Three former FDA chiefs say DOGE and Makary-era exits cost the agency knowledge it will take years to restore
Three former FDA chiefs said DOGE's 3,500 job cuts and a larger exodus under Marty Makary cost the agency institutional knowledge. Ned Sharpless said companies he works with now meet more junior reviewers.
The Scientist · Science desk
Five claims. Supported: the exodus cost knowledge that will take years to restore; rebuilding will take time. Insufficient: DOGE's 3,500 cuts preceded a larger exodus under Makary. Contested: Sharpless's report of more junior reviewers; Gottlieb's view that confidence has returned.
- Supported Three former FDA chiefs, Rob Califf, Scott Gottlieb and Ned Sharpless, spoke at the STAT Summit in Boston on Wednesday and criticized former FDA officials who oversaw a staffing exodus that robbed the agency of institutional knowledge that will take years to restore., claim 1
- Supported Even with new leadership, the former officials warned that rebuilding the agency will take time. They advised Overton, if confirmed, to focus not just on rehiring staff, which the agency has already started, but on reassuring officials that they will be protected from political meddling or further firings., claim 6
- Insufficient evidence The DOGE cuts of 3,500 workers preceded a larger staff exodus under the leadership of former FDA Commissioner Marty Makary., claim 14
- Contested Sharpless said that the companies he works with as co-founder of Jupiter BioVentures often now find themselves in meetings with more junior and less experienced drug and medical device reviewers., claim 9
- Contested Gottlieb said: "Now we have, I think, sensible leadership that's doing smart things in the organization. I think things have gotten back to people feeling confident that the regulatory agency is making rational decisions.", claim 13
| Claim | State | Claim number |
|---|---|---|
| Three former FDA chiefs, Rob Califf, Scott Gottlieb and Ned Sharpless, spoke at the STAT Summit in Boston on Wednesday and criticized former FDA officials who oversaw a staffing exodus that robbed the agency of institutional knowledge that will take years to restore. | Supported | 1 |
| Even with new leadership, the former officials warned that rebuilding the agency will take time. They advised Overton, if confirmed, to focus not just on rehiring staff, which the agency has already started, but on reassuring officials that they will be protected from political meddling or further firings. | Supported | 6 |
| The DOGE cuts of 3,500 workers preceded a larger staff exodus under the leadership of former FDA Commissioner Marty Makary. | Insufficient evidence | 14 |
| Sharpless said that the companies he works with as co-founder of Jupiter BioVentures often now find themselves in meetings with more junior and less experienced drug and medical device reviewers. | Contested | 9 |
| Gottlieb said: "Now we have, I think, sensible leadership that's doing smart things in the organization. I think things have gotten back to people feeling confident that the regulatory agency is making rational decisions." | Contested | 13 |
What happened
- At the STAT Summit in Boston, Rob Califf said DOGE "will go down as one of the biggest disasters in American history."
- Makary resigned in May, and White House official Heidi Overton, nominated to replace him, has not yet had a Senate confirmation vote.
- Scott Gottlieb summed up the effect of the departures in five words: "You lost a lot of institutional memory."
- The panelists also said the agency may be turning a new leaf now that certain high-profile officials, including Makary, have gone.
- All three urged the FDA to stay on its core mission, and Sharpless said changing drug prices or addressing vaccine hesitancy is outside its mandate.
Why it matters
- exposure A company planning its FDA meetings has no published measure of how much reviewer experience has changed, only Sharpless's report from his own portfolio.
- contradiction The panel describes lasting damage and restored confidence together, and both rest on the impressions of former agency heads.
- constraint Rehiring has begun, yet the panel tied recovery to protecting staff from firings and political meddling, a promise that would come from a nominee the Senate has not voted on.
The junior-reviewer observation is the closest thing in the panel to an effect a drug developer would feel across the meeting table. It rests on the companies Sharpless works with as co-founder of Jupiter BioVentures [9]. That is one portfolio.
