Seven Steps for Success at FDA Meetings

For pharmaceutical or device company teams, all FDA meetings have one common thread: the need to tell a clear story and to set the data or issue in context.

Just as the FDA has a process for determining whether a drug or device should be approved, companies need a proven process to keep their teams on track and prepare their presentations in the most efficient and effective way. Below are seven steps to help you get ready for FDA meetings.

1. Know your audience. There is no substitute for knowing and understanding the FDA personnel who will be attending the meeting. Conduct research to learn about their experiences, biases, and backgrounds in order to better anticipate their opinions. Determine who the decision-maker is – or who is likely to have the most influence at the meeting.

2. Understand the issues and the environment. Hand in hand with knowing your audience, it’s essential to understand the issues that are playing out in the environment. Do your homework. Review relevant precedents and actions by the FDA division responsible for evaluating the product. Be familiar with published or implied FDA guidance and consider how you can incorporate it into your strategy or presentation. Be aware of any issues relating to your therapeutic area or class of drugs. Based on your research, list the concerns and specific questions FDA attendees are likely to raise.

3. Set a specific goal for each FDA conversation or meeting. Determine what the objective is for the meeting. Are you trying to obtain FDA guidance? Present your development program? Obtain FDA agreement? Stay focused on the goal during each meeting. Seek specific answers and commitments from the FDA to achieve that goal. Strive for agreement on the main issues. Try to get clarity, direction, and if possible, commitment on these issues.

4. Be clear on your position and practice delivering it. Conduct a high-level messaging session before your meeting to ensure consistency across all communications. Keeping in mind the research you have done on the FDA attendees and the environment, brainstorm and identify potential issues among all stakeholders. Develop high-level messages to provide the basis for conversations with the FDA. Make sure your team clearly understands the target messages and is aligned with the company’s position. Determine who will deliver specific messages and who will answer expected questions. Then role-play a meeting in the same amount of time as your real meeting. That way you can see how long you have to deliver your messages – and what the likely pitfalls will be.

5. Make sure the FDA has pertinent materials for each meeting in advance so they can adequately analyze the information. Don’t data dump thousands of pages of background information. Instead, streamline the information and focus it on the issues and goals of each meeting. Include a proposed agenda, focused questions, and a background package or briefing document that includes the sponsor’s position, an outline of the product data, and your development recommendation.

6. Maximize your time at the meeting. Once you’re in the meeting, stay focused on managing your time carefully. Make sure there is enough time to deliver your key messages, ensure adequate discussion, and gain a clear understanding of answers and recommendations. Listen carefully to what the FDA team actually says. During in-person FDA meetings, pay attention to body language, internal dynamics, and offhand remarks. During phone meetings, listen to voice tone, and pay attention to anytime the FDA team may ask for a moment to go on mute. Stay focused on immediately correcting any misinterpretations or misconceptions they may have. Save the last five minutes of the meeting to summarize the discussion and obtain agreement on action steps.

7. Record feedback. Keep an ongoing list of all issues raised by officials during the FDA meetings and conference calls. Record how many times specific issues are raised to gauge their importance. Remember to note who at the agency is raising them. Again, specifically document times the FDA puts the meeting on mute – as this may indicate confusion or concern over a specific issue. Strive for clear agreement on critical decisions and make sure they are documented in the FDA meeting minutes.

Regardless of what happens at FDA meetings, it’s critical to keep lines of communication open with the agency. This is especially important if the FDA’s message is negative. Truly listening to what the FDA is saying is one of the most important elements of communication. Fostering a flexible, collaborative, and non-adversarial relationship with the FDA can go a long way toward surmounting difficult issues and achieving your goals.