Q. How can my company participate productively in a regulatory meeting with FDA?
A. An invitation to a regulatory meeting with FDA might not be preferred, but it isn't entirely negative. FDA management initiates a regulatory meeting to inform responsible individuals about how one or more products, practices, processes, or other activities are considered to be in violation of the law (1). FDA views regulatory meetings as another tool to achieve prompt, voluntary compliance, typically initiated either to advise and educate prior to a warning letter or to provide additional assistance or direction after a warning letter. In the former example, FDA may use the regulatory meeting tool to deal with small firms, new firms, firms with a good history of compliance, or firms who make lower-risk products. In the latter example, FDA may use the regulatory meeting after a follow-up re-inspection found progress but lack of full compliance—the meeting would be another attempt to achieve or accelerate compliance before determining that it is necessary to initiate an enforcement action (e.g., injunction, seizure).
There are some steps that should be taken to maximize one's chances of a productive and successful regulatory meeting.
- Know the issues at hand and FDA's concerns.
- Prepare a slide deck that outlines corrective actions planned and accomplished. Include sufficient substance on the corrections, including metrics, timelines, and accountability.
- Be sure to address systemic corrective actions, and not merely spot fixes, to potentially larger problems that could span multiple product lines or even multiple manufacturing locations.
- Think of the specific areas of concern and the potential questions that could be asked. Address them proactively in the presentation or be prepared to address them fully during discussions.
- Inform FDA who will be in attendance and request a list of likely FDA participants. The list of company participants should be limited but clearly must include executive management and other managers with knowledge, responsibility, and accountability for the issues at hand.
- The highest-ranking company official is generally in charge of the company's actions at the meeting, opens the presentation, and directs questions to other company officials with the expertise needed to answer them.
- All company officials in attendance must be fully knowledgeable of the issues and the company's corrective action plan to present information or answer questions during the meeting.
- When answering questions, listen carefully and be certain you understand the question to ensure your answer is responsive.
- If a question cannot be answered by any company official present, then promise to respond as soon as possible after the meeting with the required information.
- At no point of the meeting should the company seek to make excuses or defend past actions or decisions. The meeting is about moving forward with complete, systemic corrective actions to achieve and sustain compliance.
- Each company official must be 100% truthful always, without exception, caveat, or nuance.
- Any open questions from the meeting should be addressed promptly, and periodic updates should continue as decided during the meeting.
- The company's meeting minutes should be shared with FDA to ensure full and mutual understanding of all concerns and commitments.
- Executive management must ensure that all commitments made in the meeting are completed on the timetable promised and that the company achieves and sustains substantial compliance with all laws and regulations.
- Upon FDA's re-inspection, it must be clear that systemic corrective actions have been completed, that they are effective, that all commitments have been supported, and that the company is operating in substantial compliance with the law and regulations. Failure to live up to commitments after a regulatory meeting is a recipe for enforcement action.
A company's measure for success for a regulatory meeting should actually be quite consistent with FDA's measure for success: a clear commitment to address all concerns and to achieve and sustain compliance with the law and regulations.
1. FDA, Regulatory Procedures Manual, Section 10-3, 2011,
http://www.fda.gov/ICECI/compliancemanuals/regulatoryproceduresmanual/default.htm#_top, accessed June 17, 2013.