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This article was originally published in The Gray Sheet

Executive Summary

FDA DEVICE CENTER DIRECTOR BRUCE BURLINGTON, MD, is bringing a track record as a new product review specialist and managerial trouble shooter within the agency to his new job as head of the Center for Devices and Radiological Health. Burlington will assume leadership of the device center on Feb. 22; FDA Commissioner David Kessler announced his appointment Feb. 3. In making the announcement, Kessler cited Burlington's management experience and his ability to improve the product review process. Kessler said: "Dr. Burlington has demonstrated his ability to resolve complex issues of health and public policy, and he is a strong and effective manager. His experience in enhancing product development and review across the agency -- in biologics, in generic drugs and, most recently, with new drugs -- will serve him well in the regulation of new medical technologies." Burlington has been deputy director of FDA's Office of Drug Evaluation II since 1988. In that position, according to biographical material from FDA, Burlington "reduced backlog and improved morale within the Division of Anti-infective Drug Products." That division, according to Burlington's curriculum vitae, "had the largest backlog and lowest product approval rate" within the drug center. "Currently, the division has the highest drug approval rate with virtually no backlog in the last 18 months." Burlington also has been instrumental in piloting a program for external review of new drug applications and developing a program for accelerated review of new, life-saving drugs. In a collateral assignment, Burlington played a major role in one of the most difficult FDA management situations in recent years. In 1990, former FDA Commissioner Frank Young detailed Burlington to act as the first director of the Office of Generic Drugs in the wake of the bribery scandal that enveloped that agency unit. As the temporary head of the generic drugs staff, Burlington was in charge of building an organizational structure to handle the dramatically increased number of generic drug applications while restoring integrity to the process. The task was formidable because the generic drugs review system was in disarray following the discovery that former managers and staffers of the division had accepted improper gratuities and bribes in return for preferential reviews of drug applications from some generic drug companies. Before leaving the temporary assignment in 1991, Burlington "developed policies and procedures to reestablish the integrity of the review process, and developed and implemented a management plan to reorganize the office to increase productivity," the biographical information states. Burlington's first management position at FDA came in 1986, when he became director of the division of biological evaluation and review in the Center for Biologics Evaluation and Research. He served as director of the CBER division from 1986 to 1988. Burlington began his FDA career in 1981, working as medical officer and chief of the laboratory of respiratory viruses at the Center for Drugs and Biologics division of virology. Prior to joining the agency, Burlington was a fellow at the University of Colorado Medical Center's division of infectious diseases. He earned his M.D. from Louisiana State University in 1975. The appointment of Burlington as permanent CDRH director has been widely anticipated since the Dec. 2 departure of James Benson. CDRH Deputy Director for Science Elizabeth Jacobson has been acting as device center director since Dec. 9 ("The Gray Sheet" Dec. 14, p. 2). Both Jacobson and Joseph Levitt, CDRH deputy director for regulations and policy, will continue as deputies under Burlington. Although Burlington has been the frontrunner for the top device job since soon after Benson announced his retirement in November, the appointment has not been popular with the medical device industry. The private sector is concerned that because of his background in drug regulation, Burlington will impose the more stringent "drug model" of regulation on devices. Alan Magazine, president of the Health Industry Manufacturers Association, commented on Burlington's appointment Feb. 4 at a conference in Salt Lake City, Utah. While expressing concern over the "symbolic significance" of a CDER staffer assuming device center leadership, Magazine also pledged to "try to work closely" with the new director. Former CDRH Director Benson, currently HIMA senior vice president of technology and regulatory affairs, also commented on his successor at the conference. Noting that he worked closely with Burlington during the generic drug crisis when Benson was Acting Commissioner of FDA, Benson stated that Burlington "stepped in to head up that program and I think did a fantastic job." He added: "What would be all of us is that he pays a lot of attention to deadlines." Benson also acknowledged the work that Jacobson and Levitt have done during the "difficult" transition period. The device industry's measure of Burlington's leadership will depend on his ability to improve device operations. In that regard, one of Burlington's big challenges will be to manage device center resources to meet increasing demands. Implementation of the Safe Medical Devices Act of 1990, intense oversight, and reorganization efforts have strained CDRH resources and likely contributed to the slowdown in the product application review program. Both the application backlog and a perception that FDA's device regulatory operations are less disciplined than they should be have become an issue on Capitol Hill, where House Energy and Commerce Committee Chairman John Dingell (D-Mich.) has been closely monitoring CDRH for the past year. Burlington inherits a "management action" program begun by Benson to address some of Congress' concerns by increasing the scientific rigor and efficiency of device application reviews. Burlington's experience incorporating industry user fees into the drug review program may come into play at the device center as the resource question is addressed; legislation providing user fees to CDRH may be passed in the next several years. Burlington currently co-chairs the "review management" working group of FDA's user fee steering committee. The working group is charged with designing, tracking and managing the user fee initiative at CDER. According to his curriculum vitae, Burlington also has been involved with "industry negotiations" on user fees. Burlington's experience in the area of international harmonization also should prove valuable at the device center. According to his curriculum vitae, Burlington "developed harmonization standards for clinical development and review of new drugs developed in Europe, North America and Japan." Efforts are under way at CDRH to harmonize good manufacturing practices regulations and explore the potential for harmonization of approval standards. Industry objections to Burlington also were blunted by the agency's desire to appoint a physician to the top CDRH post and the scarcity of MDs in management positions within the device center. For example, Jacobson holds a PhD in biology, and Levitt is a lawyer. None of the other senior staffers at the center hold medical degrees. The arrival of a permanent director should bring leadership stability to an FDA center that has been in transition since the middle of 1992. Burlington's appointment will enable the center to proceed with program initiatives and appointments of other permanent device center managers, such as ODE director, that have been on hold until a permanent head was named.

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