WASHINGTON (AP) In a notable policy reversal, the Food and Drug Administration (FDA) has decided to allow some of its vital employees to return to remote work. This change comes just weeks after an order to bring staff back into the office, highlighting the agency's ongoing struggle with staffing challenges following significant layoffs and resignations. These issues have raised alarms over the potential impact on fundamental functions such as the approval of new medications.

Internal communications obtained by The Associated Press reveal that FDA leadership has informed staff that review personnel and their supervisors can now resume teleworking for at least two days each week. This decision was corroborated by three FDA employees who requested anonymity to discuss sensitive internal matters.

The email, sent on a Tuesday, specifically targets some of the agency's hundreds of drug reviewers. Additionally, a similar message regarding the telework policy was relayed to teams responsible for vaccine, biotech drugs, and medical device reviews, although this was not always documented in writing.

This recent shift exemplifies the chaotic approach taken by the Trump administration in attempting to overhaul the federal health workforce. This process has included significant firings, a hurried effort to rehire some employees, and a fresh wave of layoffs last week that affected approximately 3,400 staff members, translating to over 15% of the FDAs entire workforce.

The layoffs last week targeted entire offices that focus on FDA policy and regulations, as well as a substantial portion of the agencys communications staff, alongside teams that provide support to food inspectors and investigators. Notably, senior officials overseeing critical areas, including tobacco regulation, new drug approvals, vaccines, and other essential products, have also been dismissed or coerced into resigning. This has led to an increasing number of lower-level employees choosing to leave the agency, creating further staffing challenges.

Former FDA Commissioner Dr. David Kessler characterized these cuts as devastating, haphazard, thoughtless, and chaotic during a recent House hearing, emphasizing the detrimental impact it could have on public health.

Health Secretary Robert F. Kennedy Jr. had previously announced plans to eliminate 10,000 positions across the federal health workforce, assuring that medical reviewers and safety inspectors at the FDA would remain unaffected. However, the Department of Health and Human Services (HHS) did not respond promptly to a request for comment following these layoffs.

In February, HHS had to bring back some probationary employees who were terminated, including hundreds of medical reviewers at the FDA. These reviewers are primarily funded through industry fees rather than direct federal allocations, underscoring the agency's reliance on external funding.

The implications of the recent layoffs, combined with ongoing resignations and retirements, have raised significant concerns about the sustainability of FDA funding. The agency, which operates on a budget of $7 billion, receives nearly half of its funding through fees collected from pharmaceutical, medical device, and tobacco companies. This funding model allows the FDA to employ thousands of personnel tasked with efficiently reviewing new products.

For instance, around 70% of the FDAs drug review program is financed through user-fee agreements that must be reauthorized by Congress every five years. However, the agreements come with stipulations: if federal funding for the FDA dips below certain thresholds, companies are no longer obligated to pay those fees and may even reclaim previously paid funds. This framework is intended to ensure that Congress maintains adequate funding for the FDA, rather than leaving it entirely dependent on the private sector.

Later this year, the FDA and industry stakeholders are expected to enter negotiations to renew multiple user-fee agreements for drugs and medical devices. Michael Gaba, an attorney who advises companies regulated by the FDA, emphasized the necessity of reauthorizing these user fees, stating that neither the agency nor the regulated industries can afford it not to happen.

Despite the motives behind the recent shift back to telework, former federal officials have noted that it may signal an effort by the newly confirmed FDA Commissioner Marty Makary to stabilize and rebuild agency staffing. Dr. Makary made his first appearance at the FDAs headquarters just a day after the mass layoffs, emphasizing the urgency of his task.

Steve Grossman, a former official at HHS, commented on the situation, saying, 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.

In summary, the FDA's decision to allow remote work for select employees reflects the agency's attempts to adapt amidst a tumultuous period marked by significant staffing changes. The outcome of upcoming negotiations regarding user-fee agreements will be crucial in determining the FDA's operational capabilities in the near future.

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institutes Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.