FDA AdComm Activity in 2026

Last year media reports stated that FDA was going to move away from holding advisory committee meetings to consider the approval of new drugs and consequently there have been no meetings held since that were for that purpose.

However, last week FDA posted notice in the Federal Register that it would be holding two half-day meetings of the Oncologic Drugs Advisory Committee (ODAC), both for the purpose of considering approval decisions, to be held on April 30, 2026. A few observations are important in light of the new activity.

• First, the fact that the agency has let such a long stretch go by without holding a meeting indicates that while they are not held at the same level as they were previously, they still may be a factor in the approval of a drug and should not be counted out by drug developers. And in addition, given the lack of meetings over such a stretch of time, media interest in any meeting that does get scheduled may be heightened.

  
  

• Second, and perhaps in contrast, the agency has not been maintaining the committees. Each advisory committee member joints with an assigned expiration date to their term. The committees each have different numbers of members who serve at terms that expire on a staggered basis. However, a quick census of the current advisory committe rosters shows that no new advisory committee members have been appointed to committees since the new administration took office.

The lack of new appointments has occurred as terms have expired. The result as been a growing absence of members. There currently is no committee that has a full roster, with many or even most having less than half of their numbers. For its upcoming meeting, ODAC will be missing six of its fifteen members. It is possible that FDA may appoint temporary members to fill the gap and/or to address specific expertise needed for the discussion.

Bottom line: While the scheduling of an AdComm means that FDA does not rule out the use of an advisory committee meeting as part of the process of a drug approval, it does not appear at this point that the agency is maintaining the committee structure in a way that would indicate a full fledged return to their use. Further, the fact that so many vacancies exist would also indicate that if the agency does hold a meeting, the appointment of temporary members will give the agency a great deal of flexibility into the types of advisors used on a case by case basis in considering a new drug approval.