FDA creates advanced therapies ‘super office’ to meet higher demand

The US FDA office tasked with overseeing cell and gene therapies has been renamed and reorganized in response to increased submissions.

The changes – details of which were published in the Federal Register last week – saw the ‘Office of Tissues and Advanced Therapies’ become the ‘Office of Therapeutic Products (OTP)’ and will be designated as a ‘super office’ that will manage its program at a macro level.

The changes – which came into effect on September 16 – will help the office better cope with increased demand according to the Center for Biologics Evaluation and Research (CBER).

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“With substantial growth in innovative, novel products, as well as a need to address an ever-changing landscape of potential public health threats, CBER is currently facing scientific, medical, and regulatory challenges that require changes to its structure.”

It added that “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.”

In addition, to helping the office cope with a higher workload, the CBER predicted that the new structure will provide current staff with “advancement opportunities to facilitate recruitment and retention of highly qualified staff.”

The CBER also said the new structure creates flexibility and capacity for future growth and will avoid 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.”

The news is in keeping with comments made by OTAT director Wilson Bryan who told delegates at the American Society of Gene and Cell Therapy’s policy summit this week that staff retention has been a challenge according to one report.