According to an internal email, the agency may be in for more consolidation in areas including human resources, communications, travel and acquisitions.
FDA Commissioner Marty Makary is considering further consolidations at the agency—though without affecting groups that conduct inspections and review applications, according to a Friday report from Endpoints News.
In an email sent last Wednesday to FDA employees, Makary suggested that the agency will put human resources, acquisitions, travel, disclosures, communications, facilities, budget and IT operations under a “unified approach.” The goal, according to the email, is to “eliminate duplicative services, increase cross-communications across the FDA and deliver more consistent, efficient and responsive support” for its review teams.
It remains unclear if this move will mean additional layoffs and, if so, how many employees will be affected.
The impending changes, which haven’t been finalized yet, come as the FDA in recent months has struggled to deliver timely decisions on drug applications. Most recently, the regulator on Friday told KalVista Pharmaceuticals that it would not be able to release a verdict in time for its PDUFA target for the company’s oral drug candidate for hereditary angioedema.
According to the biotech’s release, the delay is due to “heavy workload and limited resources” at the FDA. The decision is now expected “within approximately four weeks,” the FDA told KalVista.
The FDA has already missed target decision dates for Novavax’s next-generation COVID-19 vaccine, GSK’s chronic obstructive pulmonary disease expansion for Nucala and Stealth BioTherapeutics’ Barth Syndrome treatment.
In March, Health and Human Services Secretary Robert F. Kennedy Jr. enacted a massive overhaul of the department, including 10,000 layoffs across its various units. The FDA took a heavy blow, losing around 3,500 staff, though Kennedy’s office has insisted that fired employees were not directly involved in product reviews.
However, Genevieve Kanter, associate professor of public policy at the University of Southern California Price School of Public Policy, told BioSpace in April that the matter is hardly that simple.
“The idea that FDA reviews won’t be adversely affected after such a draconian staffing cut is like firing all the staff at a clinic and saying that patient care won’t be affected because we haven’t fired the doctors,” she said.
