So the reaction to my first blog just among my friends and coworkers was pretty good, although rather limited…they liked my Regulatory Affairs and Wine connection and would like me to follow it up with Regulatory Affairs and Coffee and associated with that Regulatory Affairs and Chocolate…what can I say, we spend a lot of time thinking about what we put in our mouths! The subject of this blog, however, is more to do with what comes out of our mouths…or “How to Act at FDA Meetings” when somebody is actually listening and writing down what you say!

Over my 20+ years in RA, I have gone to many FDA meetings. In the past 6 years, they have been mostly preNDA or preIND meetings, but I have been lucky enough to be at a numer of End of Phas II (EOPII) and Advisory Committee meetings as well over the years. I have to say two things:

1. I learn something everytime I go
2. Companies prepare for these meetings in extremes

With regards to my first point, there is always something to be learned from FDA. Think of how many sponsors, projects and filings they see and you can benefit from their experience. To do so however, you need to listen! This is a pretty basic, “duh” point, but one not enough companies or regulatory folks pay attention to. The reasons for this are many, but primarily it is because as regulatory staff we are responsible for a) facilitating the meeting, including triaging responses from our own attendees; b) taking notes and making sure the FDA minutes are being recorded properly and last, but not least, c) leaving with positive outcomes. It is no wonder we sometimes miss the fine points of what the reviewers or division directors are saying. To this point, we can free up the more experienced attendees in the room if we take along other people to take notes and watch what the RPM is doing. Plus, what better way to learn and get FDA Meeting experience – that is how I acquired my knowledge. Just a thought…

As to my second point, about preparation, there needs to be two equally important types of prep…the prep of really good, focused, answerable questions and the prep for the meeting itself. Often, companies focus just on the meeting (showtime!) and don’t spend enough time thinking about what they really need to get agreement or guidance on and they do not structure the questions appropriately. Think about it this way, if it is a yes/no question (eg Does the agency concur?), what are the scenarios of not getting the desired affirmation. Will it change what you are able to provide or the direction you wish to go in. If it is not a yes/no question, be sure it is answerable and not open ended or you may end up either burning all your precious meeting time (1-11/2 hours tops) or going down a rat hole you cannot get out of…As for the meeting, you absolutely must prep, face-to-face at least twice, more if you have a rookie team or a gaggle of consultants, but there is such a thing as over-rehearsed. This isn’t a command performance, subject matter experts should be allowed to answer their counterparts and regulatory should be the facilitator for that…what ever you do don’t get talked into letting the CEO come and assume the regulatory role…that never ends well!!!