FDA elevates OTAT to “Super Office” within CBER

Regulatory NewsRegulatory News | 30 September 2022 |  By 

FDA's Wilson Bryan at ASGCT

The US Food and Drug Administration (FDA) announced this week it has elevated and reorganized its Office of Tissues and Advanced Therapies (OTAT) to a “Super Office” within the Center of Biologics Research and Evaluation (CBER) to meet its growing workload and new commitments under the Prescription Drug User Fee Act (PDUFA VII) agreement for FY2023-2027.
 
The office will be renamed the Office of Therapeutic Products (OTP).
 
“With the current and anticipated increase in workloads, the proposed structural changes will improve functional alignment, increase review capabilities, and enhance expertise on new cell and gene therapies. Additional supervisory positions will not only help to address this increased workload but will also provide advancement opportunities to facilitate recruitment and retention of highly qualified staff,” FDA announced in a 28 September notice.
 
The move “creates flexibility and capacity for future growth in Full-Time Employees (FTEs) and workload, avoiding the need for continual reorganizations. The reorganization will position OTP to focus on commitments, including those negotiated with industry in the prescription drug user fee agreement (PDUFA) for FY 2023-2027, and other key priorities that protect public health,” FDA said.
 
Wilson Bryan director of FDA’s Office of Tissues and Advanced Therapies (OTAT) described the current staffing challenges and the impact of PDUFA VII resources on hiring at the 26 September meeting of the American Society of Gene and Cell Therapy (ASGCT).
 
He said OTAT reviewers are “really, really stretched,” and added that “over the last five to ten years, the number of INDs coming in and the number of meetings has grown at a pace that far exceeds increase in the number of personnel to do that work. This creates a very stressful situation.”
 
Bryan said that OTAT now has a staff of 300 employees, and with additional funding under PDUFA VII, should be able to hire 100 reviewers over the next five years.
 
Bryan also wants to tamp down expectations that these new hires will be immediately available to review applications, noting that it may take years to train these employees before they are ready to review applications.
 
While the additional funding will help with hiring, he said that one lingering challenge is the inability to retain seasoned employees because of the higher-paying jobs offered in the private sector; this also affects the agency’s ability to attract new talent.
 
“We lose a lot of people who are interested because our salaries are not competitive. We have lost some really good people because they can go someplace else and make a lot more money,” he said. He added that in one year, the office lost five to six people who had 20 years or more of experience. “I am not losing decades of experience; I am losing centuries of experience and it takes a while to rebuild that.”
 
FDA notice
 
ASGCT meeting
 
 

 

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Tags: and, cell, FDA, gene, OTAT, therapy

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