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FDA Commissioner Kessler Will Resign Early Next Year

By John Schwartz
The Washington Post

David A. Kessler, who extended the regulatory ambit of the Food and Drug Administration into everything from orange juice labels to tobacco, announced Monday that he will resign early in the coming year.

Kessler said he was stepping down voluntarily after six years as commissioner because he had accomplished his major goals: "We did what we set out to do," he said.

Yet it had become clear to FDA observers that Kessler had become a major target of the anti-regulatory mood in Washington. Kessler's departure could free the Clinton administration to broker agreements on contentious issues ranging from FDA reform to the controversial proposal for the the agency to regulate tobacco.

Kessler, a 45-year-old pediatrician and attorney, said he had no immediate career plans. Before taking the FDA job, he had served as medical director of Albert Einstein Hospital in the Bronx, New York, and said he would be happy to return to such work.

Kessler also said he would stay until a successor was named. Though he said he did not know who the president might choose, Kessler said several top officials at the agency are capable of running it. Respected current and former FDA officials include deputy commissioners Mary Pendergast, William Schultz, and Michael Friedman, as well as former FDA official Michael Taylor, now heading up the food safety program at the Department of Agriculture.

During his tenure, Kessler implemented a list of initiatives that transformed the beleaguered agency and U.S. public health policy. Those include the creation of a uniform nutrition label on packaged food that simplified choices for American consumers, as well as the proposed youth smoking curbs and speedier approvals of drugs and most medical devices.

"David Kessler represents the best that Americans can give in public service to their country - a tireless commitment to better the lives of our citizens," said President Bill Clinton in a statement. "His contributions to improve the health of our nation are many and their effect will continue to be felt for generations to come."

But Kessler was criticized from both ends of the political spectrum - from AIDS activists who accused him of delaying approvals of life-saving drugs to conservatives who accused him of heavy-handed government regulation of everything from vitamins to cigarettes. Attacked as a glaring example of the overprotective "nanny state," Kessler's FDA has been a target of sweeping regulatory reform efforts.

Many of Kessler's detractors were elated by his announcement, which "is great news both for FDA and for the public health," said former FDA general counsel Peter Barton Hut. "The FDA is in the worst state of disarray in four decades," said Hut, who has consulted with industry to help draft FDA reform proposals and who has also been mentioned as a candidate for Kessler's job. "The agency now needs a real leader who will focus on the agency and not on their own personal agenda," Hut said.

Hut and other Kessler critics characterized him as an overzealous regulator who put publicity-grabbing initiatives before issues of public health. Many criticized Kessler, for example, for a high-profile seizure of 40,000 gallons of Procter & Gamble orange juice that had been labeled "fresh" which had actually been made from concentrate. And others said that his decision to declare a moratorium on the use of silicone breast implants because of health concerns was premature and ultimately not justified by the science.

Others who had locked horns with him had little to say Monday. The Tobacco Institute said it had no comment (though tobacco stocks rose sharply), nor did the Pharmaceutical Research and Manufacturers Association.

Rep. Thomas J. Bliley, R-Va., chairman of the House Commerce Committee who once excoriated the "bureaucrats in Rockville (Md., where FDA offices are located)," said only, "I wish him well," through a spokesman. Rep. Joe Barton (R-Texas), whose Commerce subcommittee had oversight authority over the FDA and who sponsored a failed bill to loosen medical device regulation, said that "it's a decision that was overdue." Kessler's absence could pave the way to a bipartisan bill to reform the agency, said Barton.

"I don't think there's any other commissioner in my memory who's had the kind of impact David Kessler has had," said Rep. Henry A. Waxman (D-Calif.).