In a significant policy reversal, the Food and Drug Administration (FDA) is permitting some of its key employees to work remotely, just weeks after mandating a return to the office. This change comes in response to growing concerns about the agency's ability to function effectively following a wave of layoffs and resignations that threaten its core operations, such as the approval of new medicines. An internal email obtained by the Associated Press (AP) reveals that FDA leadership has decided to allow review staff and their supervisors to engage in telework for at least two days each week.

The agency's decision was confirmed by three FDA employees who chose to remain anonymous while discussing internal matters. This new policy was communicated to certain drug reviewers in an email sent on Tuesday, and similar messages were reportedly shared with staff involved in reviewing vaccines, biotech drugs, and medical devices, although this was not always documented in writing.

This move is seen as part of the chaotic approach adopted by the Trump administration in its efforts to reshape the federal health workforce. These actions have included not only layoffs but also a frantic effort to rehire some employees, following a substantial reduction in staff last week. Approximately 3,400 employees, or more than 15% of the FDA's workforce, were let go, including entire offices dedicated to policy and regulations, most of the agency's communications team, and key personnel supporting food inspectors and investigators. Senior officials in charge of sectors such as tobacco, new drugs, and vaccines have also been dismissed or pushed to resign.

Former FDA Commissioner Dr. David Kessler has condemned these cuts, describing them as devastating, haphazard, thoughtless, and chaotic during a recent House hearing. The fallout from these decisions has led to an alarming trend, as many lower-level employees are reportedly leaving the agency in droves.

Earlier this year, Health Secretary Robert F. Kennedy Jr. had announced intentions to eliminate 10,000 positions within the federal health workforce, claiming that FDA medical reviewers and safety inspectors would remain unaffected. However, the Department of Health and Human Services (HHS) has not provided immediate comments regarding the impact of the recent layoffs.

The cuts have raised serious concerns about the FDA's operational funding, particularly as the agency relies heavily on industry fees to sustain itself. Nearly half of the FDA's $7 billion budget is generated from fees collected from drug, device, and tobacco companies. This funding structure enables the FDA to hire thousands of employees tasked with the speedy and efficient review of new products. Notably, around 70% of the FDA's drug program is financed through user-fee agreements, which are required to be reauthorized by Congress every five years.

However, the agreements impose stipulations that if the FDA's federal funding drops below certain levels, companies are no longer obligated to pay, and in some cases, they can reclaim their contributions. These thresholds are crucial for ensuring that Congress continues to allocate funding to the FDA rather than allowing the agency to rely solely on the private sector.

The FDA and industry groups are set to commence negotiations later this year regarding the renewal of several user-fee agreements, including those related to drugs and medical devices. Michael Gaba, an attorney who provides counsel to FDA-regulated companies, emphasized the importance of reauthorizing these user fees, stating, I dont think the agency nor regulated industry can afford for user fees not to be reauthorized.

This shift towards telework, regardless of its underlying rationale, signals that the newly confirmed FDA Commissioner Marty Makary is focused on retaining and rebuilding the agency's workforce. On his first visit to the FDA headquarters last Wednesday, just one day after the mass layoffs, Makary approved the return to telework for certain employees. Steven Grossman, a former HHS official, remarked, Dr. Makary needs to rebuild teams and restart the engine of productivity lost to weeks of job insecurity, uncertainty, and shortages of team members. Turning commuting time back into work time is a great first step in achieving both.