FDA PreCheck Initiative Draws Strong Industry Reaction at Recent Stakeholder Meeting

As questions continue to swirl around FDA’s new PreCheck Initiative, the agency held a detailed listening session with industry leaders. ​​To help our readers cut through the noise, we reviewed the agency’s September 30 meeting and distilled the key insights, reactions, and concerns so you don’t have to sift through the full transcript.

In August, FDA announced FDA PreCheck – “a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States.”

The initiative includes two complementary phases: Facility Readiness and Application Submission, intended to streamline communication and reduce uncertainty for manufacturers.

The Facility Readiness Phase provides manufacturers with more frequent FDA communication at critical development stages, including facility design, construction, and pre-production, with a suggestion from FDA that companies provide comprehensive facility-specific information through a Type V Drug Master File (DMF).

The Application Submission Phase centers on streamlining development of the Chemistry, Manufacturing, and Controls (CMC) section of the application through pre-application meetings and early feedback designed to build awareness of facility and manufacturing strategies for the application.

During the September 30 meeting at FDA headquarters in Silver Springs, Maryland, the agency provided important clarifications on the program’s scope and limitations before turning to industry feedback. The goal of the meeting was to gather comments on the program, which FDA emphasized is voluntary. Agency officials moderated the session, which centered on four questions for industry, and encouraged the 24 in-person attendees to share their perspectives. The session was also streamed live.

Stakeholder Discussion Focuses on Four Critical Issues

Michael Kopcha, Director of the FDA Office of Pharmaceutical Quality (OPQ), emphasized two key points in his opening remarks that included key clarifying comments on each of the program’s phases:

• After a manufacturing facility has completed the inspection readiness phase, an inspection of the facility may not be necessary
• The only part of the application process that will be expedited is the Chemistry, Manufacturing, and Control (CMC) portion; clinical and other parts of the application will follow the usual timeline

The rest of the meeting was gathering industry input on four questions. The questions are listed below, along with a sampling of the industry input.

1. What do you consider the most significant regulatory hurdle in establishing a new domestic pharmaceutical manufacturing facility?

• The difficulty of making post-approval changes and the inspection requirements around those, also around site transfers, including the uncertainty and inflexibility of the FDA processes
• Uncertainty arising from issues with coordination between the various FDA centers regarding Preapproval Inspections (PAIs), Pre-Licensing Inspections (PLIs), and pre-inspection submissions
• Good Manufacturing Practices (GMP) is only evaluated in the context of a product; suggested the creation of a GMP certificate for approval of facilities, like in Europe
• API manufacturers want clarity around who will interact with FDA in the case of Contract Manufacturing Organizations (CMOs)
• Small companies may not have enough staff to supply information
• Need to establish a predictable timeline for interaction during construction and startup phases
• Need to better understand how this applies to seasonal products with short manufacturing windows (e.g., vaccines)

2. Which specific element(s) of the FDA PreCheck proposal are most likely to help the establishment of new US manufacturing facilities?

• Early engagement and having the FDA available for consultation
• General collaboration/partnership between FDA and industry
• Any incentives offered
• The facility readiness phase, if implemented properly, can help de-risk a sponsor’s view of the inspection process

3. Are there additional elements or implementation considerations that should be considered in the FDA Pre-Check proposal?

• Extend the program to include expansion of existing facilities and the addition of advanced technologies, including product transfers, product launches, and new BLAs and NDAs in existing facilities
• It would be helpful if multiple sites under the same Quality Management System (QMS) could all be treated as the same, in part to help with post-approval changes
• Include a risk-based approach depending on individual company experience with product types and technologies
• Prioritize domestic inspections
• Expand program to CMOs
• Decouple GMP and PAI inspections like the EU does
• Document discussions and decisions so they will not be questioned later as different eyes review over time; non-binding discussions are not helpful.
• In the generic space, 90% prescriptions are 12% of the spend; 5-7 years to build a new plant, 3-5 years for a new line; need to have economic incentives to bring manufacturing back to the U.S.
• Need the ability to leverage previous submissions
• Consider how it will be supported without impacting other FDA programs.
• Formal sharing of results with local agents who will be conducting routine inspections to inform those inspections
• Extend the program to key intermediate suppliers
• Keep the same reviewers in place as the process progresses

4. Would your company be willing to provide information about manufacturing facilities relevant to FDA oversight (e.g., facility design, quality systems, CGMP compliance, processes and controls, qualification or validation data) in advance of, or separate from, an application submission? What concerns might you have about sharing this information?

• Yes, but need to understand better what information is going to be requested and to be sure IP is protected
• Suggest feedback from FDA as the program progresses on what is too much or too little information
• Need to ensure that confidentiality is maintained with CDMO partners
• Need clarification on the scope of information required that is not normally required as part of a drug application submission
• Need to better understand the proprietary nature of interactions during construction when issues can arise, and whether it will be documented and available through FOI
• Submitting Quality Management Maturity (QMM) information is “risky” considering that QMM programs are not fully developed
• QMS information is difficult to package, usually viewed on inspection
• Suggest sharing site master files from EMA for facility information, keeping in mind they are updated for each inspection
• Agree that a Type V DMF is a good place to share the requested information

At the end of the session, Grace Graham, Deputy Commissioner for Policy, Legislation, and International Affairs, made the following comments:

“Decoupling, streamlining, and more up-front communication is helpful and would be useful… We will have to think about how to go about managing and broadening the scope and who could qualify for a program like this and how. We need to balance all the goals with the ongoing work including meeting user fee deadlines and getting all the work we need to do done.”

Conclusion

The FDA PreCheck Initiative was broadly welcomed as a strategic step toward strengthening U.S. manufacturing competitiveness. However, industry feedback underscored the need for:

• Greater clarity, predictability, and confidentiality protections,
• Expanding the program to include CMOs
• Alignment across FDA centers, and
• Economic and procedural incentives to make onshoring sustainable.

If implemented effectively, FDA PreCheck could modernize regulatory engagement and accelerate domestic facility readiness, reinforcing national supply chain resilience.