Having worked with a lot of companies to prepare for an FDA Advisory Committee (AdComm) , I track the activities of the committees in a database marking outcomes, votes and other characteristics. As part of a look-back series as we begin the new year, it seemed like a good area to provide an assessment – the profile of advisory committees for the past year and how it compares to the year before.
And in fact, looking back over 2017, AdComms did take on a slightly different complexion from the previous year.
- Total Meetings – In 2016 there were 22 meetings by committees that involved votes to consider new drug applications. By contrast in 2017, there was only one more meeting – a total of 23 scheduled where new products were being considered. However, one of those meetings ended up being withdrawn by the company and one of them was withdrawn by FDA (the agency thereafter approved the product without the meeting being held), meaning that there were 21 actual votes for the year.
- Which Committees Met With What Frequency – A total of 12 of the 18 human drug advisory committees met during 2016, with the most frequent being among the Psychopharmacologic, the Arthritis, the Endocrinological and the Anesthetic Committees at 3 meetings each. However, in 2017 there were only 8 committees meeting and there was far less of a spread. The lion’s share – 9 meetings – were by Oncologic Drugs Advisory Committee, followed by the Arthritis and Psychopharmacologic Committees at 3 each. In 2016 there were 4 joint meetings of committees and in 2017 there were 5 – in…