Executive Summary: The group will be called the <org>Office of Therapeutic Products</org>, but needs more people to handle its increasing workload.
Growing pains and workload are taxing the <org value="ACORN:0682203466" idsrc="xmltag.org">US Food and Drug Administration's</org> cell and gene therapy staff as they prepare for increased attention from a growing sector.
A new name and reorganization may offer some relief.
<person>Wilson Bryan</person>, director of the soon-to-be former Office of Tissues and Advanced Therapies, said an influx of new people stressed managers under the old structure, with growth reaching the point where some managers were supervising more than 20 people.
"Over the last five years or 10 years, the number of INDs coming in, the number of meetings that we have, has grown at a pace that far exceeds the increases in the numbers of personnel to do that work," he said 26 September during the <org>American Society of Gene and Cell Therapy Policy Summit</org>.
The office has more than 300 employees today and is projected to grow to more than 400 in the next five years. Bryan said organizational changes will help ensure the agency's drug development advice remains consistent across divisions and offices.
"We're continuing to look at the structure of the organization, and we're continuing to think about ways to ... ensure that we're being consistent in our responses for various topics," Bryan said.
Achieving Super Office Status
OTAT will be renamed the <org>Office of Therapeutic Products</org> (OTP), and granted super office status within the <org>Center for Biologics Evaluation and Research in</org> part to deal with the problem. The FDA announced the name change and new organizational structure in a 28 September <org>Federal Register</org> notice. Both were approved 16 September, but the agency told the Pink Sheet that the new structure will go into effect in mid-February.
The new OTP organizational chart includes five gene therapy branches within the <org>Office of Gene Therapy CMC</org>. Two cell therapy branches and two tissue engineering branches also are included in the <org>Office of Cellular Therapy and Human Tissues CMC</org>.
A February reorganization split the gene therapy and cell therapy branches in two to help deal with the structural problems, Bryan said. ("CBER Reorganization Aims To Fight Recruitment Challenges Tackle Upcoming Gene Therapy Wave" "Pink Sheet" )
OTP will be the only super office within CBER. In addition to allowing for more growth, the promotion also signifies the growing importance of cell and gene therapy at the FDA. <org>The Office of Generic Drugs</org> received a similar promotion to super office status in 2013, in part to recognize the importance of the products in the US. ("FDA Generics Office Drinks Super Serum Then Shrinks" "Pink Sheet" )
Changes Will Allow Flexibility For Future Growth
Organizational changes were necessary "to better position [CBER] to address an ever-changing public health landscape." The move "creates flexibility and capacity for future growth," the FDA wrote in the notice.
"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," the agency said. "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."
The reorganization also is intended to free OTP to focus on user fee and other commitments and address growth in the Regenerative Medicine Advanced Therapy program. Bryan said reviewers and project managers in the cell and gene therapy areas already are stretched.
"We've certainly lost employees because of workload," he said.
Bryan added that his staff remains committed to supporting sponsors and bringing products forward for patients, but "we need help to do that and we need more people."
OTP likely will be one of the largest benefactors of a planned infusion of staff at CBER as part of PDUFA VII, which launched 1 October. Industry and the FDA agreed to allocate fee revenue for CBER to hire an additional 228 new employees during the five-year program cycle.
Most of the hires, 132, are planned to be added during fiscal year 2023. ("PDUFA VII Commitment Letter Outlines RealTime Review Expansion Hiring Goals" "Pink Sheet" )
An expected bolus of cell and gene therapy products in the coming years prompted industry and the FDA to increase CBER staffing. Funds also are expected to help the center modernize its IT system. ("PDUFA VII Negotiations Completed Commitment Letter Ratification Ongoing" "Pink Sheet" )
OTP's transformation does not seem as substantial as the reorganization within the <org value="ACORN:1481714709" idsrc="xmltag.org">Center for Drug Evaluation and Research's</org> <org value="ACORN:1180394355" idsrc="xmltag.org">Office of New Drugs</org>, which was completed in 2020.
OND flattened its structure into more disease-focused offices and divisions, in part to better handle its application workload and allow staff to learn more about specific diseases.
The agency also implemented the integrated assessment, where teams work together on applications from the outset rather than seek consults during the review, and centralized project management. ("Office Of New Drugs Reorg Is Bigger Than Expected US FDA Adds 11 Review Divisions" "Pink Sheet" )
The changes coincided with the emergence of the COVID-19 pandemic, but OND Director <person>Peter Stein</person> said the more focused review divisions allowed for more collaboration and a better response. ("2020 In Review US FDA New Drug Offices COVID-19 Response Aided By Reorganization" "Pink Sheet" )
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