FDA’s Kessler Quits; Battled Tobacco Firms
Food and Drug Administration Commissioner Dr. David A. Kessler announced his resignation Monday, ending a controversial six years in which he restored the agency as an aggressive public advocate and battled Congress and the cigarette industry over regulation of tobacco.
“I’ve been focused on several important issues, and I’ve tried to make a difference,” Kessler, 44, said in an interview. Although the Clinton administration tried to persuade him to stay, Kessler said he felt he had completed most of the objectives he set for himself when appointed by then-President Bush in 1990.
While best known as the architect of the administration’s initiative to restrict teenagers’ access to tobacco, Kessler also made the enforcement of food and drug safety and fraud laws a top priority; successfully engineered a major overhaul of the nation’s food labels; and streamlined the drug review process to accelerate the approval of therapies for life-threatening illnesses such as cancer and AIDS.
“Kessler’s legacy is not tobacco, it’s the FDA and what he did for it,” said William Vodra, an attorney specializing in food and drug law whose firm represents tobacco giant Philip Morris. “You can disagree with some of the things he did, but he restored the FDA as a good agency out to protect the public.”
Perhaps Kessler’s most far-reaching accomplishment was to win standard nutritional labeling on virtually every food product sold in America, giving consumers simple, yet detailed, information for the first time about what they eat.
In acknowledging the many changes at the FDA, Kessler said the agency’s “commitment to protecting the public health runs deep and is a source of great pride” for everyone working there.
Kessler said he would remain until a successor is found, and said he had no immediate plans. A lawyer and a pediatrician, Kessler came to Washington from the Albert Einstein College of Medicine in the Bronx, where he had been medical director since 1984.
President Clinton, who was concluding a trip to Asia on Monday, said in a statement that Kessler’s “contributions to improve the health of our nation are many, and their effect will continue to be felt for generations to come.”
While Kessler’s efforts were embraced by the administration and congressional Democrats, he found tough going in recent years when Republicans assumed control of Congress. GOP leaders were outraged at the agency’s attempts to regulate tobacco, and tried unsuccessfully to reduce its authority over the drug and medical device industry.
The tobacco initiative announced by Clinton last summer would establish 18 as the minimum age to legally purchase tobacco products and would severely curtail advertising and promotions targeted toward teens. The initiative would also ban the sale of cigarettes from vending machines in all locations except those not frequented by teenagers, such as bars.
The FDA, which conducted a painstaking investigation of nearly two years, built its case for jurisdiction over tobacco on the fact that nicotine is considered addictive and that industry can manipulate the levels of the substance in its products.
The regulations still face a court challenge by the industry and also could be the focus of future congressional action. But numerous FDA watchers predicted that Kessler’s departure will have little effect on the outcome now that the agency rule has become final, and because it has the backing of the administration.
“As for tobacco, the die is cast,” said Vodra, who was FDA associate general counsel between 1974 and 1979. “The agency has taken its position. The president has signed off on it, and has been reelected. It’s up to the lawyers and the Department of Justice to argue the case--they don’t need a commissioner to do that.”
Rep. Henry A. Waxman (D-Los Angeles), who as chairman of the House Commerce Committee’s subcommittee on health led the congressional investigation of tobacco when the Democrats controlled Congress, expressed a similar opinion.
“The FDA has done its part, and now it’s in the hands of the courts,” he said. “If the courts uphold the FDA regulations, they will become law. He’s already put the regulations in place and established the agency’s jurisdiction.”
The Tobacco Institute, the industry’s lobbying arm, declined comment on Kessler’s departure.
Others, however, made it clear they were happy to see him go--particularly representatives of the medical device industry who believe that the agency still takes too long to approve new products.
The Health Industry Manufacturers Assn., makers of medical devices, said: “We look forward to working with Dr. Kessler’s successor to improve the climate for innovation.”
Rep. Joe L. Barton (R-Texas), a vocal critic of Kessler, said his departure will open the way for reforms. Kessler “might have been an impediment” to congressional efforts to transform the agency.
When Kessler took over at the FDA, the agency was reeling from a generic-drug industry scandal, in which several drug reviewers admitted accepting bribes from generic drug companies in exchange for faster reviews.
Kessler tried to establish a tone that would return the agency to its original mission as a consumer watchdog.
One of his first actions was to crack down on major food companies for deceptive package labeling, essentially sending the message that the agency under his direction intended to enforce the rules. He dispatched agents to seize Procter & Gamble’s Citrus Hill Fresh Choice orange juice from a Minnesota warehouse after the company ignored demands to remove the term “fresh” from its label because the juice had been processed.
While Kessler had been expected to stay for at least part of a second term, it was known that his family had grown tired of Washington politics. Even Kessler himself occasionally joked about the city’s style, once telling a reporter that he “couldn’t wait to get home every night to wash off the dirt.”
