the establishment of new facilities within the US. As the President acknowledged in EO 14293, it can take 5-10 years in some cases to establish a new pharmaceutical manufacturing site and if the FDA is willing and eager to listen to ways to make that path easier and shorter, now is the time to speak up and ask for the guidance and the opportunities the pharmaceutical industry needs to make that process easier.

If you have questions or need assistance on navigating the current regulations and guidances to onshore pharmaceutical, biological, or medical device manufacturing or how to submit your onshoring change to the FDA, Lachman has experts who can help. Reach out to us today for a consultation at LCS@LachmanConsultants.com.