A cornerstone of my predictions for 2026 (here) was that:
- anything that touches upon public health (especially vaccines) or diet and nutrition was likely to have a particularly difficult and unpredictable year, and
- food and medical product safety programs and product reviews that do not involve public health or diet and nutrition, will be largely unchanged and largely predictable, albeit conducted with less staff, with longer and more frequent delays, and with a lot of frustration at FDA and among stakeholders.
This is a “testable hypothesis.” At appropriate intervals, I will provide updates on its predictive value for developments at the agency. In the meantime, feedback is welcome.
That my analysis predicted divergence was a surprise–at least to me. When I have written about morale at FDA (most recently here), I have always talked about the agency as a whole. This made sense — the reputational blow to the agency in 2025 affected everyone who worked there, whether or not they still had a job by year’s end.
However, as Fall led into Winter… 2025 into 2026… as CDC-ification (here) began to affect parts of the agency more than others…I started to see a pattern emerging. Ironically, it wasn’t the traditional dichotomy between food and medical products.
Rather, anything at the agency involving public health or diet and nutrition is becoming increasingly problematic, while (with a few exceptions) the rest of the agency remains operational and may be edging toward an uncomfortable, understaffed normalcy.
I expect to find much more dysfunction, policy swings, and unpredictable actions regarding public health, vaccines, and diet and nutrition. However, that doesn’t mean there won’t be some of the same in the other parts of the agency–just at a far lower rate and with less consequence.
Additional thoughts:
What is the evidence that some parts of the agency are moving toward understaffed normalcy?
The recently released Endpoints Signal Biopharma Sentiment Index (here) makes it possible to argue either way. There is anger regarding regulatory chaos, but it is difficult to determine whether this reflects a reaction to policy shifts and the loss of senior leadership, or to their own day-to-day experiences with the agency. There is certainly an argument that the tumult being created by public health and diet and nutrition issues is giving the misleading impression that progress at FDA has halted and the entire agency is in turmoil.
If, indeed, large swaths of the agency are moving toward understaffed normalcy, it would be good to get the word out. The perception of regulatory chaos is spooking product developers and investors. Maybe they don’t move forward at all, but there is also the risk that less innovative projects are being funded “just to play it safe.”
Are there areas other than vaccines, public health, diet, and nutrition, where the potential for unpredictable agency actions might be high?
Reproductive health and abortifacients are obvious choices. They are never far from the top of the list of FDA’s controversial issues.
Another potentially problematic area is cell and gene therapy and, more generally, safety and efficacy standards for orphan drugs. FDA leadership has expressed interest in pushing innovation. Yet there is a perception that current applications in this area are being held to unnecessarily high standards, given the obvious limitations of small trials.
A few weeks ago (here), you wrote that “I expect the top issue for 2026 will be the further erosion of ‘science-based decisionmaking’ at FDA.” How does that relate to your hypothesis that there are “two FDAs” moving in divergent directions?
It is not a coincidence that I illustrated this point using vaccines as an example. So, I think both can be true
The difference is that food and medical product safety and the bulk of (non-public health) product decisions rest on science that is not controversial and/or for which there is little pay-off in being contrary. We have possibly seen two exceptions: safety of antidepressants during pregnancy and hormone therapy for menopause. I didn’t follow either closely, so I can’t give a view on the merits, although I have been critical of the process.
