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# FDA Integrity, Decision-Making at Risk: Blog
- URL: https://www.fdaweb.com/fda-integrity-decision-making-at-risk-blog/
- Published: 2025-04-22T12:00:00.000Z
- Updated: 2026-09-14T15:09:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159042

FDA Matters founder **Steven Grossman** says enough has changed in the Trump administration since **Martin Makary** accepted the nomination to be FDA commissioner in 11/2024 that he is facing a situation in which the agency’s integrity and decision-making are at risk. Writing in his organization’s blog, Grossman [says](https://www.fdamatters.com/fdamatters/fda-and-politics-an-unhealthy-combination?ref=fdaweb.com) it will be up to Makary to “either be the bulwark against politicization or to defer to his boss (HHS secretary **Robert F. Kennedy**, Jr.,) and the prevailing ethos of the new administration.”

Grossman says Makary presumably believed when he agreed to become commissioner that as a physician, healthcare quality and outcomes researcher, and self-styled iconoclast, he would be able to function well in Trump 2.0.

He says he doubts that Makary anticipated that the 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.

He also could not have foreseen, Grossman writes, that the value of public and private investment in life sciences and health would be so dramatically devalued in March and April of 2025, or that his staff would be cut by more than 20% via random and arbitrary reductions in force. “He could not have foreseen,” Grossman adds, “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.”

Further, Grossman says, he doubts that when Makary agreed to become commissioner he intended to fill the agency with political appointees, politicize agency decisions, or abandon good science.

Traditionally, the blog notes, the commissioner stays out of product decisions as does the HHS secretary. Those decisions are made by Center directors, who have never been political appointees, and who try to adhere to what the review team decides, perhaps with guidance from an advisory committee. “Product approvals should be based on science, not politics,” he states. “FDA’s process, while not always perfect, is intended to reinforce that. So far, no line has yet been crossed…. Nevertheless, pressures are building. The leadership ranks have been thinned considerably, and more appointments are coming. Also, presumably, a backlog of decisions has been growing since January.”

Grossman writes that as far as he can tell, there are no legal barriers to politicizing FDA. Thus, he concludes, the issue is whether, despite deeply rooted tradition and good common sense, 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,” Grossman says, “and await evidence of which course of action they pursue.”