In our last blog we discussed five rules to help companies prepare for their interactions and meetings with FDA.  But preparation doesn’t stop once you analyze your audience.  In fact, it’s only after the analysis that the real work begins. In this blog, we’ll talk about the next five rules to develop your content.

Rule #6 Choose Your Team Wisely.

A very practical consideration is WHO you have attending the meeting to represent you and in what capacity.  Be specific.  Who will open the meeting from your side and moderate it?  Who will be the main presenter?  Will you bring an external Key Opinion Leader (KOL)? If so – make SURE you practice with them and know what they are going to say.  It only takes one remark by even a well-meaning physician to send you down the wrong path.  And the FDA will remember. Clearly define the role of each person in the meeting – and then practice as a cohesive team.

Rule #7 KISS Your Content.

Keep It Short and Simple.  This includes: your briefing materials for the meeting; your messages; if there is a formal presentation, then your script and slides; and answers to your questions.  Yes, you should write these out to make sure they are aligned and are crystal clear.    As Einstein said, “If you can’t explain it simply, you just don’t understand it well enough.”   Simplifying the information about your product or issue is YOUR job – not your regulator’s.

Structure your content in the way people process information: Start with your take-away headline, what you want the audience to remember, to focus and frame your data.  Then, prove your headline with facts and data.  And prioritize the facts. Only use the ones you absolutely need FDA to remember. Provide context on why the data matter, helping them visualize it with an example or a story.  And then bottom line your message by rephrasing the headline.

Rule #8 Control Q&A.

We understand that sponsors are often very worried about regulators’ questions. But the truth is, questions are a great way to establish your credibility and belief in your product and to deliver your key messages. So, don’t fear questions; prepare for them.

Based on the research you’ve done on the regulator and what you know about the issues surrounding your topic, identify the three questions you’re most likely to get and the three questions you most want to avoid.   Once you’ve identified them it’s time to figure out how to answer and bridge to your key message.

Rule #9 Be Human.

It’s not only the content that drives a message.  There is a lot of good research on the importance of the non-verbal message.  While there is no substitute for good data, remember that voice tone and body language either drive your message or block it.  So, say it like you mean it!   And if you don’t mean it, don’t say it!!!

As you’re talking to your audience, be “present.”  Pay attention to facial expressions, make sure people are “getting it.”   If they look bored, engage them.  Ask them a question.  Get them talking.   You always have time to regroup while they’re in the room.   So, when you’re in a hole – stop digging – and start fixing!

VERY importantly, identify areas where you agree. If you don’t agree on something that is important – speak up, adding data and examples of WHY you don’t agree – and do it respectfully.

Rule #10 Follow-Up

Our last rule is to make sure you follow up.

Since there are so many things happening during a meeting, don’t be embarrassed to take notes.   And summarize what you’ve heard, with the aim of getting agreement at the meeting. Also note if there are any follow-up items to share after the meeting. Feel free to submit minutes and don’t be afraid to reach out with questions.

Of course, there are more rules – but starting with these “Top 10” will get you off to a solid start at maximizing your regulatory communications.



Jamie (Waterhouse) Page, MBA uses insights gained as a lead reviewer and project manager at FDA to help clients prepare for FDA meetings. At FDA, Jamie was involved in a wide variety of meetings between FDA and industry including Q-Submissions, Pre-IDEs, Early Feasibility Studies, Expedited Access Programs, and Appeals meetings, and FDA advisory committee meetings. Connect with Jamie on Linkedin.

Cindy DiBiasi has built a reputation as a leading health care communications consultant by working with top executives at some of the world’s largest companies. Cindy helps clients identify their communications strategy and develop messages on controversial healthcare issues. Cindy’s work helps companies with regulatory approvals, commercial launches, and Value Communications for Market Access communications. Connect with Cindy on LinkedIn.