What's In Store for FDA AdComms in 2025?

When the Food and Drug Administration considers a new drug or biologic for approval, it often may call on panels of experts for input into specific aspects of the approval. For drugs and biologics, these experts are divided among several panels along therapeutic categories. For human drugs there are currently 18 active Advisory Committees (AdComms), each comprised of several individuals who represent a range of expertise within the category and most of whom are deemed "voting" members. FDA periodically conducts the meetings to consider either an approval associated with a drug company application or to discuss an issue associated with the safe and effective use of a medicine. There are a number of issues at play that may tell us some things to look for respecting AdComms in 2025, and there are some reasons to look back to get perspective on what has happened.

1. Volume Dropped from 2023 - During 2024 there were 13 AdComms held (dark blue bar) by FDA for the purpose of discussing an approval of a drug or a new indication for an already approved medicine, far below the number in 2023. It is worth noting two things in that regard, however. First, 2023 was a bit of an anomaly in the years since the beginning of the COVID pandemic when FDA shifted to virtual meetings. In fact, 2024 is much more in line with the volume of meetings that were held in 2020, 2021 and 2022. Therefore, while it does reflect a drop in volume, it is actually closer to the recent norm. And secondly, in 2023 FDA approved more New Molecular Entities (NMEs) - 55 in 2023 compared to 50 in 2024. The very nature of NMEs might present novel issues or questions about which the agency might want to seek outside expertise.

2. Parity Between Positive and Negative Outcomes - Again prior to 2020, there had been a trend seen in the previous three years where the recommendations made by the committees for or against approval were weighted with favorable outcomes. In 2017, 2018 and 2019, positive outcomes far exceeded negative recommendations. Then in a departure from that pattern in 2020, negative outcomes ran neck and neck or exceeded positive outcomes with 2023 again being the exception. In 2023, there were far more positive outcomes than negative among the 24 meetings, with 18 postive votes compared to just 5 negative votes and one meeting where there was no vote taken. In 2024, however, we saw an even split once again between positive and negative outcomes.

3. Non-Voting Meetings Increased - In early 2023, FDA Commissioner Robert Califf expressed a desire to reform Advisory Committee meetings so that, among other things, to have less attention and effort placed on voting recommendations and more emphasis on discussion from which the agency could come to a conclusion about the approval, though FDA staff were reported as stating that the vote was still a very important aspect of meetings. In 2023 there was only one meeting without a vote while in 2024 there were five such meetings. Given that both the FDA Commissioner and the head of the Center for Drug Evaluation and Research (CDER) will have new heads during the course of 2025, it is not clear whether the trend to fewer votes will continue or will return to the norm of meetings with votes. For the near term, whether or not a vote is held will likely hinge on the nature of the meeting and the opinion of the division head over the particular therapeutic category involved in the approval consideration.

   
   

There were no great differences in subject matter between 2023 and 2024, with the meetings to consider oncology medicines being the most frequent subject matter.

With a new head for Health and Human Services (HHS) as well as the National Institutes of Health (NIH) and for FDA and CDER, 2025 has a potential to see a great deal of change in the way new medicines are assessed and approved. These are, however, big ships that do not turn on a dime, but must be steered to any kind of large scale change in a manner that takes time. How soon during 2025 those changes may be come into focus depends on multiple variables. In a recent interview, Commissioner Califf signaled that FDA could experience a number of staff departures. If so, that increases the potential for change that could have both breadth and depth.