The thing this doesn't tell you is the size of the loss. The only count in STAT's report is the 3,500 DOGE cuts, and the exodus under Makary that followed is described as larger [14]. The report does not include the number of reviewers who left, how the experience of review teams changed, or whether review times moved. With no comparison against turnover in earlier years, "institutional knowledge" is a judgement from people who have run the agency. Their standing is real: Califf led it under Obama and Biden, Gottlieb served for part of the first Trump administration, and Sharpless was acting commissioner near the end of it [8].
The recovery claim has the same form. Gottlieb praised Kyle Diamantas, now acting commissioner, and policy lead Grace Graham [12]. "Now we have, I think, sensible leadership that's doing smart things in the organization. I think things have gotten back to people feeling confident that the regulatory agency is making rational decisions," Gottlieb said [13]. Califf was briefer: "I think the sowers of chaos came and went" [11]. Both are impressions from former agency heads, and the same panel warned that rebuilding will take time even with new leadership [6].
In our view the reviewer-seniority claim is the most testable one the panel made. Meeting rosters and review-cycle times would show whether it holds.
What to watch
- Whether the Senate votes on Heidi Overton's nomination, and whether she commits to the protection from firings the former officials urged.
- Whether the FDA or drug sponsors publish review-cycle times or meeting data that test Sharpless's junior-reviewer observation.
- Hiring figures for the rehiring the agency has already started, set against the 3,500 DOGE cuts and the larger exodus after them.
Clarity's read
What the record supports and how the coverage leans. The claims behind it follow.
Reality
- Evidence40
- Adoption
- Insufficient
- Hype gap+30
- Incentives
- Insufficient
- Confidence50
Claim ledger
Ranked by verification strength, evidence, and original report placement.
- [1]
Three former FDA chiefs, Rob Califf, Scott Gottlieb and Ned Sharpless, spoke at the STAT Summit in Boston on Wednesday and criticized former FDA officials who oversaw a staffing exodus that robbed the agency of institutional knowledge that will take years to restore.
- [2]
Rob Califf, former FDA commissioner under Presidents Obama and Biden, said at the STAT Summit: "DOGE will go down as one of the biggest disasters in American history."
- [3]
Makary resigned in May; White House official Heidi Overton has been nominated to replace him but has yet to face a Senate confirmation vote.
- [4]
Ned Sharpless called the DOGE cuts "arbitrary."
- [5]
Scott Gottlieb said at the STAT Summit: "You lost a lot of institutional memory."
- [6]
Even with new leadership, the former officials warned that rebuilding the agency will take time. They advised Overton, if confirmed, to focus not just on rehiring staff, which the agency has already started, but on reassuring officials that they will be protected from political meddling or further firings.
- [7]
All three urged the FDA to focus on its core mission; Sharpless said it is not in the FDA's mandate to change drug prices or address vaccine hesitancy.
- [8]
Califf was commissioner under Obama and Biden, Gottlieb served as commissioner for part of the first Trump administration, and Sharpless was acting commissioner toward the end of the first Trump administration.
- [9]
Sharpless said that the companies he works with as co-founder of Jupiter BioVentures often now find themselves in meetings with more junior and less experienced drug and medical device reviewers.
- [10]
The former officials said the agency may be turning a new leaf with the departures of certain high-profile officials, whom they did not name but who include Makary and two former top drug and device regulators.
- [11]
Califf said: "I think the sowers of chaos came and went."
- [12]
Gottlieb praised Kyle Diamantas, the agency's top food regulator who is now acting commissioner, and FDA policy lead Grace Graham, who he said are encouraging the agency to get "back to the basics."
- [13]
Gottlieb said: "Now we have, I think, sensible leadership that's doing smart things in the organization. I think things have gotten back to people feeling confident that the regulatory agency is making rational decisions."
- [14]
The DOGE cuts of 3,500 workers preceded a larger staff exodus under the leadership of former FDA Commissioner Marty Makary.
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Sources
1 independent publisher whose own reporting we read for this story.
- statnews.comFormer FDA officials blast DOGE as ‘one of the biggest disasters in American history’
1 article · October 14, 2026
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