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Thoughts on FDA AdComms

Generally I don't like vague posts, but this one needs to be a little vague on purpose.

This may be the lawyer in me, but when you are asked a question at and FDA Advisory Committee and you answer it, answer the question asked, and then stop. It is that second part I want to focus on a little.

People have a tendency to either answer the question with considerably more information than is needed, or to answer the question and then when no reaction from the panel to keep going and ramble on with the previous reply. Both of these reactions are issues, and both need to be addressed. The first of these is likely the easiest to fix. Clean up your script in advance and stick to your script. It is very important to script out responses to possible questions. Even if the question you eventually get is slightly different than the one you practiced for, it is still important to have the concept scripted so that you don't give them information overload or come off as condescending. While you are there to educate the Agency and Committee members, they are very educated people and experts in their fields. You don't want them to think that you feel they need an education.

The second part of this is that once you have answered the question, stop. If you must speak about a connected topic, give a short bridging statement and then discuss briefly the connected topic. If you have finished answering, however, and you get no vocal reaction from them during the Q&A portion, do not just begin going on to fill the silence. You have answered the question. Let them process it. Likely one of them will ask a question after a short pause. This is an old lawyers trick to trap people. Generally we want to be helpful, so if you are silent, people will try to fill that silence with information they think you want to hear. If you have answered the question and don't have a connected topic, just stop.

What is a connected topic? It depends. If you are discussing Safety data and you just discussed cardiac events, and have a particular example that ties in, then perhaps bridge the two with a comment such as, "while our cardiac data has a difficult risk/benefit profile, if you look at the most serious events our data show..." Of course this is only a useful bridge if the data is positive.

If you are going into an FDA Advisory Committee you should not go alone. Using internal resources only tends to give you tunnel vision. External consultants can give you a fresh view and perhaps an approach you hadn't thought of. Using a mock panel made up of KOL's is also a key to success. Which ever way you go, the best advice LRCG can give is prepare and rehearse, rehearse, and rehearse.

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