FDA Cuts Threaten New Drugs as Reviewers Saddled With Extra Jobs

HHS Secretary Robert F. Kennedy Jr.’s sweeping layoffs across federal health agencies are disrupting the work of drug, medical device, and food reviewers, forcing employees to pick up additional duties after administrative and support staff were culled from their jobs.

It’s been two weeks since the US Department of Health and Human Services carried out its large-scale reduction-in-force as part of the Trump administration’s efforts to drastically shrink the size of the government. The cuts targeted 3,500 employees at the Food and Drug Administration, or almost 20% of the agency.

The layoffs largely spared drug, medical device, and food reviewers and inspectors, but those employees are now finding it difficult to complete crucial tasks and meet review goals after the agency fired staff that provided critical support for them. The reductions broadly hit staff working in program management, human resources, technology, policy, communications, and several top leaders with years of institutional knowledge.

“Our jobs have become exponentially harder,” said one device reviewer who asked to remain anonymous to protect against retaliation from the administration. “At a minimum, innovation is slowed, which may result in less access to life-saving devices and treatments. This impacts the industry bottom line, but more importantly grinds medical advancement to a halt.”

Reviewers at the FDA go through a rigorous process to evaluate the safety, effectiveness, and quality of drugs and devices before they can be approved. Inspectors also play a critical role by ensuring that manufacturers comply with regulations.

Another reviewer said in an interview that it’s “no longer hypothetical” that drug reviews will slow. The reviewer said they expect to miss a date required under the Prescription Drug User Fee Act because their leadership and those who sign off on approvals was pushed out. That act allows the FDA to collect sizable fees from industry so that they can complete reviews in a timely manner.

New FDA commissioner Marty Makary in an all-hands meeting April 11 said little about the layoffs, but noted the recent changes “have been aimed at consolidating, being more efficient and creating more teamwork,” according to a transcript obtained by Bloomberg Law.

The former Johns Hopkins surgeon said he wanted to ensure the scientists, reviewers, and inspectors “have all the resources” they need to do their job. That aim appeared to clash with concerns from current and former employees who heavily relied on the fired staff to help complete their duties.

“Even if product reviewers are not terminated, other FDA staff are critical facilitators of product review work,” said Eva Temkin, a former FDA acting policy director in the Center for Drug Evaluation and Research (CDER).

“These kinds of broad swath terminations will result in missed user fee goals and commitments,” said Temkin, who’s now a partner at Arnold & Porter Kaye Scholer LLP. “It can also undermine industry’s ability to plan product development in the US—ultimately risking continued innovation and timely patient access to treatments.”

Some industry groups expressed concerns when the layoffs hit. The Association for Accessible Medicines worried about key officials fired within the generic drug and biosimilar programs. The Pharmaceutical Research and Manufacturers of America said the changes raised “questions about the agency’s ability to fulfill its mission.”

Research, Technology

Among the challenges reviewers now face is difficulty accessing medical and scientific articles after the FDA fired library staff. Those employees helped reviewers get access to subscriptions and journals that would support data for drug or device approvals.

“We may not be able to access the information we need to complete a review efficiently and effectively,” said a device reviewer. “We cannot solely rely on literature provided by an applicant; we must do our own background research to evaluate studies used as supporting data for drug and device approvals.”

This move will likely increase the number of interactions needed before approving a clinical study, said another device reviewer.

The FDA also cut back its policy staff, making it tough for reviewers to consult with other experts about technical topics related to approval and inspection functions. Among the policy divisions axed was the Office of Generic Drugs, according to Martha Nguyen, who was the director of policy in that department.

Various reviewers are also struggling with the elimination of information technology staff, who helped the agency with tech issues, cybersecurity, and broken devices.

The team notably helped enhanced the agency’s ability to manage and analyze critical data, according to a letter sent to staff from the FDA’s chief information officer, Vid Desai, who was also lost his job.

“The reality is that nothing within the FDA operates without IT and data,” Desai wrote in a Linkedin post. “The recent decimation of IT teams will inevitably cause substantial disruptions across FDA operations.”

Travel, Communications

Layoffs at the agency’s travel office also are taking a toll on inspectors, who now have to spend more time processing their own travel plans.

The travel division held a wide range of responsibilities, including handling visas, travel vouchers, paperwork, booking flights, and appointing translators.

“FDA found that it needed people to do travel planning,” said Howard Sklamberg, a former director of compliance at CDER.

“They’ve hired more people to do foreign inspections, and sometimes it’s challenging to do because you’re spending sometimes half of your time traveling to not very glamorous places,” said Sklamberg, who’s now a partner at Arnold & Porter. “Those people are supported by an infrastructure.”

Other reviewers say the loss of communications staff makes it difficult for them to share information about products with the public. The agency cleared offices of drugs, medical devices, biologics, veterinary medicine, and food, which all worked to to ensure that timely and accurate health information was shared with the public.

“When we complete a review there was a lot of work done by communications folks who made sure that our reviews were accessible to the public,” said one food safety reviewer. “Now all of that stuff is delayed.”