Got a New Drug Approval in 2025? Some Food for Thought.

FDA Great Room - Venue for FDA AdComms

There has not been a single FDA Advisory Committee meeting held by the agency nor has one been scheduled since the new administration took office. If you have a new drug that is coming up for FDA approval this year, you may be wondering how current events may be shaping the outlook. Because the approval process, at least in connection with FDA Advisory Committees (AdComms) has been in limbo, that is a good question.

While there have been a myriad of issues potentially impacting the flow of the pipeline in the long term - such as cuts to research grants at NIH, in the near term the process represented by FDA AdComms stand out. Here are a few considerations:

1. Limited Communications - At the outset of the new administration a communications freeze put into place over multiple government agencies, including FDA. It had no clearly defined term and how it has played out seems to vary for different agencies within Health and Human Services (HHS). With the advent of the freeze to date FDA has issued only seven press releases, only one of which announced an approval. The FDA Roundup, a posting which was previously published about three times a week only resumed publication February 28 representing something of a partial thaw in the freeze. Included under the communications blanket were Federal Register Notices which are necessary to announce upcoming meetings being held by FDA.

   
   

2. AdComm Inactivity - As noted above, no new AdComms have been held and none have been announced (notice of an FDA AdComm should technically occur no sooner than 15 calendar days prior to the meeting). After a spell of several weeks, FDA has resumed some very limited publications in the Federal Register, none of which have been connected with a meeting of an FDA Advisory Committee. In addition, at the outset of the communications freeze, FDA cancelled or postponed previously scheduled AdComms, without future dates named.

   
   

   Coincident with the lack of any scheduled meetings, it is important to note that there are also a large number of vacancies on the committees. By my count there are 199 advisors on the 17 human drugs advisory committees, with 67 current vacancies among them - a 34% vacancy rate. And that number could increase in the coming weeks. There are many advisors on the committees with terms that are about to expire. Further, both the new Secretary of HHS and the new FDA Commissioner have expressed criticism of the relationship between the agency and industry generally and with respect to potential conflicts of interest specifically, putting into question how that outlook might impact the choice of future committee members.

   
   

   Membership apart, the very function and scope of AdComms by HHS in general has been a focus of concern expressed by the new Secretary who has stated an intention to remove conflicts of interest from committees advising HHS. Recently NIH began publishing notices in the Federal Register of upcoming advisory committee meetings. FDA has not.

   
   

   When FDA is holding and AdComm, there has always been an opportunity for ample public input into the process. This happens when the agency opens a docket for written commentary as well as during the AdComm itself when there is an Open Public Comment period held to receive public input. The new Secretary has also been quoted in media as saying that he would seek to eliminate public comment in HHS decisions. It is not clear if this will ultimately reach to FDA and whether it would impact public comment before and during AdComms.

   
   

3. PDUFAs and New Molecular Entity Approvals - In this regard, there is good news and there is bad news.

   
   

   Some may have been concerned that the sweeping cuts to the federal workforce through layoffs and buyouts might have a negative affect on FDA's ability to consider new drug applications on a timely basis. In reviewing 18 decision publicly known PDUFA dates since the third week of January, the overwhelming majority have come in on time or before the assigned date. There have been a few delays, but not more than is usual. That is one piece of good news.

   
   

   And another piece. Regarding the approval of new molecular entities (NMEs), thus far in the year, there have been 5 NME approvals as of this date, all of which occurred on or prior to the assigned PDUFA date. The bad news is that there hasn't been such an approval since mid-February and so far, 2025 is behind where we were by this time in 2023 (10), 2022 (9) and 2021 (13).

   
   

   There is a good deal to digest and a lot more to consider given the impacts of the current transition. But while many questions do abound, it would appear at this point that even in the absence of AdComms, there has been a regular flow of new approvals.

There are so many moving parts to consider in the bigger picture of drug approvals. At this stage there are many possibilities for change - and many questions raised by the statements and actions taken thus far, but there is no clear picture emerging as yet to tell what the impact may be on the FDA advisory committee process - from membership to role to public input to timing.