Advisory Committee Track Records

Needless to say, every time a product goes before an FDA Advisory Committee (AdComm), there are circumstances that make the deliberations that occur during that meeting a unique experience. A specific investigative compound being studied for a specific indication with its own clinical trial track record for safety and efficacy to consider by a large group of people of varied backgrounds to pass on a recommendation for its use, or not, in a therapeutic are that may be serious or not and where there may already be many existing choices or none. And those are just some of the variables.

I have worked many times over the years to help teams prepare for such meetings and the issues that will likely come up. It has involved everything from helping to message out the presentations that teams make in an advisory committee to speaker prep to researching the panel to preparing for various communications issues facing the compound or the sponsor.

Some of the prep involves looking at the environment very narrowly – examining a few issues close up – and some of the prep may be macro – how has this committee dealt with similar issues in the past? Do some committees present unique patterns? Who meets most often? Who approves more of what they see?

So I have put together yet another database – the FDA AdComm database to look at just a few of those questions and more. I have gone back through 2009 and compiled an overview of the meetings of all of the advisory committees related to drugs since then. While it is a work in progress, I thought I would share some of the preliminary topline numbers.

  • How Many AdComms have Occurred? By my count there have been 298 advisory committee meetings since the beginning of 2009;
  • How Many were Joint Meetings? Of those 298 meetings, 69 of the meetings have been joint meetings where a meeting occurs with members of another committee, often the Drug Safety Risk Management Committee – only 22 of those meetings have involved consideration of a product approval and of those 22, only 8 (36 percent) have been recommendations for approval;
  • How Many Meetings Involved Product Approvals? 170 AdComm meetings have been in regard to product approvals and of those, the product was recommended for approval 111 times – or 65 percent of the time;
  • Which Committee Had the Most Meetings? The Committee with the most meetings was the Oncologic Drugs Advisory Committee which met 42 times, only 23 of which were product approval meetings with 56.5 percent of those being recommended for approval;
  • Which Committee Had the Most Products Approval Recommendations? The Committee with the most product approval meetings was the Endocrinologic Drugs Advisory Committee which met a total of 33 times, but 27 of which were product approval meetings and 23 (85 percent) of those products were approval recommendations;
  • What Committee Met the Fewest Number of Times? The Pharmacologic Drugs Advisory Committee had only 4 meetings, 3 of which regarded product approvals and 2 of which were recommended for approval.
  • What Committee Had the Highest Percentage of Approvals? The Dermatologic and Ophthalmologic Drugs Advisory Committee had 5 meetings that involved product considerations and recommended approval for all 5 of them and so got 100 percent.

One final question being compiled – how many times did FDA go against the recommendation of the advisory committee? The answer to that question is still being researched and the data entered.

AdComm prep is very complicated, and I go about it from many angles. But this is one more way – a kind of fun way – to get a big picture and just one more little piece of data to throw on the pile. Besides, I always wanted to do it.

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