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CDER DIRECTOR CANDIDATE SHORT LIST EXPECTED BY NOV. 1

This article was originally published in The Tan Sheet

Executive Summary

CDER DIRECTOR CANDIDATE SHORT LIST EXPECTED BY NOV. 1, the date which current Director Carl Peck is scheduled to retire from the agency ("The Tan Sheet" May 24, p. 9). FDA Deputy Commissioner for Operations Jane Henney has asked the director search committee to forward a list of four candidates for the top post at the Center for Drug Evaluation and Research by that date. The search committee, which is chaired by Center for Devices and Radiological Health Director Bruce Burlington, met for the first time during the week of June 28. In addition to the CDRH director, Center for Biologics Evaluation and Research Director Kathryn Zoon is on the committee. The commissioner's office is represented by Senior Advisor for Science Elkan Blout. Office of Regulatory Affairs Enforcement Office Director Dan Michels also is on the committee. The only drug division director participating in the deliberations is newly appointed Medical Imaging Surgical and Dental Division Director Patricia Love. From outside FDA, the agency has recruited Lawrence Horowitz, MD, a former staffer for Sen. Edward Kennedy (D-Mass.) and current president of Selby Lane Enterprises. Horowitz served on the Edwards "blue ribbon" advisory committee to FDA, which made recommendations on improving the drugapproval process. The National Cancer Institute is represented by its director, Samuel Broder, MD. Three current members of drug advisory committees are in the recruiting group as well. They include Generic Drugs Advisory Committee Chairman Terrence Blaschke, MD, Stanford Medical Center, and a member of that same committee and Leslie Benet, PhD, University of California at San Francisco. The third member from an advisory committee is University of Chicago anesthesiologist Michael Roizen, MD, from the Anesthetic & Life Support Drugs Advisory Committee. Pharmaceutical industry and medical associations are not represented on the committee. However, FDA has sent letters to all major trade associations, including the Nonprescription Drug Manufacturers Association, and medical groups soliciting their nominations for center director. NDMA said it has asked its members for suggestions on CDER director nominees. However, the association is not sure whether it will ultimately recommend a candidate. With the selection of a new center director moving forward, the agency is acting quickly to appoint two new permanent deputies to the director who will assume responsibilities relating to user fee implementation and oversight of intercenter agreements. Five candidates for the deputy positions were interviewed during the week of June 28. Reportedly those interviewed were: Office of Drug Evaluation I Director Robert Temple; Office of Generic Drugs Director Roger Williams; Anti-Infective Drugs Division Director Murray Lumpkin; Pilot Drug Staff Director John Harter; and Office of OTC Drug Evaluation Director Michael Weintraub. An announcement on the deputy positions is expected the week of July 12. A search team also has been formed to select a permanent director for the Office of Compliance. Eleven candidates were interviewed during the week of July 5 for the position, which has been filled by acting director Paul Vogel since Dan Michels left the office in January to head up FDA's Office of Enforcement. Vogel, who was deputy director under Michels, is considered a strong candidate for the permanent director slot.
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