The GDUFA III commitment letter (here) outlined a number of industry-requested improvements to the GDUFA program. One such request related to the age-old problem of timely resolution of compliance problems resulting in a warning letter at a facility and the clearance of that warning letter. Specifically, in section VII(D) of the commitment letter, the “FDA agreed to establish a post-warning letter meeting process for facilities to obtain preliminary feedback from FDA on the adequacy and completeness of corrective action and preventive action (CAPA) plans, to resolve the inspectional deficiencies identified in the warning letter.” Thus arose the “Post-Warning Letter Meeting, as described in section VII(D)(1) of the GDUFA III commitment letter,” which is described as “a meeting with FDA regarding the facility’s remediation of deficiencies identified in a warning letter.” The guidance document can be found in full here.

The requirements for eligibility for a Post-Warning Letter meeting include:

  • The facility’s Current Good Manufacturing Practice (CGMP) compliance status is “Official Action Indicated” (OAI) as a result of an FDA inspection;
  • The facility has paid a GDUFA facility fee as described in section 744B(a)(4) of the FD&C Act for the current fiscal year or is named in a pending ANDA application; and
  • The regulatory action (e.g., warning letter) is limited only to violations and/or deviations from section 501 of the FD&C Act (21 U.S.C 351) related to human drug manufacturing, including the manufacturing of a drug-device combination product.

It is important to note that the “FDA intends to accept meeting requests from the facility, parent company, or authorized legal representative. The FDA does not intend to accept meeting requests from third parties, such as applicants (unless the applicant and the facility are the same legal entity) or customers of the facility.”

The guidance outlines the GDUFA III performance goals for granting, denying, or deferring in favor of reinspection as follows:

  • In FY 2024, fifty percent of eligible requests within thirty days of request.
  • In FY 2025, seventy percent of eligible requests within thirty days of request.
  • In FY 2026 and FY 2027, eighty percent of eligible requests within thirty days of request.

It also describes what must be included in meeting requests, the contents of meeting packages, and how the Agency assesses meeting requests. The guidance discusses communication with the requestor if a meeting request is granted, denied, or deferred (if “after review of the meeting request the FDA has determined that a re-inspection is the most appropriate next step” (i.e., deferring the meeting in favor of re-inspection)).

The guidance also discusses cancelation and rescheduling of meetings as well as procedures for the conduct of meetings. Quite interestingly, the guidance notes that “the facility may generate their own meeting minutes for their internal use. The FDA does not intend to accept or comment on firm-generated meeting minutes and does not intend to consider them an official reflection of meeting discussions. Any FDA meeting notes of the meeting are considered internal Agency documents. The FDA does not intend to permit recording of these meetings without prior written FDA consent.”

It will be interesting to see just how many meetings are submitted to the FDA and how many of these are granted or denied as well as to see, ultimately, whether these meetings are helpful in lessening the time to clear warning letters. We hope that the process and effort provide a clear benefit to both the FDA and industry.