Post-Warning Letter Interaction with FDA

Q: We received a warning letter (WL) from FDA, to which we provided a written response. Although we are confident that our reply is comprehensive, we would like to get confirmation from FDA. Is there a way to ask FDA to give us this feedback?

A: It is understandable that you want to be certain that your response to FDA is complete and acceptable. You should stay in contact with the person(s) mentioned in your WL and to who you addressed your response letter. In addition, under the Generic Drug User Fee Amendments (GDUFA or GDUFA III Commitment Letter) (1), your facility may be eligible for a Post-Warning Letter Meeting, as described in section VII(D)(1) of the GDUFA III commitment letter (2).

You can only be granted such a meeting if you have “submitted to FDA a thorough and complete corrective action and preventive action (CAPA) plan that addresses all items cited in the warning letter, and reasonable progress has been made toward remediation” (2). As mentioned above, your facility needs to keep FDA informed regularly about progress with the remediation effort as detailed in the CAPA plan. As FDA must see what progress you made, they cannot grant a meeting earlier than six months from the date of a company’s initial response to a WL. In fact, you should be certain that you have reached significant milestones in your remediation program before applying for a Post-Warning Letter Meeting, or FDA may deny you such a meeting.

What can you expect from such a meeting with FDA? The meeting will allow you to present the remediation progress to date and the projected completion dates for any remaining CAPA activities. FDA will voice any concerns they may have regarding your roadmap back into compliance. The agency will tell you if you are on the right track or if additional efforts are needed. It will give you assurance that your planning schedule is appropriate. It should be noted that FDA’s advice is not binding. Furthermore, agreeing to a Post-Warning Letter Meeting “does not preclude FDA from taking any regulatory actions necessary, including a follow-up inspection at any time” (2). You can request a maximum of two Post-Warning Letter Meetings.

Success depends very much on good preparation. You should, therefore, study the FDA’s draft guidance (3) that provides information on how to prepare the Meeting Package and the Meeting Package Content. Should you be eligible for such a meeting, it is recommended that you include this in your overall communication plan with FDA. Returning to a compliant state of operations at your facility has highest priority. Leveraging all available tools to inform and convince the agency of your sincere intentions, actual progress, and estimated fulfillment dates of all commitments is a sensible and logical approach.

References

1. FDA. Post-Warning Letter Meetings Under GDUFA. September 2023, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/post-warning-letter-meetings-under-gdufa
2. FDA. GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027. https://www.fda.gov/media/153631/download
3. FDA. Post-Warning Letter Meetings Under GDUFA Guidance for Industry. September 2023, Generic Drugs, https://www.fda.gov/media/171785/download

About the author

Siegfried Schmitt is vice president, Technical at Parexel.