Building a Case – AdComm Preparation, Part 1

Today I am giving a talk here in Washington about preparation for advisory committees. Over the years, I have had occasion to attend more meetings of FDA Advisory Committees than I care to think about, often with the purpose of helping a company on their own approach to an FDA Advisory Committee meeting – sometimes on product approval, sometimes regarding a policy issue.  I thought it might be worthwhile to cover a little bit of what I will be talking about today.

First of all, of course my remarks are aimed at the non-clinical aspects of AdComm preparation.  To prepare for this task, I began assembling a data base – no surprise to those who know me.  I went back to 2009 and profiled every Advisory Committee meeting regarding a drug, tracking the committee, the date, whether it was held jointly with another committee, whether it was a meeting to consider an approval or whether it was a meeting regarding an issue of policy, the company, the compound, the indication and whether or not there was a definitive positive vote.  As of now, the data is pretty raw, meaning I haven’t had the chance to go through and ensure that all of the entries are correct.  Nor did I look at every angle the way I would like to – for instance, what is the track record of individual companies – so the numbers I will have today will not be final. But I did find that of the over 200 meetings held since 2009, roughly just over half of those that considered approvals had positive votes (again without the benefit of the yet to come review of the entries).

When I broke it down by committee, one can see that some committees, like Oncology and Endocrinology, have been very busy – but the positive vote rate varied considerably between the two.  Without going into the specifics of the numbers (until I have had a chance to check the entries), it does indicate that it is important to know your committee and to glean the best practices from the positive outcomes that were related to that committee – they can provide a blue print for a new sponsor in that treatment category.

Let’s turn away from those numbers to content and delivery.

There is a sweet spot in AdComm preparation to be realized at the intersection of having really good data with having really good communications and delivery.  Can you get a positive outcome with good data and bad communications?  Yes, you probably can.  Can you get a positive outcome with bad data and really good communications.  No, you probably cannot.  Still, the place where you are best off is within the sweet spot of good data and good comms.

Why?  The content of this meeting echoes on long after everyone leaves the room.  It is important to remember that the AdComm is where branding for the product takes its first breath.  It is here that the public is really being introduced to the compound for the first time – all the more reason why communications place an important role.  That is the focus on the first part of the talk.

When it comes to fashioning the actual presentation, the presenters have more at hand than the task of conveying a simple presentation – they need to build a convincing case on the need for the compound, and that there is a favorable risk/benefit ratio.  On this front, it is a great pitfall to get lost in the weeds, without thinking about the entirety of the case being made.

In the end, while most people treat this as a scientific meeting – and it is – it is also important to look at it like an adversarial proceeding.  There is a judge (the Chair), there is a jury (the AdComm), media cover it (FDA beat reporters and trades), there is a prosecutor (FDA reviewers) and the sponsor is the defense.  Witnesses may show up as special experts or speakers at the Open Public Comment period.  That said, it is important that you be able to present your evidence-based best case.  In part 2, more on that topic.

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