Sorting it Out – FDA AdComm Review for 2019

Has FDA been holding enough AdComms? There have been a large number of drugs approved in the past year, but there has not been a corresponding increase in the number of advisory committees staged by FDA. Late in 2019, I had a posting about the fact that it looked like FDA was headed to a year where it held fewer FDA Advisory Committees than it had in years past. However, it was premature. FDA did manage to squeak in a few more meetings in December and brought the total up, though it was still well below the number of meetings held during many of the years between 2012 and 2019.

More about the volume of meetings in a moment. First let’s look at those that were held – what they considered and what the outcomes were. How man meetings, how many about drug approvals and how often was FDA in agreement with committees – and more…

  • There were a total of 28 meetings for the 2019 calendar year
  • Of the 28 meetings, 23 were held to consider an approval of a medicine, seven of which were sNDAs or sBLAs while the balance were NDAs or BLAs – the other five meetings were to discuss specific issues of safety or policy issues
  • Of the 23 NDA/BLA/sNDA/sBLA meetings, committees recommended approval for 17 medicines, did not recommend approval of 5 and 1 of the meetings was cancelled;
  • Of those 17 drugs that Advisory Committees approved during 2019, FDA approved 12 of them; however three of them that got committee approval were instances where FDA decided against the recommendation of the committee and did not approve the application; and there are two applications where a decision has not been announced;
  • In fact, there were a total of 4 examples of FDA going against the recommendation of the committee – 3 where FDA declined to approve against a recommendation (mentioned above) and 1 where FDA approved the drug in spite of the committee’s recommendation against approval – that would mean FDA disagreed with the Advisory Committee recommendation just over 14 percent of the time
  • Four of the meetings involved joint sessions with the Drug Safety Risk Management Committee, only one of which was to consider an NDA for a new product
  • The committee that met the most was the same as in 2018 – the Oncologic Drugs Advisory Committee met six times this year, though that was down from nine last year; the next highest level of activity was also the same as last year – the Antimicrobial Drugs Advisory Committee met five times (three of them product-related) down from six meetings last year.

In addition to having a few more meetings at the end of the year, FDA approved a bunch of new molecular entities in the closing weeks of 2019 and in fact, is approving drugs more quickly, which was an aim of the policy changes made by Congress. Also, lately there has been some question regarding the higher rate of new approvals versus the lower number of FDA advisory meetings held. There have also been some approval decisions made by the agency that have also attracted criticism and concern. It is possible that this kind of scrutiny on the process could result in the staging of more advisory committees in 2020. We’ll have to see.

Photo by Laurynas Mereckas on Unsplash

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