Post-Thanksgiving Analysis: Hot Questions and Intriguing Answers
FDA Matters subscribers often start their week with my Q&A Monday column. To join them, you can subscribe (free) at www.fdamatters.com. A substantial amount of new information surfaced during the often quiet Thanksgiving week, so I wanted to share an edited and updated version of yesterday’s (December 1) Q&A column.
This column addresses four issues:
Commissioner Makary’s standing with the White House and HHS and what would likely happen if he quit or was pushed out,
food policy priorities and the relative lack of urgency on hunger and food safety relative to other goals,
Dr. Pazdur disagreements with the Commissioner and why it has resulted in today’s retirement announcement, and
CDC’s implied support of a vaccine/autism connection and how anti-vaccine efforts have now spread to FDA.
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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 of FDA. ....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.
Additional Information: The question was raised to me: Is it possible to root for FDA and not root for Commissioner Makary? It is illusory—at this time and at this place—to imagine you can separate one from the other.
If Makary is forced out, he will be replaced by someone who is more overtly anti-vaccine, eager to eliminate access to drug-induced abortions, more enthused about playing favorites with drug and device approvals, less invested in renewal of user fee agreements, and totally confused by the idea that there might be national goals (drug pricing) that are not FDA goals.
This is reinforced by the recent appointment of a new chief deputy of CDC, who is strongly and publicly anti-vaccine. He is allegedly “the best of a bad lot of possible candidates.” Faint praise, indeed.
The CDC move also demonstrated the Administration’s awareness of how it can manipulate “Acting” designations, so that it could be months before a Senate vote on a new CDC director is required. I presume that a similar tactic would be used if Commissioner Makary were to leave.
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).
Additional Information: My Thanksgiving essay (here) mentions the particular debt we owe to FDA’s inspection and compliance staff. Last week also brought further revelations about the current infant formula crisis. I realize I need to write more often and more forcefully about the importance of improving FDA’s approach to the safety of food/drug/device processing, manufacturing, and distribution. We need to find the systems and resources to do a better job.
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? (updated today, December 2)
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.
Additional Information: Senior FDA leaders fighting among themselves publicly is rare, if not unprecedented. If true, it is terrible news and undermines the agency’s authority and its ability to deliver consistent, reliable decisions.
This morning’s (December 2) announcement that Dr. Pazdur may retire from FDA at the end of the month comes as no surprise if 1/ the Commissioner and Dr. Pazdur never discussed policy disagreements before the appointment and 2/ there was the prospect of unhealthy public fighting.
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 definitively proven that vaccines don’t cause autism.
On LinkedIn, I recently 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."
Additional Information: This past Friday, November 28, CBER director and FDA chief medical and scientific officer, Dr. Prasad, announced a number of changes in FDA’s approach to vaccines. Axios describes the specifics and implications here, noting the lack of substantiation for the “science” driving the new policies.
Bottomline: the CDC’s increasingly aggressive and peremptory anti-vaccine positions now have a parallel agenda and champion at FDA.
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Some recent columns that may interest readers:
Once Again, It is Time to Give Thanks to FDA (November 25, 2025)
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)
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