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FDA DRUG CENTER ESTABLISHING TWO NEW PERMANENT DEPUTY DIRECTOR POSTS

This article was originally published in The Tan Sheet

Executive Summary

FDA DRUG CENTER ESTABLISHING TWO NEW PERMANENT DEPUTY DIRECTOR POSTS by July 1, agency staffers said. The Center for Drug Evaluation and Research plans to establish the positions of deputy director for review management and associate director for scientific and medical affairs as part of its plan to ease the transition following the retirement of CDER Director Carl Peck on Nov. 1 and CDER Deputy Director Gerald Meyer in January 1994 ("The Tan Sheet" May 10, In Brief). CDER is sending a letter to all Senior Executive Service level physicians in the drug center inviting them to consider taking either position. Recruitment will be within CDER only. FDAers eligible for the jobs are office directors and division directors. One of these deputies most likely would be asked to become acting director of the center when Peck leaves. The center's other objective in creating the deputy-level positions is to give the two appointees the responsibilities that Bruce Burlington had when he was CDER's deputy director for scientific and medical affairs. Burlington, who also held the title of Office of Drug Evaluation II deputy director, became director of the Center for Devices and Radiological Health in February. His numerous CDER responsibilities currently are distributed among many officials including Peck, Office of Generic Drugs Director Roger Williams, Division of Anti-Infective Drugs Director Murray Lumpkin, Office of Drug Evaluation I Director Robert Temple and ODE II Director James Bilstad. Among other duties, the deputy director for review management would implement and coordinate the drug user fee program, which will require the development of policies, allocation of resources and recruitment of reviewers. The deputy director will have line authority, with office and division directors reporting to him or her. The responsibilities of the associate director of scientific and medical affairs will include: intercenter agreements and coordination; recruitment; FDA's new drug adverse event reporting program, Medwatch; medical emergencies; international harmonization and international affairs. Deputy Commissioner for Operations Jane Henney is putting together a search committee to find a replacement for Peck; a nationwide search is planned. The committee may be up and running in two to four weeks. The committee most likely will be composed of individuals from CDER, other centers within FDA, other federal agencies and academia. Committee members will decide which medical journals should carry ads soliciting CDER director candidates. As is the usual practice, the position probably will be advertised in federal employment bulletins. Peck, 51, is retiring after 26 years of government service, the agency announced May 18. He will join Leiden University in the Netherlands as Boerhaave Professor of Clinical Drug Research for an eight-month sabbatical. Peck said he has no plans for what he will do after his sabbatical. At Leiden, Peck will be associated with the Division of Pharmacology in the Center for Bio-Pharmaceutical Sciences where he will teach and conduct research in clinical and preclinical drug research. Peck came on board FDA as CDER director when the centers for drugs and biologics were reorganized in 1987. FDA recruited Peck from the Uniformed Services University of the Health Sciences, where he was director of the Division of Clinical Pharmacology from 1980-1987. He received his medical degree from the University of Kansas Medical Center in 1968. Peck has received many awards for his work at FDA, including the U.S. Army's Superior Service Medal, the Commissioner's Special Citation and the Public Health Service's Outstanding Service and Distinguished Service Medals. He holds the rank of admiral in the PHS. Commenting on Peck's career at the agency, FDA Commissioner David Kessler said: "Dr. Peck brought to FDA the spirit of innovative scientific management." Kessler also noted that Peck "was personally committed to strengthening the generic drugs and AIDS programs." In addition, the Office of OTC Drugs was created during Peck's tenure. As director of CDER, Peck spearheaded new procedures for reviewing new drugs and providing earlier access to therapies: expedited approval of drugs for life-threatening diseases, parallel track and accelerated approval. Along with John Harter, Peck created the Pilot Drug Evaluation Staff, which developed the innovative review method of "NDA Days" and implemented the concept of managed reviews. Under Peck, CDER's computerization was brought up to speed. In the aftermath of the generic drug scandal, Peck oversaw the revamping of the generic drug approval process, the reorganization of the generic drug division and the hiring of a new director, Roger Williams. Peck said he feels "very good" about these achievements and others including the increased scientific caliber of individuals in CDER. Besides Williams, Peck brought in Lumpkin; David Feigal, director of the antiviral drugs division; Jerry Collins, director of the Office of Research Resources; Thomas Ludden, director of the Division of Biopharmaceutics; Lawrence Lesko, associate director for research in the Office of Generic Drugs; and Michael Weintraub, the expected director of the OTC office. In April 1988, Peck hired Merck exec William Abrams to set up and organize the Professional Development Staff, which was established to improve recruitment and retention of medical reviewers. The CDER official encouraged his staff to keep abreast of the changing science of drug development. Peck's research interests focus on pharmacokinetics, data analysis and experimental design. Peck described his time at the agency is "the most fantastic experience I've ever had." He said that it has been "a marvelous privilege" to work at FDA and to "work with such fine people on such important issues."
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