For most of us, 2025 was a revelation. Things that we thought impossible (for example, abolishing federal employee unions) proved remarkably easy to do by fiat. Little or no deference was granted to rules and procedures that we all imagined would stand in the way…or at least provide a significant speed bump to slow things down.
The Trump “secret sauce” is to “flood the zone” with actions and proposals that combine the Administration’s obsession with norm-breaking (often for its own sake) with a total disinterest in conforming to federal statutory process requirements (Administrative Procedures Act and Federal Advisory Committee Act, among others). Even now, it is hard to focus on the shocking and deadly spread of measles or the worst flu season in thirty years, while ICE and Greenland are deservedly consuming most of the nation’s collective mindshare.
It is not hard to predict that 2026 will be “more of the same,” not least because flood the zone was a highly effective strategy for the Administration in 2025. If anything, based on the pace of public health pronouncements since January 1, we should expect the pace to accelerate throughout 2026.
Just one year ago, my early 2025 Predictions focused on how the first year of Trump 1.0 might be a guide to what would happen in the first year of Trump’s new term. My January 24, 2025 column was themed: “Keep Calm and Carry On: Lessons from Trump 1.0” (here).
I urged the stakeholder community and, particularly FDA employees, not to pre-judge how much FDA would be affected by the new Administration. I anticipated significant change but also noted that 2017 had been far less disruptive than many had feared.
A few days into the new Administration (Trump 2.0), it has become clear that objectives are the same [as in 2017], albeit rolled into the rubric of “less government.” What we are seeing…is more executive orders and directives that are 1/ conceptualized with greater sophistication and 2/expressed with more urgency and determination.
Even still, I am experiencing a strong sense of déjà vu rather than some wholly new sense of peril for FDA. Although the ultimate outcomes in 2025 may be quite different—even quite a bit worse– the challenges are mostly ones FDA has seen before in 2017 and in the later years of Trump 1.0.
What I didn’t anticipate was the rapid onslaught and profound impact of DOGE. The lay-offs announced on Valentines Day and then again on April Fool’s Day brought severe disruption, not just a loss of personnel. Every week, it seemed, FDA was flooded with new challenges without much time to understand or react to the previous ones.
It never got easier to anticipate and respond to each of the Trump Administration’s moves. Their commitment to change (at virtually any cost) was strong in 2025 and not foreshadowed by what the FDA had experienced in 2017.
The most unexpected element of 2025 was the Administration’s far-reaching commitment to norm-breaking (FDA Is Built on Predictability and Expertise, Not Norm-Breaking). In the case of the FDA, the agency’s science-based decision-making process was decisively undercut by the Administration’s disinterest in following processes (such as advisory committee and “notice and comment” rulemaking) that are essential to a fair and effective agency (2025 Topics Pertinent for 2026).
My Predictions for 2026 (as of January 21, 2026). The agency has one fate in 2026 for public health and scientific policy and a different one for product safety and product review.
Public Health and Scientific Policy: I expect the top issue for 2026 will be the further erosion of “science-based decisionmaking” at FDA (The CDC-ification of FDA). There are probably more facets, but I see three main parts to this
- Lack of commitment to process (policy by press release, few, if any Advisory Committees, abandonment of bottom-up product evaluations),
- Lack of adherence to rules of scientific interpretation (here), and
- Conclusions and decisions preceding (or divorced from) evidence.
The hot-button issues will continue to be about vaccines. Only two things can change the trajectory, neither likely:
- Senate opposition grows and finds levers to affect HHS and FDA policies (hard to accomplish if Secretary Kennedy does not testify in front of Congress this year and HHS avoids other hearing by not nominating individuals for Senate-confirmable positions),
- Massive morbidity and mortality from vaccine-preventable diseases over the next 3 to 6 months combined with greater public support for vaccines (Wall Street Journal) creates enough public outcry to make vaccines a mid-term election issue that the White House and HHS cannot ignore this coming Spring and Fall (Vaccines and the Mid-Terms)
I wish with all my heart that these predictions are wrong. Unfortunately, at this time, I do not see where a more positive resolution of the country’s public health challenges will come from.
Operations–Food and Medical Safety and Medical Product Reviews. In contrast to public health and policy issues, my hopeful expectation is that the business of FDA will stay largely functional. My advice to stakeholders is actually the same as last year: keep calm and carry on.
I have been told that most of FDA’s staff working on food and medical product safety and product reviews are “overworked and understaffed but otherwise doing mostly the same work in mostly the same ways as before 2025.” In this view, the policy, public health, and vaccine issues are troubling on a lot of levels but give the misleading impression that progress has halted and the entire agency is in turmoil.
If this is accurate, then FDA can be seen as “mostly functional for most of its responsibilities for most of the time.” While I am skeptical, I am also hopeful this view is true.
Of course, public health, vaccines, and science policy do not operate separately from food and medical safety evaluations and the review of non-vaccine products. When they overlap, the results will be unpredictable and may be inconsistent from one instance to another and from long-term precedents. For new products caught in this situation, patient and consumer hopes, as well as large capital investments, may come to naught.
Final thoughts: There can be no doubt the administration will continue to flood the zone. For that reason, no prediction is safe from initiatives that are yet unforeseeable. In response, all we can do is to continue to fight for an FDA that is transparent (by traditional standards) and engages in science-based decisionmaking.
