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Executive Summary

The reorganization of FDA's Office of Generic Drugs includes the formation of two chemistry divisions, under acting head Robert Jerussi, PhD, out of the existing Generic Drug Division. As planned, each of the two chemistry reviewing divisions will have approximately 30 chemists as well as a number of consumer safety officers and application examiners. The target of 60 chemists in the ANDA reviewing area is more than twice the present number of reviewing chemists in the generics division. The Office of Generic Drugs staff was informed of the impending changes during an "all hands meeting" on Oct. 9. The reorganization of FDA's Office of Generic Drugs is expected to be in place when the office completes its move to new offices in the Metro Park North complex during the week of Oct. 15-19. The Office of Generic Drugs has been located in FDA's Parklawn building in Rockville, Maryland. The timing of the restructuring also coincides with the official start of Roger Williams' tenure as the new director of the Office of Generic Drugs beginning Oct. 15 ("The Pink Sheet" Sept. 10, T&G-7). FDA's reorganization plan essentially rearranges the Division of Generic Drugs and its management structure to separate management functions from technical/reviewing functions. Jerussi, deputy director of chemistry, will serve as acting director of both chemistry divisions until a second director is hired. FDA will advertise both positions. Jerussi's acting deputy director will be Thomas Poux, currently head of the ANDA Labeling Review Branch (See chart on following page). The two chemistry division heads will report directly to Office of Generic Drugs Director Williams, as will Bioequivalence Division Director Shrikant Dighe. Each of the two chemistry reviewing divisions will split the existing chemistry branches. Chemistry Division II will include the unit that handles antibiotic applications, which has been renamed Review Branch B. Although all the branches have been renamed, their staffs and functions remain the same. FDA eventually plans to add three more chemistry branches, including one training branch for new chemists. The agency said that over time the total number of branches could increase to 10. Despite FDA's recent hiring freeze due to the budget impasse, the Office of Generic Drugs has continued to recruit and hire new chemists and other staff under an exemption granted to the agency to address the increasing backlog of ANDAs and to deal with an expected influx of ANDAs resulting from 185 big-selling drugs coming off patent during the next several years. Many of the administrative functions in the Office of Generic Drugs will be placed under Generics Division Deputy Director Kent Johnson, who will assume the new title of associate director for labeling and professional support. Johnson will report directly to Williams and will be responsible for three branches: the ANDA Labeling Review Branch, which will be temporarily headed up by reviewer Yana Mille while Poux is detailed to the chemistry divisions; the Review Support Branch under Robert Pollock; and a new state and professional liaison branch with responsibility for "Orange Book" issues under Donald Hare, who formerly was a special assistant in the Office of Drug Standards. Williams' office will also have the support of a management staff consisting initially of two analysts, Shari Sheehan and Marcia Posner. They will report directly to Office of Generic Drugs Deputy Director Douglas Sporn until a director for the staff is found. An Oct. 11 memo outlining the reorganization notes that this staff will be responsible for "development of policy guides, preparation of planning and budget documents, and the conduct of analytical studies." Thomas McGinnis will continue to work as a special assistant to the office director. McGinnis came over from the Office of Drug Standards. In the future, the generics office is expected to receive the help of Edwin Dutra, who was a special assistant in the Office of Drug Standards. Dutra has been detailed to assist the newly named FDA ombudsman Amanda Pedersen. His detail will last for at least four months. Williams will also gain the assistance of Office of Research Resources Acting Director and Deputy Director Jerome Skelly, PhD. The details of Skelly's assignment as an associate director have not been yet worked out. His assignment could last for six months or longer. With Williams coming on board and the agency's recent appointment of Sporn as acting deputy director, the temporary assignments of Donald Burlington and Richard Terselic as troubleshooters in the generics office have been completed; both will return to the posts they held before the generics scandal. Burlington, the acting director of the Office of Generic Drugs, will return to his post as deputy director of the Office of Drug Evaluation II, while Terselic will resume his duties as deputy director of program management at the Office of Drug Evaluation I. Terselic will also be working on special projects for Center for Drug Evaluation and Research Director Carl Peck involving generic and new drug review issues. Speaking during the second day of the National Pharmaceutical Alliance's Oct. 9-10 technical seminar, Jerussi predicted that it will take six months to one year before FDA increases the pace of generic drug approvals. Jerussi said the rate of generic approvals will be "in hand perhaps in six months, perhaps in one year" depending on whether the reorganized staff "can deliver." The FDAer also pointed out that the rate of approvals will depend on the ease with which the agency's field inspection force is incorporated into the approval process. The field has become involved with the process through FDA's pre-approval inspection program for ANDAs and NDAs. Also, FDA has implemented a pilot program in which ANDAs are being farmed out to field chemists. However, Jerussi cautioned that FDA "will never go back" to the rate of 16 new ANDAs per month established by the former management of the Division of Generic Drugs before the investigations into improprieties in the review process. On the other hand, Jerussi suggested that FDA's previous pace of approvals was overstated by the earlier practice of dividing product ANDAs into several individual applications, one for each dosage form, strength or color. "You could divide the old numbers by two," Jerussi said. Reportedly, FDA will announce during the next two weeks a new policy for expediting the approval process of generic versions of big-selling single-source drugs. This policy will effectively establish four separate queues within the generics office: a regular ANDA queue, one for supplements, one for "minor changes" and one for blockbusters.

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