The Man with the Plan

By Dick Thompson/Washington

The food and drug industry lawyers had heard it all before. Now, here was the freshly minted FDA commissioner, still wet behind the ears at 39, giving them the usual dose of tough talk. "Ladies and gentlemen," David Kessler began, "I am here today to tell you that I place a high priority on enforcing the law." The attorneys, convened in a Palm Beach hotel, nodded obligingly. "This is not the idle talk of a new commissioner," Kessler continued, to more polite nods. Then came the surprise. "Today the U.S. Attorney's office in Minneapolis is filing on FDA's behalf a seizure action against Procter & Gamble's Citrus Hill Fresh Choice orange juice," he said. "The use of the term 'fresh' is false and misleading, and it is confusing to consumers." The nodding stopped, the lawyers grew silent, and many began to wonder, "Who is this guy?"

The guy who stunned the food industry that April morning, and many times after, is almost certainly the most capable person ever put in charge of the Food and Drug Administration. It is not a post that most folks would relish. When Kessler was appointed last December, he faced an agency that for more than a decade had been bled of funds by the White House and burdened with new responsibilities by Congress. AIDS activists were picketing the front doors because of the FDA's sluggish pace in approving drugs. Five employees had been convicted of accepting bribes from the generic-drug industry. There were allegations that other staffers were selling insider information about drug approvals to stockbrokers. And a federal report had just concluded that the agency's outmoded labs and meager staff were incapable of ensuring the safety of foods or the efficacy of new drugs.

But to Kessler, inheriting this mess is the opportunity of a lifetime, one he's been rigorously training for since college. A Harvard-educated physician and a University of Chicago-trained lawyer, he defied geography and sleep deficits to achieve both degrees simultaneously. He studied management at New York University and politics as a Senate staffer. For nine years, he ran the hospital at the Albert Einstein College of Medicine. When he was tapped for the FDA post, he was serving on a federal commission analyzing that very agency. "A lot of my background comes together here," he says. "I feel comfortable, enormously comfortable here."

Kessler always has a plan, and targeting a food-manufacturing giant such as Procter & Gamble was certainly part of one. Says Washington attorney and longtime friend Stuart Pape: "Going after large companies and being tough have been part of a well-considered strategy to increase the credibility and morale of the agency."

Inside the FDA Kessler has been just as aggressive. He's cut the time frame for legal action against a violator from 50 to 25 days. He has also begun to streamline the organization, consolidating 23 department heads into five new positions. For these spots, Kessler has recruited from the private sector a number of high-powered management consultants and Washington attorneys. Most | are in their early 40s, and some of them will be earning less at the FDA than they paid last year in taxes.

To old friends, Kessler's first target is wonderfully appropriate. The man has always had an obsession with food, and he has certainly never been a nuts- and-berries purist. "I was a fat kid," he says. In college, he was the only student in his dorm who brought an entire refrigerator from home. He kept it stocked with sodas, bagels, cream cheese and cold cuts. At Amherst, he organized a pie-throwing party after negotiating a deal for 200 strawberry- rhubarb pies. In law school he trained on pizza, Chinese food and ice cream. He still has a passion for take-out, and he starts each day with a diet cola. Back in December, at 205 lbs., Kessler was concerned that he'd cut too large a figure for a top health officer. So with characteristic discipline, he decided to reduce his calorie intake (by skipping lunch) and start exercising (usually running at 1 a.m.). Now, after altering his suits twice, he's a bony 155. Says his wife Paulette, an attorney: "He just has incredible willpower, and he's very focused."

And yet those who know Kessler invariably comment on his more human side. Everyone has a Hallmark-card story about him. It usually involves some very sick child and the extra effort Kessler went to in order to make life a little better. As a resident at Johns Hopkins, he arranged for a day at the ball park for a child dying of cancer. He is also a dedicated family man who makes time for baseball and bedtime stories with his two kids.

Kessler is one member of the '60s generation who never lost the naive conviction that an individual can change the world. Deceptive food labeling troubles him because it is dishonest and unfair. And, without warning, he can break into a mini-sermon about the FDA: "There are 8,000 wonderful people here. They came here because they wanted to protect and promote the public health, and my job is to let them do their job."

While both the White House and Congress are pleased by his performance so far, FDA watchers outside government are skeptical that he will succeed in reversing the fortunes of his agency. "You can deal with orange juice easily, but pretty soon you've got to get down and deal with the real inadequacies," says Charles Edwards, a former FDA commissioner who chaired the government panel that examined the agency's shortcomings. The food industry believes Kessler is pushing too far, too quickly. Consumer activists are waiting to see what he will do about a range of food-safety issues, such as fish inspection, food additives and pesticide residues. Drugmakers are still waiting for the FDA to break the logjam of new drug applications. Approval currently can take as long as three years, and there is a backlog of 271 drugs waiting for FDA action. But Kessler remains confident. "There's nothing that isn't manageable," he says. So far, he's done a good job of making that sound credible.