Fairway interviewed by STAT News: How an erosion of staff threatens the FDA

Jul 07, 2025 19:56

Inside the staff exodus and tanking morale that threaten Makary’s FDA

Agency staff are already struggling, and the future consequences could be more dire

By Lizzy Lawrence, July 7, 2025

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s work, current and former employees say, and the situation could become more dire as low morale pushes more workers to the exits.

FDA employees are spooked by increasing political involvement in regulatory decisions, frustrated by the impact of cuts to administrative staff who supported drug reviews and inspections, and fed up with proclamations from the commissioner’s office that they contend rarely take career staff’s expertise into account. Three months after losing 3,500 employees — 19% of the agency’s workforce — the FDA continues to bleed talent amid a government-wide hiring freeze that has lasted almost six months.

STAT spoke with 15 employees across the agency’s drug, device, biologics, and food centers on how the FDA has functioned since the April 1 layoffs, which coincided with the start of FDA Commissioner Marty Makary’s tenure. All requested anonymity due to fear of retaliation from leadership. They told STAT that morale is incredibly low as departures mount and distrust of leaders grows among the staff that remain.

The number of employees leaving is already starting to make the work of drug and device regulation more complicated. The agency has missed a handful of review target dates. Conducting inspections in foreign countries is challenging with the loss of administrative staff who handled visa application processes. The future consequences of the winnowing of expertise could be more dire to the American public, who rely on the agency to ensure the safety and efficacy of the nation’s drugs, medical devices, food, and cosmetics.

“There are going to be situations where we don’t have the expertise on hand to review a file and so questions will not be asked,” one current agency reviewer told STAT. “In the postmarket, these issues are going to emerge.”

Makary has insisted that morale is “good and improving” at the agency, which is housed in a sprawling, 130-acre campus in Silver Spring, Md. He’s promised to give career staff the resources they need. “Commissioner Makary is dedicated to fostering a workplace culture that prioritizes the well-being, morale, and professional growth of FDA employees, recognizing that the agency’s success depends on its people,” an HHS spokesperson said.

But the relationship between Makary and his employees didn’t start off on the best foot. Makary’s boss, Robert F. Kennedy Jr., has repeatedly demonized the people working at FDA. He famously told FDA employees last October that they worked for a “corrupt system” and should “pack their bags.” In his first speech to FDA staff, he called the agency a “sock puppet” for the industries it regulates.

Compounding the antagonistic rhetoric was the Trump administration’s various efforts to get more people to leave the federal government. FDA employees feared for their jobs as the Elon Musk-led U.S. DOGE Service carried out firings of probationary workers an encouraged early retirements. The administration’s work-in-person mandate forced some employees to work in storage closets, and others to endure six-hour round-trip commutes.

Then came the mass disruption of the layoffs. With the agency in crisis, Makary softened his rhetoric and loosened some restrictions, telling employees his job is to support the and allowing reviewers to telework. HHS reversed some firings of FDA staff, including Freedom of Information Act officers, food safety scientists, and policymakers involved in user fee negotiations.

The dust has settled a bit since April 1, multiple employees told STAT. But the persistent departures of both top and mid-level staff, as well as the overruling of scientists by Makary and biologics director Vinay Prasad, have continued to deplete morale.

The mood has plummeted in the drug and biologics centers in particular. Prasad, who has also been named the agency’s chief medical and scientific officer, pushed out top gene therapy official Nicole Verdun and her deputy in June. Shortly after, drug center director Jacqueline Corrigan-Curay announced that she was retiring. Makary and Prasad bypassed career vaccine scientists to write a new Covid-19 vaccine framework in May, and Prasad overruled staff to narrow the approvals of Covid shots from Novavax and Moderna.

Then, a few weeks ago, Makary tried to push regulators to reject a rare disease drug from KalVista Pharmaceuticals after the company announced the FDA missed a review deadline due to “limited resources,” according to two sources familiar with the matter. The episode was first reported by Endpoints News. Health department spokesperson Andrew Nixon called this “totally false and untrue.”

The two employees told STAT that leadership suddenly told reviewers a few weeks ago to deny KalVista’s drug, without giving a reason. Ultimately, leaders backed down and the agency approved the drug, according to a Monday press release from Kalvista. But the incident has increased tensions and sparked anxiety about political interference in scientific reviews.

“Everything seems to happen very capriciously,” said an employee in the Center for Biologics Evaluation and Research (CBER). “There’s no sense of stability, and every time you’ve turned around someone is leaving.”

FDA morale has been challenged before, especially during the pandemic, when employees worked overtime to evaluate Covid-19 diagnostics and therapies. And career staff have been overruled before. The FDA’s top vaccine regulators resigned over former CBER director Peter Marks’ insistence to authorize Covid booster shots. Marks also overrode staff to approve a gene therapy for Duchenne muscular dystrophy.

But during Covid, there was a uniting emergency to overcome. And while Marks’ decisions were controversial, he was still very clearly a career scientist and longtime FDA employee.

