Any meeting with the FDA is critically important to Sponsors. We all know that a tremendous amount of time and effort goes into planning for these meetings. But even before this step the decision to ask for a meeting and the contents of the meeting package should be carefully considered.
Typically, a meeting is requested to gain insight and direction about the development plans that a Sponsor has defined. On its face this sounds easy. This all depends on how clear a Sponsor is about the current status of the program and what tasks are defined in the path ahead. In addition, keep in mind the new guidance from the FDA “Formal Meetings Between the FDA and Sponsors or Applicants“.
A meeting request with the list of questions can be submitted to the Agency ahead of a meeting package. The sooner the meeting package is provided to the Agency the better. You may decide prior to the meeting to change the questions, if it occurs before the meeting package is forwarded this is no problem. The questions can deviate from the initial meeting request information and the meeting package should provide the background for the new questions.
However if you decide to change the questions after the meeting package has been submitted, then a discussion should occur with the project manager. If there change can still be supported by the meeting package submitted this would be a minor change. If the change requires additional background material this must be discussed based on the amount of information and the time remaining before the meeting.
It can happen that additional questions come to mind during the meeting and a new direction should be probed. There are limits to how far from the meeting package you can deviate. The purpose of the package is to provide specific background to allow the agency to see many sides of the question being addressed and make an informed commentary on the question being asked. Obvious extensions of the existing list of questions could be allowed but the request should be stated as outside the planned discussions for the meeting minutes.
Even when the Agency provides an answer to specific questions, references to the guidance documents and language that these will be review issues may always be inserted into the meeting minutes to protect the Agency.
When can you actually get an answer to your question? When you have provided various sides to the arguments, thought through all possible outcomes and provided the Agency with a safe and reasonable path, then there is the possibility that you will get concurrence. You must pose the question such that the Agency understands what you are basing the question on and provide the path for the Agency to come to an agreement. The more advanced the program the potential exists to obtain specific answers from the Agency.
If the information provided in the package is vague, the answer will most likely be: this is a review issue. When the questions posed to the Agency are open ended or call for decisions on uncharted territory, it will be difficult to get a specific answer.
The following are Camargo’s Guidelines for Discussion with FDA:
- The FDA Project Manager runs the meeting from the FDA side and the Sponsor should have one primary person defined ahead of the meeting.
- Be on time or early.
- Review all the questions that have been submitted to the FDA and prepare the answers.
- The Sponsor’s primary will assess the topic (or review the agenda if available) and will ask individuals to address the answer to questions when appropriate.
- Do not address any business or financial impacts. Do not even mention this.
- Do not argue.
- Be open and honest in answering questions or discussing points that the FDA is interested in.
- Do not hold information back.
- Do ask for clarification or ask to understand the FDA’s viewpoint when you are unclear on a discussion point, (typically the Sponsor’s primary will do this, but others can be asked by the primary to answer a question, then it is appropriate for that person to speak).
- The Sponsor should assign a note taker and will provide unofficial notes. To be clear, the FDA meeting minutes are the only official record.
- If the FDA asks a question that we need discussion internally on before answering, we will ask to get back to them on the following Monday.
- The Sponsor is the final decision maker for the program. No decisions have to be made during an FDA meeting and it is appropriate to define a timeframe for responding to specific requests.