FDA Post-Warning Letter Meetings are Not Agency Consultations

After receiving an FDA warning letter, eligible generic drug firms now have the option of scheduling a meeting with FDA to discuss remediation efforts resulting from the deficiencies cited in the letter, as described in a recently released draft guidance.

At the PDA-FDA Joint Regulatory Conference on September 20, 2023, in Washington, DC, FDA Center for Drug Evaluation and Research (CDER) Office of Manufacturing Quality (OMQ) Office of Compliance director Francis Godwin was asked during the Q&A after his presentation on current GMP compliance trends and topics for specifics regarding the post-warning letter meetings.

A multi-part question submitted by an attendee asked:

• How many post-warning letter meetings have you done under the new GDUFA commitment?
• What are your initial impressions of their usefulness?
• Are there any items from the recent guidance you would like to emphasize based on what you have seen from the early requests you have received?

In his response, Godwin pointed to the Post-Warning Letter Meetings Under GDUFA FDA Guidance issued earlier that month.

According to the Federal Register notice announcing the availability of the draft guidance, it “provides information on the implementation of the Post-Warning Letter Meeting process for certain drug manufacturing facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments (GDUFA).”

According to Godwin, “We issued the guidance a few weeks ago, so definitely take a look at that. The post-warning letter paradigm has been in place since October 2022. There were goal dates around it because we had to ramp up to build the architecture.” He noted that so far, the agency has only had a few of those meetings.

“In the majority of requests where a firm wanted to meet with us,” the agency responded back to the requester, “We think your [warning letter] response is in good shape. We are going to ask our colleagues in ORA (Office of Regulatory Affairs) to go out and inspect you and verify your corrective actions.”

Godwin told the conference attendees that the post-warning letter meetings FDA has conducted “were good in that the firms had corrected the majority of things and the meeting was to clarify the last few things.” ”I want to be very clear,” he emphasized, “A post-warning letter meeting is not an FDA consultation. If you come into a meeting and say, ‘Tell us what we need to do to fix this,’ we will deny the meeting and say, ‘You haven’t done your homework.’ It is the firm’s responsibility.”

Godwin explained that post-warning letter meetings are for a company “that has done 90% of its CAPAs (corrective and preventive actions) and is in good shape but has one or two things that are outstanding.” The firm can talk with FDA about how to “figure out the issues and the holdups, and how we bridge the gap. It is to get you over the finish line and get you to inspection.”

In one of the meetings, “We met with a lab, which was very good because there were some method-specific things, and we were able to connect the FDA chemist who knows more about that test method than anyone, I think, on the face of the Earth, and the laboratory to talk about the nuances. In that case, it definitely helped.”

“We are still learning. We have the draft guidance. Even the GDUFA commitment letter talks about how we will revise this program as we go through it because we are going to be learning. If you have questions or comments, please submit them to the guidance. We will be taking that feedback as we go,” Godwin concluded.

Comments close on the draft guidance on October 5, 2023. The Docket No. is FDA-2023-D-3370.