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Executive Summary

FDA's Center for Biologics Evaluation and Research will include a new research division devoted to cellular and gene therapies following the center's reorganization, CBER Deputy Director Janet Woodcock, MD, told a Dec. 9 Food & Drug Law Institute meeting in Washington, D.C. Woodcock, who will head CBER's Office of Therapeutics Research and Review, described the new division as an attempt by CBER to remain "on the cutting edge" of "many very novel, very innovative types of therapies." The new division will be headed by Philip Noguchi, MD, who is currently deputy director of the Division of Biochemistry and Biophysics. While there are no currently marketed products that would have come under the purview of the division, Woodcock said, researchers will be preparing "to deal with these burgeoning new types of therapeutic approaches" once they are ready for submission. CBER has been proactive in establishing its regulatory role in the gene/cell therapy area; in January, the center's Suzanne Epstein, PhD, discussed regulatory issues surrounding those therapies at the annual "BioEast" biotech conference ("The Pink Sheet" Jan. 20, p. 11). The center plans "to implement the new organization in the next four to six weeks," CBER Director Kathryn Zoon, PhD, told FDLI. The center plans to operate under its revamped structure once it moves into its new Woodmont Office center headquarters in Rockville, Md., Zoon added. The target date for that move is Jan. 11, according to a Dec. 3 CBER memo to employees. The proposed restructuring of CBER was announced in May ("The Pink Sheet" June 1, p. 7). The proposal received HHS approval in early November ("The Pink Sheet" Nov. 9, In Brief). FDA Associate Commissioner for Management Sharon Smith Holston signed off on the division substructure of the new offices on Nov. 30. The new substructure organization was presented to the FDLI meeting by Zoon, Woodcock, Office of Blood Research and Review Director-designate Gerald Quinnan, MD and Office of Establishment Licensing and Product Surveillance Director-designate Jerome Donlon, MD/PhD. (For a complete listing of new CBER divisions and directors, see chart next page.) The "integrated research and review" structure of the reorganized center will ameliorate the expansion allowed for by the recent passage of user fee legislation, Zoon declared. CBER will receive 300 new full-time employees over the next five years as a result of the law, she said. The Center for Drug Evaluation and Research is being allocated 320 new employees. In addition to restructuring its organization, CBER has decided that the product license application review process needs to be "fairly radically altered," Woodcock said. Noting that the user fee legislation sets a six-month goal for reviews of priority applications, Woodcock outlined CBER's new "managed review" process. "We plan to have a 45-day filing meeting where a refuse-to-file or filing decision is made and where the rest of the project...will be laid out and planned, with timelines, assignments [and] dates of completion." The 45-day meeting is a concept developed by CDER last year ("The Pink Sheet" Oct. 28, 1991, T&G-1). CBER is currently preparing a refuse-to- file policy. Each PLA will "have a midpoint meeting with the senior office staff. At that meeting the outstanding obstacles will be identified as well as the progress in the review," Woodcock said. "Finally, we plan for all applications to have a recommendation of the licensing committee to the senior staff in the office, where the recommendations of the committee are reviewed and either accepted or revised by the senior management." Reviews will be coordinated by the Division of Application Review & Policy, headed by Sharon Risso, Woodcock said. DARP will contain all of the office's consumer safety officers who will be the "contact point for industry." As for specific reviewing responsibilities, "the standards by product type are going to be the responsibility of the relevant research laboratory division and staff," Woodcock said. "Regulatory standards and consistency throughout will be the responsibility of DARP. The actual review of your specific product may be done either by scientific staff within the research laboratories or within DARP on an assigned basis," she noted. The other product-oriented offices (blood and vaccines) will operate in an analogous fashion, Zoon indicated. The therapeutics office Division of Clinical Trial Design & Analysis will serve as a centerwide resource in the areas of trial design and pharmacology, Zoon said. That division will also contain CBER's oncology branch, which will be working jointly with CDER's oncology group "in order to have complete consistency in policy and standards between biologics and drugs in the cancer area," Woodcock added. The Establishment Licensing Division in Donlon's office is a new entity that will centralize the center's establishment licensing function, Donlon said. It will be headed by Susan Vargo, PhD. "This division will work with the product divisions" from the other offices, Donlon added. Also in Donlon's office, CBER has recruited a new director for the Biostatistics & Epidemiology Division: National Institute of Allergy and Infectious Diseases Division of AIDS Biostatistics Research Branch Chief Susan Ellenberg, PhD, will assume her duties "next week," Donlon announced. "In this office, we also have an advertising, promotion [and] labeling staff," Donlon said. "This is a small staff assigned to my immediate office for the purpose of coordinating the review of advertising and labeling issues within the center." CBER Associate Director for Policy Coordination and Public Affairs Mike Beatrice said in September that the center was considering creating such a staff ("The Pink Sheet" Sept. 28, T&G-7). CBER is looking into working with CDER's Division of Drug Marketing, Advertising and Communication "so that there can be a consistent...application of policy in this area as well," Donlan said. DDMAC's Bill Purvis is currently on assignment to the CBER advertising group, Donlon noted. The Office of Compliance will have only "minor modifications," Zoon said. The current Division of Congressional & Public Affairs will be moved into the center director's office, where it will be overseen by Beatrice.

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