FDA Workforce Cuts Raise Concerns Over Drug Review Timelines and Agency Morale

Recent workforce cuts at the U.S. Food and Drug Administration (FDA) have sparked alarm among industry experts and former officials, who warn of potential disruptions to drug review processes and declining morale within the agency. The unprecedented reduction in staff, coupled with controversial leadership changes, has left stakeholders anxious about the future of drug approvals and the overall functioning of the FDA.

Former FDA Officials Sound the Alarm

Scott Gottlieb, who served as FDA Commissioner from May 2017 to April 2019, and an unnamed former director of the Center for Biologics Evaluation and Research (CBER) have both expressed concerns about the impact of recent changes at the agency. The former CBER director, speaking to BMO Capital Markets analysts, cautioned that the visible changes might be "just the tip of the iceberg," suggesting that the full extent of the disruption may not yet be apparent.

The layoffs, which affected 3,500 FDA staffers, are expected to have far-reaching consequences across various departments and divisions. Both former officials anticipate potential delays in drug review timelines, with the effects likely to become more apparent in 2026 and 2027.

Potential Impact on Drug Reviews and Approvals

Despite the workforce reduction, the former CBER director believes that review teams will strive to meet typical performance goals of 10 months for standard reviews and six months for priority reviews. This commitment stems from the staff's dedication to bringing new medicines to patients. However, the official also noted that new tools might be necessary to help the reduced workforce conduct reviews more efficiently.

Gottlieb, in discussions with Leerink Partners analysts, expressed concern that the disruptions at the FDA will "diminish both the frequency and quality of interactions between the FDA and biopharma companies." This reduced communication could potentially impact the drug development and approval process.

Political Involvement and Agency Morale

The appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services has introduced an additional layer of uncertainty to the FDA's operations. Gottlieb highlighted Kennedy's influence on FDA communications and actions, citing the delayed decision on full approval of Novavax's COVID-19 vaccine as an example.

The former CBER director raised concerns about potential political involvement in the decision-making process, which could lead to increased timelines, higher evidence requirements for approvals, and a rise in refusal to file responses and complete response letters.

Adding to the agency's challenges, Kennedy's recent visit to the FDA campus, during which he reportedly accused remaining employees of being the biopharma industry's "sock puppet," has further damaged staff morale. Gottlieb described the current atmosphere at the FDA as one of "declining morale," a situation exacerbated by the unprecedented workforce cuts and controversial leadership.

Despite these challenges, both former officials offered some positive outlooks. They expect Congress to continue supporting the Prescription Drug User Fee Act (PDUFA) program, which funds nearly half of the FDA's operating budget. This ongoing financial support could help mitigate some of the negative impacts of the recent changes.

As the pharmaceutical industry grapples with these developments, stakeholders are closely monitoring the situation, hoping for minimal disruption to the critical work of bringing new medicines to patients.