FDA Faces Further Consolidation as Delays Continue to Plague Drug Reviews

The U.S. Food and Drug Administration (FDA) is considering additional consolidation measures amid ongoing delays in drug application reviews, according to an internal email from FDA Commissioner Marty Makary. This move comes on the heels of recent layoffs and organizational changes that have already impacted the agency's operations.

Proposed Consolidation and Its Implications

Commissioner Makary's email, sent last Wednesday to FDA employees, outlined plans to unify several administrative functions under a "unified approach." These areas include human resources, acquisitions, travel, disclosures, communications, facilities, budget, and IT operations. The stated goal is to "eliminate duplicative services, increase cross-communications across the FDA and deliver more consistent, efficient and responsive support" for review teams.

While the email suggests that groups conducting inspections and reviewing applications will not be affected, the extent of potential layoffs remains unclear. This uncertainty adds to concerns about the FDA's ability to manage its workload effectively.

Recent Delays in Drug Application Reviews

The FDA's struggles with timely decision-making on drug applications have become increasingly apparent in recent months. Notable examples include:

1. KalVista Pharmaceuticals: The FDA informed the company that it would miss the PDUFA target date for its oral drug candidate for hereditary angioedema. The delay was attributed to "heavy workload and limited resources," with a decision now expected in approximately four weeks.

2. Novavax: The agency missed the target decision date for the company's next-generation COVID-19 vaccine.

3. GSK: A delay occurred in the review of the chronic obstructive pulmonary disease expansion for Nucala.

4. Stealth BioTherapeutics: The FDA missed the target date for the company's Barth Syndrome treatment.

Impact of Recent HHS Overhaul

The FDA's current challenges are compounded by the recent overhaul of the Department of Health and Human Services (HHS) initiated by Secretary Robert F. Kennedy Jr. in March. This restructuring resulted in 10,000 layoffs across various HHS units, with the FDA losing approximately 3,500 staff members.

While Kennedy's office has maintained that the fired employees were not directly involved in product reviews, experts have questioned this assertion. Genevieve Kanter, associate professor of public policy at the University of Southern California Price School of Public Policy, likened the situation to "firing all the staff at a clinic and saying that patient care won't be affected because we haven't fired the doctors."

As the FDA grapples with these organizational changes and resource constraints, the pharmaceutical industry and patients alike are left to navigate an increasingly uncertain regulatory landscape. The coming weeks and months will likely reveal the full impact of these developments on drug approvals and public health initiatives.