FDA CDER DEPUTY DIRECTOR FOR REVIEW MANAGEMENT IS MURRAY LUMPKIN, MD

FDA CDER DEPUTY DIRECTOR FOR REVIEW MANAGEMENT IS MURRAY LUMPKIN, MD, formerly director of the Center for Drug Evaluation and Research's anti-infective drugs division. Office of Generic Drugs Director Roger Williams, MD, will assume the duties of CDER Associate Director for Science and Medical Affairs. Both FDAers will take over their new positions on Aug. 2. CDER Director Carl Peck announced the appointments in a July 21 memo informing center staff of his recommendations to the commissioner for candidates to fill the two newly created deputy slots at CDER. Peck noted in the memo that "the new center positions were established to accomplish functions formerly performed by D. Bruce Burlington, MD, and to help ensure a smooth transition when [CDER Deputy Director Gerald] Meyer and I retire from federal service in the coming months." Peck, 51, will retire on Nov. 1 after 26 years in government service ("The Tan Sheet" May 24, p. 9). Meyer, 57, plans to leave FDA in January after 20 years with the agency ("The Tan Sheet" May 10, In Brief). FDA Deputy Commissioner Jane Henney has convened a 14-member search committee that is to forward a short-list of candidates for the center director position by November ("The Tan Sheet" July 12, p. 11). In his new post, the memo states, Lumpkin "will provide leadership to functional areas relative to the new drug review process, including the implementation of user fees and efforts to accomplish the goals agreed to as a part of this legislation." Williams will be responsible "for assuring implementation of other Agency initiatives and the resolution of scientific and medical issues." Lumpkin and Williams have been groomed for the positions since Burlington left CDER in February to become director of the Center for Devices and Radiological Health. Since then, the anti-infectives division director has assumed Burlington's responsibilities for user fee implementation and was instrumental in developing a series of guidances that were sent out with user fee invoices the week of July 19 (see preceding story). Williams took the lead on developing FDA's regulatory stance on stability and impurities issues regarding the International Conference on Harmonization draft guidelines. In addition to user fee implementation, Lumpkin will have purview over the Recruitment Crisis Task Force, formed to assess CDER staffing needs ("The Tan Sheet" June 14, p. 14) and the allocation of resource needs by discipline and across new drug offices and divisions. Lumpkin will also oversee joint reviews with other countries and product labeling format revisions to make labeling more physician- and consumer-friendly. As associate director for science and medical affairs, Williams will be responsible for the center's research resources activities and the application of resources to the resolution of scientific and medical issues affecting application review. The associate director also will be in charge of resolution of issues, problems, complaints, and appeals regarding generic and OTC drug reviews. Williams will oversee the MedWatch adverse reaction reporting system and international harmonization activities. Williams and Lumpkin will share responsibility for policy development, product jurisdiction issues, clinical holds, and refuse-to-file decisions. Lumpkin, 39, joined the agency from Abbott in December 1989 as director of the anti-infective drugs division after former division director Edward Tabor left for the National Cancer Institute. At Abbott, Lumpkin was director of international clinical research. Prior to his stint with the company, Lumpkin spent three years as chief of pediatric infectious diseases and assistant medical director of East Tennessee Children's Hospital. He received his medical degree from Wake Forest University. Williams, 52, was recruited by FDA from the biopharmaceutical R&D firm Genelabs in July 1990 to head the beleaguered Office of Generic Drugs in the wake of the generic drugs scandal. Williams served as medical director for Genelabs less than a year. He was director of the University of California at San Francisco School of Pharmacy drug studies unit prior to joining the Redwood City, Calif.-based firm. Williams received his medical degree from the University of Chicago. OGD Deputy Director Douglas Sporn will serve as acting director of the generic drugs office; however, Williams will "continue to provide scientific and medical oversight." All CDER senior executive staff medical officers were invited to apply for the deputy positions. FDAers, in addition to Lumpkin and Williams, who were understood to have responded and been interviewed for the positions include: Office of OTC Drug Evaluation Director Michael Weintraub, MD ("The Tan Sheet" June 28, In Brief); Office of Drug Evaluation I Director Robert Temple, MD; and Oncology and Pulmonary Drug Products Division Director Gregory Burke, MD.