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FDA GENERIC DRUG DIVISION GAINING 14 FTEs FROM NEW DRUG GROUPS

Executive Summary

FDA GENERIC DRUG DIVISION GAINING 14 FTEs FROM NEW DRUG GROUPS to help temporarily with the backlog of ANDAs that have accumulated since the beginning of the generic investigation. The personnel from the Offices of Drug Evaluation I and II include up to 21 Consumer Safety Officers, chemists, microbiologists and application examiners. Staff began moving over to the Generic Drugs Division the week of April 23. The directors of the Offices of Drug Evaluation I and II were notified in an April 12 memo from Center for Drug Evaluation and Research Director Carl Peck, MD, that they would be donating the services of certain of their NDA review staff to the Division of Generic Drugs for three to six months. The agency plans to recruit permanent replacements for the 14 FTEs within six months. The division hopes that the additional manpower will help pick up the pace of approvals and other action letters. Rep. Dingell (D-Mich.) recently threatened hearings for this summer if FDA doesn't show "significant improvement" in approvals ("The Pink Sheet" April 16, p. 5). To date there have been four ANDA approvals in January, one in February, seven in March, and none in April. Four CSOs (3 FTEs) have already joined the generics staff: Robert West, from the Medical Imaging, Surgical & Dental Drugs Division, will work with ANDA Review Branch I; Dorothy Pease and James Hannan, both from the Pilot Drug Evaluation group, will share duties in ANDA Review Branch III; and Division of Metabolism and Endocrine Drug Products CSO Rita Hassall will be in charge of CSO activities in ANDA Review Branch II. One more CSO may be added later, FDA said. Eight chemists (5 FTEs) from other divisions will devote time to ANDAs, two full-time and six part-time. One supervisory chemist (1 FTE) will assume a full-time position in the division. The Division of Anti-Infective Drug Products is donating four part-time microbiologists (1 FTE). In addition, the generic division is gaining three application examiners (3 FTEs) who will assess incoming applications for completeness and refuse to file them if the information is inadequate. CDER is currently working on a policy for standardizing ANDA submissions. Over the last few months, the agency has been actively recruiting new staff for the division. The group was allotted an additional 30 FTEs for fiscal year 1990 and recently added another ANDA Review Branch to assist in reducing the backlog of ANDAs ("The Pink Sheet" April 2, T&G-12). In addition to the 14 FTEs from new drug divisions, the division will have to replace two current employees, one who is retiring and another who has asked to be relocated in the agency.
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