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# FDA Leadership Upheaval Yields Uncertainty: Post
- URL: https://www.fdaweb.com/fda-leadership-upheaval-yields-uncertainty-post/
- Published: 2026-06-23T12:00:00.000Z
- Updated: 2026-09-14T13:41:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Drugs, #legacy-id-D5161355

A *Skadden Insights* [post](https://www.skadden.com/insights/publications/2026/06/insights-june-2026/fda-leadership-upheaval?ref=fdaweb.com) says the departure of former FDA commissioner **Marty Makary** and several of his senior executives has led to regulatory uncertainty in regulated companies. “Many of the initiatives that defined the Makary era were never enshrined in formal rules or guidance, but rather were announced by press release, podcast, or at public events,” the post says. “With their principal champions now gone, FDA-regulated companies are asking what will happen to these programs, as well as what the overall tenor of the agency will be under new leadership.”

Skadden says Makary made extensive use of “podium policy,” announcing significant changes through informal channels rather than through the formal notice-and-comment rulemaking process. Where FDA once channeled its most consequential shifts through *Federal Register* notices, formal guidance documents, and rulemaking, the post says, the Makary FDA made many major policy pronouncements via press releases, journal articles, podcasts, and social media.

“The practical consequence is significant,” Skadden continues. “Policies adopted outside of formal pathways are more vulnerable to reversal by future administrations and less likely to withstand judicial scrutiny. Without an administrative record, the durability of these policy changes is uncertain. With Makary’s departure and the exit of nearly all of his senior deputies, these informal initiatives carry a heightened risk of reversal or legal challenge, a factor that regulated companies may wish to weigh in their regulatory planning.

The post lists these Makary initiatives whose future is now uncertain:

- the National Priority Voucher program
- single clinical trial standard;
- one-day inspection pilot;
- real-time clinical trials initiative; and
- integration of artificial intelligence into FDA processes.

The post concludes that while acting commissioner **Kyle Diamantas** is closely tied to the Trump administration, he has had a stabilizing influence on an agency in crisis. It says Diamantas has signaled a deliberate intent to reorient FDA around its career scientific workforce. “Especially for companies with development programs in the rare disease and vaccine spaces, areas that were the focus of extreme deviations from the normal scientific practice under Makary, the reemergence of a more stable and science-driven regulatory partner may be a welcome change.”