Finally, Some Encouraging News from FDA
The most important questions facing FDA and the stakeholder community are:
After the lay-offs, RIFs, and voluntary departures, does the FDA have enough staff and expertise to fulfill the agency’s responsibilities?
If there are tasks and obligations that will not be met--or not met in a specified timeframe--will the agency address statutory, Congressional, and stakeholder concerns?
It will take a while for Commissioner Makary to have answers. When he does, I hope he will address them forthrightly and not increase the many uncertainties about the agency’s future and priorities.
Meantime, FDA Matters is monitoring the situation and can report some encouraging signs of progress.
Rehiring. We are starting to hear more reports about RIF’ed and laid off employees being asked to return to their old jobs. I have no idea whether this is a few or a lot of people. It is not ideal (actually quite cruel) to have fired a large number of people and only then start reviewing their remit to figure out who should have been retained rather than fired.
That said, callbacks are occurring and that is an encouraging sign for the agency. Among other things, it looks like the commissioner is upholding his promise to Congress that he would review all of the downsizing that occurred before he was confirmed.
User fees. Along with other commentators, I have had serious concerns about the future of user fees. That’s understandable given Trump/Kennedy/Makary projecting their views along the lines of “FDA is a sock puppet for industry.”
There are now some encouraging signs we can point to. Regulatory Focus reported[1] on Deputy Commissioner Grace Graham’s speech to FDLI last week in which she discussed some early thinking about restructuring user fees. Also, July dates have been announced for the first PDUFA and GDUFA public hearings.
Asked by a reporter to comment on concerns about Graham’s thinking. I replied “1/ you can’t get to the end unless there is a beginning and we weren’t certain there would be a beginning, 2/ no matter the starting position of FDA, it is a long negotiation and there is no reason at this point to believe that the end-product won’t be satisfactory to all parties, and 3/ the PDUFA agreements have evolved over 30 years and it is appropriate that a new administration is looking at how to improve the program.” I added: “All that said: this one is likely to be testier and more public than past negotiations….but the administration engaging the process is all good news.”
More Insights from the Commissioner About His Plans and Priorities. Commissioner Makary seems to have picked up the pace on talking publicly about his views. As we have all seen, he is smart and articulate.
He has some interesting ideas, which he delivers in an “I can get it done” breeziness that is refreshing. While we disagree about the likely impact of the RIF’s, he seems to understand the FDA cannot be run without a substantial and expert staff.
Whether you like what he says or not, having him out in public advocating for the agency is encouraging.
Staff Travel and Meetings. It’s not unusual for incoming administrations to limit employee participation in stakeholder meetings and tamp down or even freeze travel until new officials are in place. For a while it looked like the Trump administration might try to maximize the time during which things were halted.
I am hearing enough reports to believe things are going in the right direction.
Implementation of AI. AI is the future, especially for an agency like FDA that often receives reports that are thousands of pages long and relies on databases that might contain millions of data points. In particular, AI can help FDA make better regulatory decisions based on more refined and accurate information.
Commissioner Makary’s embrace of AI is encouraging news. There are legitimate concerns about relying on AI too quickly and without system refinement and validation. Details are scarce at the moment, so I am inclined to believe that the actual uptake will be appropriately spaced over time and not rushed.
Finally, there is some encouraging news from FDA. I am pleased to share it.
https://www.raps.org/news-and-articles/news-articles/2025/5/fda-deputy-commissioner-hints-at-potential-changes?utm_campaign=regulatory_focus&utm_medium=email&_hsenc=p2ANqtz-_rvGbKXqqfzLXRI-d3eFQauxxlA8mWMNMs_7z5LGbDSTAy7GqADQny6Z8sg6TPlJ6S2He5SoKuLXOWBbkfsd1njgOcFQ&_hsmi=362270950&utm_content=362270950&utm_source=hs_email