3D Communications has spent the last 20 years preparing companies for FDA pre-submission and advisory committee meetings. During this time, we have developed our “Top 10 Rules” to help make your journey smoother and successfully hit your target.
This article will discuss some of the common mistakes we see sponsors make in their communications with regulators – and some time-tested rules that apply across all types of regulatory meetings.
The mistakes we’ve seen companies make usually fall into a few key buckets.
- Going into meetings without a clear understanding of your regulator or division. You must do the appropriate “homework” to understand the position of your reviewer or the bias of your advisory committee member.
- Having no clear agenda, message, or ask. The FDA or CHMP is not your regulatory consultant. They are not there to help advise you on your strategy or ultimate goal. It is up to you to know your drug, your patient population, and your plan.
- Ignoring/arguing with the FDA’s position or requests. The FDA usually tells you – or strongly hints – at what they want. Sponsors often have selective hearing or selective memory. We see this repeatedly when we come in and review the FDA correspondence.
- Going over the head of division contacts. Usually NOT a good idea! Regardless of the outcome, it can cause long-term damage with your review team.
To avoid these and other mistakes, follow our ten rules.
Rule #1: Build a Relationship with Your Reviewer and Your Division
Great relationships take work. The real goal should be to communicate and find a middle ground so that your relationship doesn’t become antagonistic. The question is HOW do you build that relationship?
First, make sure you start the conversation early – don’t wait until an issue comes up or there is a crisis. The FDA has many opportunities to help you communicate with them, from picking up the phone to ask your reviewer a question, to vendor days and visits or scheduling a formal meeting. Once you have the conversation or get the meeting, TELL THE TRUTH AND THE WHOLE TRUTH! Don’t withhold important information. You can tell your reviewer ten things that are true – but if you hide the eleventh, the reviewer won’t trust you – possibly ever again.
Rule #2: Prepare Effectively
Doing it right means your preparation will likely take more time and work than you think. But preparing effectively is a must. The last thing you want is to lose sight of what you’re trying to accomplish or lose control of the meeting. 3D Communications’ mantra is, “A meeting with a regulator is the wrong time for an original thought.” Be strategic and think through the short-term and long-term implications of what you say.
Rule #3: Analyze Your Audience and Environment
Know as much as you can about the people in your meeting. In order to influence, you must know what influences your audience.
In general, most regulators are science based. They look at the data and come up with their own conclusions. Therefore, your arguments need to be based in facts. However, the data don’t speak for themselves. (We’ll have more on that in our next blog.) Next, realize why they do what they do. The FDA’s mission is to protect public health, with a focus on getting safe and effective products to market. Most regulators are there for that same purpose.
If you want to understand your regulator, you need to understand the world in which they live. The regulatory environment is constantly changing and you need to stay on top of it to understand what may be influencing them, both on the scientific side regarding the standard of care and healthcare guidelines, and on the political side.
Rule #4: Talk to People Who Have Been There
One way to further your understanding of the environment at the FDA, and more specifically within your division, is to listen to people who have been there. We are constantly talking to people who have worked, or continue to work, at the FDA to gain insights into what’s happening. For example:
- The FDA is focused on innovation and speed. In some divisions, that is pushing reviewers to get things done faster. This may force sponsors to provide their regulator with data and analyses more quickly.
- Because reviewers don’t have time to sort through a morass of information, it’s more important than ever for companies to ensure that their submission documents are well organized and well written so reviewers can actually find what they are looking for.
Rule #5: Listen to Your Regulator
A revolutionary thought – and astounding how often it is ignored! Regulators usually tell sponsors want they want. Pay attention to their written responses. They remember them and will feed them back to you. If you’re in person, listen carefully to what they’re saying and to their voice tone as they’re saying it. Read their body language. If you’re on the phone, note if, and when, they put you on hold. It’s a signal that they are discussing with their team what you just said.
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. 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 the way people process information: start with your takeaway 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 the 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 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 nonverbal 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.