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# FDA May Go Months Without Senate-Confirmed Commissioner: Analysis
- URL: https://www.fdaweb.com/fda-may-go-months-without-senate-confirmed-commissioner-analysis/
- Published: 2026-07-22T12:00:00.000Z
- Updated: 2026-09-14T13:43:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161499

FDA could remain without a Senate-confirmed commissioner for months as political and procedural hurdles complicate efforts to fill the agency's top post, according to an [analysis](https://www.pharmavoice.com/news/why-the-fdas-top-spot-could-sit-empty-for-months-ahead-of-midterms/825830/?ref=fdaweb.com) published Wednesday by *PharmaVoice*. More than two months have passed since former FDA commissioner **Marty Makary** resigned, and the Trump administration has not announced a nominee to permanently replace him. **Kyle Diamantas** continues to serve as acting commissioner.

Experts interviewed by *PharmaVoice* said the absence of a permanent leader could prolong uncertainty for drugmakers, medical device companies, and other regulated industries as they await clarity on the agency's long-term regulatory priorities.

"Transition delays and really, any uncertainty in leadership, are not good for the industry and not good for the public," **Genevieve Kanter**, an economist and associate professor of public policy at the University of Southern California, told *PharmaVoice*. She said companies may delay clinical trials, product submissions, and other investments until there is greater policy stability.

One factor that could delay a commissioner’s confirmation is the Senate’s limited legislative calendar, which poses a significant obstacle to seating a new commissioner before the 2026 midterm elections. **Jordan Brossi**, a senior public affairs advisor at Holland & Knight, told *PharmaVoice* that fewer than 30 legislative days remain before the election, leaving little time to process a nomination for one of the federal government's most prominent health leadership positions.

Even if the White House were to announce a nominee soon, the confirmation process — including White House vetting, Senate Health, Education, Labor and Pensions (HELP) Committee review, and a full Senate vote — typically requires at least two months under favorable circumstances.

*FDA Matters* founder **Steven Grossman** also says it’s hard to imagine a new FDA commissioner taking office before December 2026, and the early months of 2027 would be even more likely. Writing in his online newsletter, Grossman says, “It’s highly unlikely that anyone will be nominated soon, and no one will be confirmed quickly.” It’s his opinion that acting commissioner **Kyle Diamantas** is a good choice for the position and will likely serve for a significant amount of time ([see earlier story](https://www.fdaweb.com/dont-expect-a-new-fda-commissioner-soon-grossman-column/)).

Media reports have said the White House is considering a final list of three contenders to be FDA commissioner — White House adviser **Heidi Overton**, oncologist and health system executive **Jeffrey Vacirca**, and Defense Department health affairs official **Stephen Ferrara**. *PharmaVoice* reported that others are also under consideration, including former FDA commissioner **Stephen Hahn**, and former HHS Assistant Secretary for Health **Brett Giroir**,

The report notes that lengthy leadership vacancies are not unprecedented. The FDA previously operated for 22 months without a Senate-confirmed commissioner during the **George W. Bush** administration and for 13 months during the Biden administration, relying on acting commissioners to oversee agency operations.

While acting commissioners can manage the FDA's day-to-day activities, analysts told *PharmaVoice* they may have less authority — or less perceived authority — to implement lasting policy changes, raising questions about the durability of initiatives launched under Makary.

"The big question is whether the policies launched during the Makary regime will stick around," Kanter told the publication.

The leadership uncertainty comes as the FDA faces several significant policy issues, including preparations for the next reauthorization of the Prescription Drug User Fee Act (PDUFA) and other user fee programs that provide a substantial portion of the agency's funding. "The stakes for the FDA are high," Brossi told *PharmaVoice*. "The user fee act processes are considered must-pass, given the significant ramifications for both the FDA and regulated industries should authority to collect user fees expire."

The *PharmaVoice* analysis also noted that recent leadership turnover and policy debates have contributed to broader questions about regulatory consistency and public confidence in the agency, concerns that could persist until a permanent commissioner is confirmed.