Former FDA officials blast DOGE as ‘one of the biggest disasters in American history’

DOGE was an Elon Musk-led initiative that conducted mass layoffs of government employees. At the FDA, its cuts mattered because they removed people who carried years of knowledge about medicines, devices, procedures, and agency decisions.

The initiative cut 3,500 FDA workers. Former commissioners said those reductions came before an even larger staff exodus during Marty Makary’s turbulent leadership. That combination left the agency with fewer experienced reviewers and less institutional memory.

The former officials called the cuts arbitrary and warned that rebuilding will take years. The FDA has begun rehiring, but a future commissioner must also reassure employees that political interference and additional firings will not threaten their jobs. Their advice was simple: recruit, support, and defend the workforce.

The article identifies two waves of staffing loss at the FDA. First came DOGE’s cuts, which removed 3,500 workers. Then came a larger staff exodus during the tumultuous leadership of former Commissioner Marty Makary.

The key scale point is that 3,500 is only the documented DOGE reduction, not the total decline. The article does not provide a number for the subsequent exodus. Former officials described the combined effect as a major loss of institutional knowledge and experience.

That missing total makes the full size of the disruption difficult to measure from the available information. Still, the consequences are clear: companies now sometimes meet more junior reviewers, and rebuilding will take years. The FDA has started rehiring, but retention and trust are also essential to restoring capacity.

Experienced FDA employees carry institutional memory: knowledge of past decisions, scientific standards, review practices, and how complex issues were handled. Losing that experience can make reviews slower, less consistent, and harder to navigate for both regulators and companies.

Ned Sharpless said companies connected to Jupiter BioVentures often now meet more junior and less experienced drug and medical device reviewers. Scott Gottlieb summarized the problem by saying, “You lost a lot of institutional memory.” The mechanism is practical: fewer seasoned reviewers means fewer people who can apply judgment built through previous cases.

The former officials warned that this knowledge will take years to restore. Rehiring helps, but rebuilding expertise requires support, training, and stable leadership. Until then, the FDA may face weaker continuity in decisions involving medicine and device safety and effectiveness.

The article describes the FDA’s core legal responsibility as working within its statute to prioritize safe and effective medicine. That means the agency should concentrate on evaluating health products and monitoring safety, rather than trying to solve every public-health or economic problem.

Its public-protection role includes reviewing whether medicines are safe and effective and, when needed, using post-market surveillance. The article gives a vaccine example: the FDA added safety warnings to mRNA Covid-19 vaccines about a rare heart-inflammation side effect. That shows how regulatory information can alert patients and clinicians to identified risks.

Former acting Commissioner Ned Sharpless said the FDA is not mandated to change drug prices or address vaccine hesitancy. He argued that staying within its statutory role would help the agency function properly. A focused mission can also make decisions clearer and strengthen public confidence.

Scientific regulators need confidence that evidence, not political pressure, will guide their work. If employees fear dismissal or interference, they may leave, avoid difficult decisions, or hesitate to speak openly about safety and effectiveness concerns.

The former officials therefore told any incoming commissioner to do more than rehire staff. They urged leadership to reassure employees that they will be protected from political meddling and further firings. Gottlieb’s prescription was, “Recruit, support, and defend the workforce.” Without that protection, hiring alone may not restore capacity because experienced people may not return.

The article reports some optimism under acting Commissioner Kyle Diamantas and policy lead Grace Graham, whom Gottlieb said were encouraging a return to basics. Still, rebuilding trust will take time. Stable leadership and defensible decisions could help restore recruitment, retention, and confidence in the FDA’s work.

Public trust is cumulative, but it can be damaged quickly by confusing, politicized, or contradictory health messages. Leadership changes do not automatically erase what people remember, especially when those messages shaped personal decisions about vaccines.

Ned Sharpless pointed to federal communication errors during the pandemic and said politicizing a vaccine damaged confidence. Califf and Gottlieb also criticized Health Secretary Robert F. Kennedy Jr., saying his vaccine views and policy changes continue to erode public confidence. These examples show how both past mistakes and current messages can reinforce skepticism.

The effects can persist even after officials leave because people may continue doubting federal health agencies. The former leaders advised the FDA to focus on its statutory mission and make rational decisions. Clear, consistent communication from credible institutions would be necessary to rebuild trust, though the article does not promise a quick recovery.

The article states that the FDA’s core mission is to prioritize safe and effective medicine. In practice, this means examining scientific evidence before authorization and continuing to watch for important risks afterward. The article does not detail every review step, so this explanation uses established FDA practice.

Generally, reviewers assess clinical-study results, known benefits and risks, manufacturing information, and other evidence. After a product reaches patients, post-market surveillance can identify uncommon or longer-term problems. The article cites renewed reviews of vaccine safety and efficacy and the addition of warnings about rare heart inflammation linked to mRNA Covid-19 vaccines.

This process matters because patients need reliable information about benefits and risks, while companies need consistent rules for developing products. The former officials said the FDA should stay focused on that statutory role. Clear, evidence-based reviews can protect the public and support confidence in regulatory decisions.