Q&A - September 1, 2025
This week’s questions:
What’s at stake when a CDC director won’t sign off on the Administration’s vaccine policies, is fired, and several senior center leaders resign?
What happens next at CDC?
What are the possible impacts of the CDC situation on FDA and NIH?
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Q: What’s at stake when a CDC director won’t sign off on the Administration’s vaccine policies, is fired, and several senior center leaders resign?
A: I try to avoid hyperbole and am sensitive to recency bias....so I won’t say the CDC situation is the worst I have seen in my many years in DC. It is undoubtedly near the top.
The President Leads the Executive Branch. The only elected members of the executive branch are the President and Vice President. Subject to Congress (enacting laws or exercising the power of the purse) or the Supreme Court (ruling on lawsuits involving decisions made by the Executive Branch), they are free to interpret their election mandate however they wish. That includes ordering “subordinate officials” to carry out Administration policy.
Subordinate Officials Take an Oath of Office. However, those subordinate officials took an oath of office to uphold and defend the Constitution and to “well and faithfully discharge the duties of the office upon which I am about to enter.” Independent of the substance of the matter, Dr. Susan Monarez, CDC Director, was being asked to announce a national policy on behalf of the CDC that had not, in fact, been approved or even vetted by the CDC. Presumably, she felt that doing so would force her to violate her oath of office. So, she refused to sign off on the proposed vaccine policies.
Priorities beyond the Oath of Office An extreme but not outlandish interpretation of “policies narrowing vaccine availability and accessibility” is that they could lead to mass civilian casualties (mortality and morbidity). The short-term risk is more likely to be measles than COVID, but the long-term risk of a new pandemic to an unprepared society has been widely discussed.
Viewed in this light, the Director of the CDC may have additional moral and legal imperatives — beyond their oath of office — to reject vaccine policies that leave a large portion of the population vulnerable. If mass casualties were to occur, “I was just following orders” would not be a sufficient defense.
Q: What happens next at CDC?
A: In the interim, Jim O’Neill, HHS Deputy Secretary, will also serve as Acting Director of CDC. Under the Vacancy Reform Act of 1998, he can serve in this capacity for up to 210 days (until mid-to-late March 2026). He was a political appointee at HHS in the second Bush and Trump 1.0 administrations, so CDC is familiar to him. Reportedly, he is pro-vaccine but also, reportedly, he has a good working relationship with Kennedy. Like several HHS leaders, he was harshly critical of the Biden administration's handling of COVID.
Q: What are the possible impacts of the CDC situation on FDA and NIH?
A: Nothing necessarily changes for Dr. Makary and Dr. Bhattacharya (NIH). They already knew--and needed no reminder--that they are employed “at will” and can be fired without cause and at any time by the HHS Secretary and the President[1].
That’s inherent in their jobs and was true for their predecessors, as well.
Hopefully, they now have months of experience in managing their relationship with Secretary Kennedy and have gained his trust. In that time, there are undoubtedly positions they have taken that were ordered by the Secretary...and others in which they anticipated his views and incorporated them on their own initiative. (note: before anybody thinks ill of this--almost all jobs, public and private, require managing your boss and anticipating his/her responses to your own planned decisions and actions).
The future we are experiencing now was foreseeable. Two months ago, mindful of the delicate political balance that all agency heads must navigate, I wrote “Commissioner Makary is operating in a political environment that is arguably more challenging than any FDA commissioner has faced since the agency’s creation in 1906.”
The column, “All of Us Need to Be Rooting for FDA” (https://www.fdamatters.com/fdamatters/all-of-us-need-to-be-rooting-for-fda) raised some eyebrows and resulted in it being widely reprinted.
My analysis and point-of-view have not changed: a stable and functional FDA, regardless of its flaws, will be better for the American public and stakeholders than a chaotic and dysfunctional agency. The same can be said of NIH.
[1] If so inclined, nothing prevents Secretary Kennedy from treating FDA and NIH the same way he has just treated CDC. Notably, many HHS statutes affecting HHS’s jurisdiction direct the Secretary (not subordinate officials) to take implementation actions. Agency heads can act because authority is delegated to them by the Secretary. Little prevents the Secretary from withdrawing the delegations of authority and making most or all of the decisions now made by the heads of CDC, FDA, and NIH. For everything else, he can appoint an acting head as he has with CDC.