Top 10 Rules for Effectively Communicating with Regulators – Part 1

This month we spoke at the 2018 BIO International Convention in Boston, MA on How to Effectively Communicate with Regulators.  3D Communications has spent the last 15 years preparing companies for FDA pre-submission and advisory committee meetings.  During this time, we have developed our “Top 10 Rules” to help make the journey smoother and effectively hit your target.

In the next two blogs, we will discuss some of the common mistakes we see sponsors making in their communications with regulators – and some time-tested rules which apply across all types of regulatory meetings.

Common Mistakes

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. This can result in not having done the appropriate “homework” to understand the position of your reviewer or bias of your advisory committee member.
  • Having no clear agenda, messages, or “ask”. The FDA or CHMP is not your “regulatory consultant.”   They are not there to help advise your strategy or ultimate goal.  It is up to you to know your drug, your patient population, and your plan.
  • Ignoring/arguing with 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.

Rule #1 Build a Relationship With Your Reviewer And Your Division.

And great relationships take work.  The real goal should be to communicate and find a middle ground so that it doesn’t become antagonistic.  The question is HOW do you build that relationship?

First, you need to make sure you start the conversation early – don’t wait until an issue comes up or there is a crisis.  And a lot of people don’t realize this, but FDA has many opportunities to help you communicate with them.  It’s everything from picking up the phone to ask your reviewer a question, to “vendor days” and visits, to 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 10 things that are true – but if you hide the 11th, then the reviewer won’t trust you – possibly ever again.

Rule #2 Prepare Effectively.

Doing it right means it will likely take more time and work than you’re thinking.  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’s 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.

Rue #3 Analyze Your Audience and Environment.

Know as much as you can about the people in your meeting. In order to influence, we must know what influences our 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. FDA’s mission is to protect the 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 FDA, and more specifically 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 FDA to gain insights into what’s happening.  For example:

  • That FDA is focused on innovation and speed. In some divisions, that is pushing reviewers to get things done faster.  This may have very practical implications for companies as it may force sponsors to provide their regulator with data and analyses more quickly.
  • And 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 what you just said with their team.

In our next blog, we’ll discuss the next five rules to help your team best prepare content for your meeting.