Former FDA Chiefs Say DOGE Cuts Still Hit Drug Reviews

Three former FDA commissioners said on Oct. 14 that Elon Musk’s 3,500 DOGE cuts stripped the agency of people who knew how reviews work. Robert Califf, who ran the FDA under Presidents Obama and Biden, called DOGE “one of the biggest disasters in American history.”

Scott Gottlieb and Ned Sharpless, both former chiefs from the first Trump term, said the harm now shows up in meetings. Drug and device companies sit with junior reviewers, and they said rebuilding will take years.

Three Former FDA Chiefs Call the Cuts a Historic Disaster

The panel in Boston went straight at the April 2025 layoffs run through Musk’s U.S. DOGE Service. Califf did not hedge. Sharpless called the cuts “arbitrary.” Gottlieb’s line was shorter and colder.

“You lost a lot of institutional memory,” Gottlieb said.

DOGE will go down as one of the biggest disasters in American history

Robert Califf, former FDA commissioner, speaking in Boston on Oct. 14, 2026

They also said the loudest period of turmoil at the top has eased. They did not name the officials they had in mind. The recent departures include former Commissioner Marty Makary, former biologics chief Vinay Prasad, and former acting drug-center head Tracy Beth Høeg.

“I think the sowers of chaos came and went,” Califf said. Gottlieb praised Kyle Diamantas, who now runs the agency on an acting basis, and Grace Graham, the policy chief, for pushing the place “back to the basics.”

“Now we have, I think, sensible leadership that’s doing smart things in the organization,” Gottlieb said. “I think things have gotten back to people feeling confident that the regulatory agency is making rational decisions.”

Both Drug Centers Are Still Short of 2025 Staff

The headcount story is not only the April 2025 round. federal workforce changes data set figures covering September 2024 through January 2026 show the FDA lost about 21% of its people, more than 4,400 in all, a wider slide than the DOGE cut alone.

The drug and biologics centers put names and dates on that slide. The agency’s own quarterly net hiring tables for CDER and CBER track who came and who left.

CDER AND CBER HEADCOUNT

CDER’s worst quarter was the one that ended Sept. 30, 2025, a net loss of 740 people, months after the April firings. That is the “larger staff exodus” the former chiefs tied to Makary’s tenure, written in the agency’s own ledger.

Hiring is underway and still thin. Lowell Zeta, then acting chief of staff, told the BIO International Convention in June 2026 that the agency would “bring back 2,200, to start,” and that some who left could come back. Karim Mikhail, who directs the biologics center, told drugmakers in September, “We’re very actively hiring.”

The rebuild has not yet flipped the trend for long. After five straight quarters of net losses, CDER posted a net gain of 26 people in the quarter that ended June 30, 2026, with 101 hires and 75 departures, and stood at 4,895. CBER stood at 1,095 that day and was still down for the quarter.

Sponsors Now Meet Junior Reviewers at the Table

Sharpless now co-founds Jupiter BioVentures. He said the companies he works with often find themselves in meetings with more junior, less experienced drug and device reviewers. That is the part of the disaster you cannot see on a headcount chart.

An early 2026 look at new-drug review clocks found they mostly held after the 2025 cuts, which fits an older point from that year: many scientists who directly review new medicines were spared the first wave. The scoreboard can still look fine while the people across the table change.

At the device center, staff first learned they were fired when their badges stopped working, former deputy inspectorate director Rhonda Mecl said, and some notices had the wrong office or the wrong performance scores. People were told to take their computers home at night. “It was a horrendous era,” Mecl said.

Sean Boyd, who spent more than 30 years at the device center and had planned to retire from the Public Health Service and return as a civilian, said his return offer was pulled in a February 2025 hiring freeze. He said institutional memory and culture at CDRH have been “severely diminished,” and that people are “just focused on getting done what they must get done.”

What Device Companies Are Seeing in Real Files

The Center for Devices and Radiological Health authorized 124 new devices in 2025, on par with 2024, and it issued 59 warning letters and posted 110 recall communications, more than the year before. The work did not stop. The files got messier, according to lawyers who sit in those meetings, and that is what sponsors are carrying into 2026.

