FDA and Politics: An Unhealthy Combination
Dr. Makary is a physician, healthcare quality and outcomes researcher, and self-styled iconoclast. When he accepted the Commissioner position in November 2024[1], I am sure he believed that Trump 2.0 would be a hospitable place to harness those personal attributes in the cause of a more effective, consumer and patient-focused FDA.
I am certain, as well, that at that time he would have wholeheartedly affirmed my mantra: FDA will be okay as long as it is committed to incorporating good policy, good medicine, good public health practices, and good science into all agency decisions.
A Lot Has Changed Since Dr. Makary Said “Yes” to Being Commissioner
From the perspective of last Fall, I doubt he anticipated that this Administration would devote itself so vigorously and globally to “norm-breaking.” Or that it would relentlessly pursue its positions with a highly politicized and deeply personal fervor.
Likewise, he could not have foreseen in the Fall of 2024 that the value of public and private investment in life sciences and health would be so dramatically devalued in March and April of 2025[2] or that his staff would be cut by more than 20% via random and arbitrary RIF’s[3]. He could not have foreseen that “radical transparency” would include frequent suspension of the “notice and comment” provisions of the Administrative Procedures Act, which are the bedrock of our government’s commitment to be inclusive of all views.
When Dr. Makary said yes in November 2024, I doubt he intended to fill the agency with political appointees or to politicize agency decisions or to abandon good science.
A Tradition of Keeping FDA Out of Politics
Traditionally—and this is a deeply imprinted cultural norm—the Commissioner stays out of product decisions. And so does the Secretary[4]. Such decisions are made by the center directors, who, to my knowledge, have never been political appointees. Even the center directors have tried their best (not always successfully) to keep the focus on what the review team decides, often with input from an advisory committee.
Product approvals should be based on science, not politics. FDA’s process, while not always perfect, is intended to reinforce that.
So far, no line has yet been crossed in 2025[5]. The three appointments announced this week are known quantities with strong ties to the agency[6].
Nonetheless, pressures are building. The leadership ranks have thinned considerably, and more appointments are coming. Also, presumably, a backlog of decisions has been growing since January.
As far as I can tell, there are no legal barriers to politicization. Specifically, FDA statutory authority is assigned to the Secretary, who has delegated it to the Commissioner, who I believe has delegated certain decisions to the center directors. All of these delegations can be withdrawn, in whole or part, at any time.
All of which is to say: the integrity of FDA and of FDA decisionmaking are at risk. It is up to Dr. Makary to either be the bulwark against politicization….or to defer to his boss and the prevailing ethos of the new Administration.
I am sure that some readers are saying: Steven, why are you putting this in writing? Do not give the new Administration any ideas. To which I can only respond: nothing in this column is a surprise to the Administration, HHS, or FDA.
The issue is whether–despite deeply rooted tradition and good common sense--Dr. Makary and his bosses want to politicize the agency. It is not whether they have the authority or means to do so.
Along with the rest of the stakeholder community, I have a preferred outcome and await evidence of which course of action they pursue.
https://hub.jhu.edu/2024/12/01/marty-makary-fda-appointment/
For example, if one were to believe (I do not) that life sciences should be advanced solely in the private sector and not publicly-stimulated through NIH, then you still need to support FDA. Without an expert and credible FDA with predictable standards and well-understood process, there will not be much private investment in the life sciences.
https://www.fdamatters.com/fdamatters/random-arbitrary-rifs-drive-the-initial-makary-agenda
In the rare instances this has been challenged, it has always been around reproductive issues and products. To the best of my knowledge, it has always been resolved without impacting issues or products beyond reproductive ones.
With the possible exception of one review of a vaccine that is past its PDUFA due date. This is a serious concern, but not sufficient by itself to decide that FDA has been politicized.
https://www.statnews.com/2025/04/22/fda-marty-makary-new-leaders-deputy-commissioner/