Q&A - November 24, 2025
This week’s questions (answers below):
Commissioner Makary appears to be on shaky ground with HHS and the White House. What is your reaction?
What is going on in food policy? Are we on the right track?
According to the Washington Post (here), Dr. Pazdur has several areas where he disagrees strongly with Commissioner Makary. How is that going to work out?
The newly-revised CDC website states that vaccines could be a cause of autism. What do you think?
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Recent columns:
Dr. Pazdur’s New Role at FDA: More Than Just Adding Stable Leadership (November 19, 2025)
Morale at FDA: Ready to Reboot or on a Downward Spiral? (November 11, 2025)
FDA Is the Department of Homeland Security for Food and Drugs (October 31, 2025)
States vs. Federal Rights: The Perennial Debate Over FDA and Preemption (October 24, 2025)
FDA and the Revolving Door: Much Ado About Nothing? (October 14, 2025)
Q&A Monday columns: Past columns—with lots of interesting questions and insightful answers—are here.
Q: Commissioner Makary appears to be on shaky ground with HHS and the White House. What is your reaction?
A: Over the last two weeks, there have been multiple news stories -- portraying the commissioner as under siege. Reportedly, the White House is concerned about leadership stability, and HHS is concerned that FDA is moving too slowly to revise vaccine policies. Allegedly, both are concerned that his public leadership is coming (at least in part) at the expense of his management and internal leadership responsibilities.
It is hard to know how much credence to give any of this. Leaking information--whether true or not--is a well-honed DC game. No place in the world does it better.
My first reaction is that the entire stakeholder community needs an attitude adjustment. We need to be rooting a lot harder for FDA (and therefore Dr. Makary) to succeed (All of Us Need to be Rooting for FDA).
To wit, 1/ whatever you think of the specific policies and actions that Commissioner Makary is pursuing, 2/ whatever you think of his leadership and management styles, and 3/ whatever you think of his “mission accomplished” approach to what are clearly initial program steps....we must speak our truth AND YET also make clear that we support his leadership of FDA.
“We all need to root for FDA success” because the alternative is far worse. I have now put a name to that fear: we must, at all costs, avoid the CDC-ification of FDA (Weedy Concerns Amidst a Flood of FDA Issues and Morale at FDA: Ready to Reboot or On a Downward Spiral?).
So far, Secretary Kennedy appears to be loyal to Commissioner Makary, even though the commissioner was chosen by President-elect Trump in November 2024, not by Kennedy.
If Commissioner Makary resigns or is forced out, his replacement will be chosen by Secretary Kennedy. The White House will influence the decision but will not force Kennedy to choose anyone he doesn’t want. The replacement will almost certainly make the situation worse for the FDA and the stakeholder community.
Q: What is going on in food policy? Are we on the right track?
A: Most days, the food policy headlines feature Secretary Kennedy, MAHA moms, and the consumer groups battling industry interests over two issues: 1/ ingredient and additive safety, and 2/ the role of ultra-processed food (UPF). Additives and UPF are long-term structural and market issues that will take a long time to resolve. Neither side is going to win outright. I hope someone — behind the scenes — is working on a grand compromise (States vs. Federal Rights: The Perennial Debate Over FDA and Preemption).
Meanwhile, we are not paying enough attention to hunger and food safety. These are short-term, near-crisis issues. Resolving them would be immediately impactful AND have long-term benefits.
If, as political pundits are saying, “affordability” is the most salient voter concern, then both parties should be eager to stabilize (dare I suggest, expand) SNAP. There should also be a halt to the “rationing by inconvenience” tactics that, in the name of program integrity, are intended to suppress new enrollments and disqualify current beneficiaries. (A Message to MAHA: Every American Should Have Access to a Healthy and Affordable Diet).
As to food safety, it is impossible to do too much and ridiculously easy to do too little. We should have zero tolerance for greed and negligence, which are the most common precursors of unsafe food. That baby food is back in the news reflects the difficulty of the challenge and the ongoing inadequacy of current efforts. The fixes will require resources and commitment that are lacking at this time (FDA Is the Department of Homeland Security for Food and Drugs).
Q: According to the Washington Post (here), Dr. Pazdur has several areas where he disagrees strongly with Commissioner Makary. How is that going to work out?
A. Only Commissioner Makary and Dr. Pazdur know what was discussed during their (reportedly) lengthy conversations before Pazdur accepted.
I imagine Pazdur discussed areas of disagreement and received sufficient assurances from Makary about his role. Likewise, I imagine that Makary talked about his vision for FDA and the pressures he is under from HHS and the White House. I presume Makary received sufficient assurances from Pazdur that they would be able to work together as a team.
Without such a conversation, why would Dr. Makary offer, and the known-to-be-reluctant Dr. Pazdur accept this appointment?
My FDA Matters column on Dr. Pazdur’s appointment and my expectations: Dr. Pazdur’s New Role at CDER: More Than Just Adding Stable Leadership.
Q: The newly-revised CDC website states that vaccines could be a cause of autism. What do you think?
A: I am shocked, as are hundreds of thousands of people who follow public health closely enough to have seen this atrocity of misdirection. CDC’s change of position is based on the flimsiest of rationale--it has never been proven that vaccines don’t cause autism.
On LinkedIn, I suggested that readers review my six rules of scientific thinking that Secretary Kennedy needs to learn (Give Briefings a Chance, Secretary Kennedy). The sixth states: you can’t prove a negative.
One prescient observation (from my earlier commentary) bears repeating:
"Part of the current disconnect between the secretary and CDC on vaccine policy is Kennedy's unwillingness to be briefed by expert CDC staff. I find it troubling and quite sad that briefings and briefing books are no longer valued at HHS.
Kennedy is at war with experts and the value they bring to problem-solving. We will all pay the price in policies that are destructive to our nation's well-being."