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Executive Summary

FDA COMMISSIONER KESSLER EXPECTED ON THE JOB EARLY IN DECEMBER; introductory briefings at the agency will begin during the next two weeks as the commissioner makes the move from New York City to his new job. Because of his knowledge of the agency and his familiarity with current issues through his work on the Edwards Committee, David Kessler, MD, is likely to have a very short transition term. HHS is expected to hold an informal swearing-in ceremony toward the end of this month to get Kessler officially into the post, followed by a more formal ceremony. Acting Commissioner James Benson will continue to run the agency for the next month. Kessler was confirmed as FDA commissioner by the Senate Oct. 27 following approval by the Senate Labor & Human Resources Committee earlier that day. The committee voted to approve Kessler as FDA commissioner in a brief executive session and then sent the nomination directly to the Senate floor. To save time, the committee did not hold a formal hearing. In an Oct. 29 statement on Kessler's confirmation, HHS Secretary Sullivan said: "I am especially gratified that the Senate has acted expeditiously to confirm Dr. David Kessler as commissioner of Food and Drugs. Dr. Kessler will provide strong, innovative leadership at the Food and Drug Administration." Sullivan added that "I also want to thank James Benson, who has served ably and diligently as acting commissioner of Food and Drugs." To take the FDA post, Kessler is resigning his position as medical director of the Jack Weiler Hospital of the Albert Einstein College of Medicine/Montefiore Medical Center. Kessler will take a leave of absence from his academic appointments -- he teaches at the Albert Einstein medical college and at Columbia law school -- as well as his hospital practice. The incoming commissioner is expected to maintain his contact with the HHS Advisory Committee on FDA (also known as the Edwards Committee) although he will resign as a voting member. He plans to attend the Nov. 8-9 meeting of the committee's Subcommittee on Human Drugs and Biologics in La Jolla, Calif. but will no longer chair the group. Lawrence Horowitz, MD, subcommittee member and former staffer to Sen. Kennedy (D-Mass.), will preside at that meeting. Sen. Kennedy said in a statement at the Labor Committee's executive session on Kessler that his committee may hold a hearing on FDA to elicit Kessler's views early in the next session. Referring to a written question and answer exchange with Kessler, Kennedy said the new commissioner "has made a commitment to the protection and enhancement of public health, the strong enforcement of the law and to take whatever action is necessary to restore the agency's credibility." Kennedy added that the committee plans "oversight" hearings with Kessler during the next session "to explore more fully these and other pertinent issues." In a separate statement on the nomination, Labor Committee Ranking Republican Hatch (Utah) commented that "we need Dr. Kessler at FDA as soon as possible." He pointed out: "The next commissioner of the FDA has a significant job ahead of him as he provides FDA leadership. The Food and Drug Administration has faced many crises during the past decade. They include the tampering with over-the-counter products, tainting of the food supply, and fraudulent generic drug applications... Through this adversity, the FDA needs a new burst of energy, leadership, and revitalization. Dr. Kessler will bring to the agency these qualities." Sen. Gore (D-Tenn.) is likely to be invited to attend the Labor Committee hearings next session on Kessler. Gore is the author of the legislation requiring Senate confirmation of the commissioner. EDITORS' NOTE: "The Pink Sheet" incorrectly listed the date for the La Jolla meeting as Nov. 19 in an Oct. 29 article, p. 3.



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