WHAT SPONSORS ARE HITTING

• Mid-file reversals: Son Nguyen, special counsel at Cooley and a former FDA staffer, said new reviewers have come onto pending premarket files and taken a more conservative line than the people they replaced.
• Conflicting Q-subs: Jason Brooke, an attorney at Brooke & Associates, said pre-submission meetings are less useful because advice on items such as AI performance targets has changed a year later, which can burn development time.
• Thinner letters: Philip Desjardins, a partner at Arnold & Porter, said 510(k) deficiency letters have carried less detail, so companies are told something is wrong without enough to fix it.
• Late labeling asks: Kelliann Payne, a Hogan Lovells partner, said she has seen feedback as late as two days before a clearance, when a sponsor has little choice but to take the change or miss the date.

Payne has been writing premarket submissions since the late 1990s. She called this stretch the most volatile timing she has seen. Mecl said investigators are taking on more hours to keep inspections up, and that only three of the original eight medical-products directors and deputies remained in that inspections shop when she described it. Output held. The bench underneath it did not.

Makary, Prasad, and Høeg Are Out

The former chiefs treated the recent exits as a chance to reset, not as proof the agency is whole. The sequence is short and ugly.

THE LEADERSHIP TURNOVER

1. April 2025: DOGE cuts 3,500 FDA workers and sets off a wider staff drain.
2. April 2026: Vinay Prasad leaves the biologics center at the end of the month, his second exit in less than a year.
3. May 12, 2026: Marty Makary resigns as commissioner after a fight that included flavored vaping products.
4. May 2026: Tracy Beth Høeg, acting head of the drug center, is fired after she refuses to resign; she said she had been in the job six months.
5. September 2026: Michael Davis and Karim Mikhail are named permanent directors of the drug and biologics centers.
6. Oct. 14, 2026: Califf, Gottlieb, and Sharpless tell a Boston audience that the cutters left a years-long hole.

Gottlieb’s bet is that the people now in the building are calmer. Diamantas, listed by the FDA as acting commissioner of food and drugs, came up through the Human Foods Program. Graham is deputy commissioner for policy, legislation, and international affairs, a Hill veteran on user-fee bills. On the same day as the Boston panel, Gottlieb wrote that a new FDA push on rare-disease reviews was a meaningful step on rare diseases and would help speed new policy.

Policy can look steadier while the review bench is still young. That is the gap the former chiefs were describing.

No Senate Vote Yet on Heidi Overton

White House papers show Overton’s nomination sent to the Senate on Sept. 14, 2026. Heidi Overton is a physician and a White House domestic policy aide from New Mexico. She testified at a Senate hearing in September. As of the Boston panel, she still had not had a confirmation vote.

The former chiefs said the next commissioner, if the Senate confirms one, cannot stop at posting jobs. The agency has already started to hire. They said the harder task is convincing people that they will not be yanked around or fired again for politics.

Recruit, support, and defend the workforce. That will bring them back.

Scott Gottlieb, former FDA commissioner, speaking in Boston on Oct. 14, 2026

Gottlieb put those three verbs in order on purpose. Recruiting without defense just refills a leaking bucket. Defense without recruiting leaves the junior people Sharpless keeps meeting. Overton, if she gets the job, inherits both problems at once, plus a workforce that has already watched one round of badges die overnight.

High Drug Prices Feed the Distrust, Califf Warns

The panel did not leave the rest of Health and Human Services off the table. Califf said Secretary Robert F. Kennedy Jr. “is just actively still eroding public confidence” on vaccines, and that it will be hard to repair “until he’s moved on to some other job.” In 2025, while Makary was still commissioner, the FDA added safety warnings to mRNA Covid-19 vaccines about a rare heart-inflammation side effect. Gottlieb said his own criticism of Kennedy, dating to the nomination, led him to hire extra personal security.

Califf also refused to hang the whole trust problem on Kennedy. He said Americans are angry about what care costs, and that industry never says so out loud.

“If I would just get one biotech exec to say you know what, our drugs are too expensive,” Califf said. “You just never hear that and you know you wonder why people are upset and going to other sources of information.”

Sharpless pulled the agency back to a narrower job. It is not the FDA’s mandate, he said, to cut drug prices or to fix vaccine hesitancy. The statute is safe and effective medicine.

“And if it sticks to its sort of statutory role, it’ll be fine,” he said.

Sticking to that role still takes people who have seen a file before. Diamantas can talk about basics, Graham can work the Hill, and Overton can wait on a vote. The companies Sharpless backs will keep walking into rooms where the reviewer is new, the letter is thin, and the last person who knew the product is gone.