Employees told STAT they wished Makary and other leaders would solicit more input before announcing major initiatives to the public. There’s little communication from Makary to staff outside of selfie video snippets he sends trying to cheer up employees. Staff have been left out of key decisions in their areas of expertise, like the development of the Covid-19 vaccine framework and a new priority review program.

The priority review program promises drug companies that “align with national priorities” a regulatory decision within one to two months after they submit their data. The criteria for drug companies that would qualify is quite vague.

Multiple drug center employees told STAT they were skeptical of the program, especially when they’re already working so hard to meet current review deadlines. A reviewer in the biologics center noted that sometimes reviews take a while because companies need time to get back to the agency. Completing a review in one or two months will require almost instant responses from companies.

“The idea that you could do a review in one to two months is totally absurd and it is dangerous because mistakes will be made,” one drug reviewer said. The agency’s current priority review pathway promises companies a review timeline of six months.

Anxiety over political interference in scientific decisions, coupled with standard workplace complaints, is making employees evaluate their career options. Leaders have not clarified when or if staff will receive end-of-year performance bonuses from 2024, which were supposed to be paid out months ago and can be as much as $5,000. And an AI chatbot named Elsa, intended to help with product reviews, is frustrating some employees. Of the 15 employees STAT spoke with, 10 are actively looking for other jobs.

As many as 600 reviewers have recused themselves from regulatory decisions due to interviewing for work with pharmaceutical companies, former FDA Commissioner Scott Gottlieb said in April. STAT’s agency sources said a high number of reviewers continue to be recused.

Leaders in charge of entire FDA centers, as well as those at the forefront of AI policy, cybersecurity, cell and gene therapies, and drug safety surveillance are gone, according to information compiled by STAT.

“I think anybody would be dumb not to be looking,” said a reviewer in the drug center. “We could be paid more in the private sector and appreciated more.”

Dan Gold, president of life sciences recruiting firm Fairway Consulting Group, said that in the past, he would receive unsolicited calls from interested FDA employees once a year. Now, he speaks to someone from the FDA or the Centers for Disease Control and Prevention every week.

The cracks from people leaving are starting to show. In addition to missing the review date for KalVista, the agency missed one for a chronic obstructive pulmonary disease drug from GSK that it ultimately approved. Three agency employees told STAT the pulmonary division is poorly staffed.

The work has not ceased as the FDA’s workforce has shrunk. It can be difficult to find officials who can formally sign product approvals or recalls, an employee in the device center said. Non-reviewer staff are stepping in to help, but the amount of work is still overwhelming.

“There’s a strong sense of community among the reviewers and the review teams, and they don’t want to let each other down,” the employee said. “But it’s definitely at the expense of their emotional, physical, and mental health.”

The lack of staff to help schedule advisory committees and provide access to medical journals has also slowed down reviews, multiple drug center sources told STAT. Reviewers have since regained access to journals, but for a few months, many had to ask companies to send PDFs of the papers they cited.

According to a recording obtained by STAT of a recent drug center town hall, scientists are also grappling with the loss of administrative staff who enabled inspections of manufacturing facilities in foreign countries. The future of the agency’s biologics and food research programs is in question, too. The contracts of many of the research fellows who staff the FDA’s labs will expire soon, which will cut research capacity.

Any organization needs experienced staff in order to function. In the case of the FDA, if the right people aren’t in the room, appropriate questions won’t be asked, and sound decisions may not be made.

For example, there is one dermatologist left in the entire medical devices center, whereas before there might be three in just one of the center’s offices, an agency source said. What happens if that person leaves, the source asked.

“It strains credulity to think that things aren’t going to fall through the cracks,” said Holly Fernandez Lynch, an associate professor of medical ethics at the University of Pennsylvania Perelman School of Medicine. “How could they not?”

Stephen Ostroff, an acting FDA commissioner during the Obama and Trump administrations, said the agency needs strong, transparent leaders to guide regulators
through the complicated process of medical product approvals. Disagreement is normal and healthy when untangling the risks and benefits of a product, but only if there’s trust.

“In those circumstances, you need seasoned veterans that have been through this process, and you need leadership who can really help guide the review staff in the decision-making process,” Ostroff said.

Companies have been quiet so far about the instability at FDA and the crisis in morale. Biotech trade association BIO told STAT that innovation requires “strong, experienced leadership” at FDA, and a purported internal document from the group says the industry will work with Makary to replace lost talent.

Fernandez Lynch noted that companies will be able to hire top agency talent to boost their regulatory expertise. But there may not be many experts left at the FDA to answer their questions.

“What a weird position I’m in as previously a critic of the FDA. Now, I’m always like, we need FDA,” Fernandez Lynch said. “We needed to tweak some things around the edges. We didn’t need to burn it all down.”

This story has been updated to include the news that the FDA approved Kalvista Pharmaceuticals’ drug.

FDA Reporter, Lizzy Lawrence, can be reached at lizzy.lawrence@statnews.com.

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