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This article was originally published in The Gray Sheet

Executive Summary

DEVICE EVALUATION DIRECTOR ANDERSEN LEAVING FDA TO JOIN COSMETICS GROUP on April 30. FDA's Office of Device Evaluation Acting Director Alan Andersen is leaving the agency to serve as director and scientific coordinator of the Cosmetic Ingredient Review Committee, an independent panel funded by the Cosmetic, Toiletries and Fragrances Association. The committee, which is comprised of scientists and representatives from industry, FDA and CTFA, reviews and develops reports on the safety of cosmetic ingredients. Andersen told ODE staff about his plans to leave the agency on March 25. Andersen's departure provides Center for Devices and Radiological Health Director Bruce Burlington with an opportunity to hand-pick an administrator to direct efforts to revive the troubled device evaluation program. A replacement is expected to be named prior to Andersen's departure. A 22-year FDA veteran, Andersen moved to the top ODE post in April 1992 following the ouster of Robert Sheridan. The move of Andersen to the helm of ODE, which occurred in the wake of the silicone gel breast implant controversy, was seen as an indication that FDA was placing greater emphasis on scientific rigor in the device evaluation program. Andersen has an MS and a PhD in biophysics from Pennsylvania State University; Sheridan holds a BA in economics from Georgetown University. Andersen directed CDRH's office of science and technology for two years before moving to ODE and served as deputy OST director from 1986 to 1990. Between 1981 and 1986, Andersen was associate director of standards in the former Bureau of Medical Devices and deputy director of CDRH's office of standards and regulations. Andersen worked in the former Bureau of Radiological Health from 1971 to 1981. The next ODE director will face formidable challenges. ODE is under fire from industry and Congress because of the sagging level of device approvals and the mounting application backlog. Industry also is up in arms about ODE's increased emphasis on randomized trials in device applications. One of the director's first major tasks will be to respond to a report by Rep. John Dingell's (D-Mich.) Energy and Commerce oversight subcommittee. The report is expected to be highly critical of ODE and include recommendations for major changes in the device review program. Previously slated for a late March release, the report is now expected to be issued in late April.



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