AdComm Activity for 2016 – How Did They Vote?

The number of new drugs approved by FDA last year fell – by many indicators. There were fewer new molecular entities approved and there were fewer press releases about approvals during the year compared to 2015. And consequently, there were fewer advisory committees held to consider new drug approvals, but only just.

It is always interesting to look and see what kinds of decisions Advisory Committees made this year regarding product approvals and how does it stack up to what we’ve seen in the past. Looking back through my database going back through 2009, what observations can we make? ┬áHere are a few.

  • Number of Product Approval Meetings in 2016 – By my count during 2016 there were 22 advisory committee meetings held to consider the approval of a new medicine. Last year there were 23 such meetings, though there was a much higher rate of drug approvals by the agency. That would indicate that a higher proportion of the new drugs approved by FDA this year had Advisory Committees than last year.
  • Rate of Approval Recommendations by AdComms in 2016 – Of the 22 meetings, the committee voted 19 times to recommend approval to the FDA for the new medication, and 3 recommendations against recommending approval;
  • Comparison of FDA Decision versus AdComm Recommendation – Of the 22 recommendations made by advisory committees, FDA ultimately went against the recommendation of the committee 4 times
    • In 3 of the 4 instances, FDA decided not to approve a compound where the recommendation had been for approval – in one of those 3 the vote had been a very close vote, in the other 2 the vote was split, but not close;
    • In 1 of the 4 instances, FDA decided to approve a compound where the committee had voted against the recommendation in a very close vote;
    • This year stands out a bit – the total of 4 decisions that were ultimately counter to Advisory Committee Recommendations meant that FDA went against the committee advice 18 percent of the time. In the August 2016 analysis looking at that question overall, it was found that on average FDA went against the advice of committee about 10 percent of the time.
  • Joint Committee Meetings – Of all the meetings to consider new product approvals, 4 were joint committee meetings of two committees. In all four instances, the candidate drug was seeking a pain indication and all involve the Anesthetic and Analgesic Drugs Advisory Committee with the Drug Safety and Risk Management Advisory Committee. In all four, the Advisory Committees recommended approval and FDA did approve three out of the four.

Technically, the year is not over. There are still 2 Advisory Committee meetings where recommendations were made and FDA has not made a decision. In fact, for a final tally of the year, of the 22 product considerations, there were 15 FDA approvals, 5 that were not and 2 still outstanding. That could alter the numbers related to the number of times that FDA went counter to an advisory committee recommendation.

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