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Crusading Kessler steers FDA into smoking debate

ROCKVILLE — ROCKVILLE -- To the tobacco industry, Food and Drug Commissioner David A. Kessler has become Public Enemy No. 1 -- a wild-eyed government chief about to unleash his insatiable regulatory appetite on an unsuspecting nation. To the anti-smoking crusaders, he is a knight on a white horse -- the right man at the right time.

But as the intense, bearded and bespectacled bureaucrat nears a decision that could forever change the place of cigarettes in our society, he has left anxious parties on both sides of the issue wondering: Just what does Dr. Kessler really want?

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No stranger to controversy, or to the deft political maneuverings needed to win public support for his agenda, Dr. Kessler has signaled to all that, unlike his predecessors who steered clear of the smoking debate, he is entering the fray.

"Add up the risk posed by everything else that we regulate and I would guess that the totality of all that risk doesn't even come close to the risk that cigarettes pose," he said in an interview in his office.

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With a fierce streak of independence tempered by keen political instincts, Dr. Kessler, 43, has charted a course from a Republican to a Democratic administration and through a minefield of controversial issues: from breast implants to vitamin labeling and now, to cigarettes.

The smoking debate is likely to be his toughest, most explosive battle yet, and the defining chapter of his activist FDA stewardship.

In June, he told Congress that he finally had proof that tobacco companies manipulate the nicotine in cigarettes to try to hook consumers -- evidence that the industry views nicotine as a drug, he insists. Earlier this month, an FDA advisory panel concluded that nicotine in cigarettes was, in fact, addictive.

Now, as dozens of employees puff away their lunch breaks standing outside the dark glass FDA building in suburban Maryland, administration scientists are closing in on the answer to a question that could lead to further, and possibly profound, restrictions on smoking: Is the nicotine in cigarettes a "drug" and therefore subject to FDA regulation?

Let me assure you we're working very hard to answer that question," Dr. Kessler said, unwilling to reveal how close he is to what would be a landmark pronouncement. "There's been a chipping away over the last 30 years, but there is a momentum now on this issue. We are very much at a turning point."

If Dr. Kessler decides that the FDA should regulate cigarettes, as the tobacco industry both fears and expects, he has the authority to go as far as banning cigarettes outright.

He says he will not do that, recognizing that, aside from igniting a political wildfire, such a ban would create a black market and unfairly punish the millions already addicted.

"Prohibition doesn't work," says Dr. Kessler, a lawyer and doctor who trained for three years at Johns Hopkins Hospital. "We know that."

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'Children's disease'

Rather, he intends to concentrate on preventing the next generation from taking up the habit.

"The real important thing for me is, if you don't start smoking by age 21, you don't start smoking," says Dr. Kessler, the father of two young children, who looks at smoking as a "children's disease."

"If we could prevent kids from starting to smoke or become daily users before the age of 21, we're not going to have the next generation smoking."

He says he would favor restricting access of cigarettes to minors by limiting sales to designated stores, much as the sale of alcohol is restricted in some states, and possibly eliminating cigarette machines.

He supports placing further regulations on cigarette advertising to avoid sending the message that smoking is adventuresome and hip.

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"The messages we send children through advertising is that there are a lot of benefits that go with smoking," he says. "Take the companies at their word that they don't target children. The impact of their actions is that they're having an effect on children. If I ask my elementary-school child who Joe Camel is, and the answer is that: 'I know not only Joe Camel, I know Josephine,' it has a real effect."

Although they realize some change is inevitable given today's increasingly anti-smoking climate -- when states such as Maryland are trying to ban smoking from all workplaces and even McDonald's has declared itself a smoke-free corporate zone -- tobacco executives take little comfort in Dr. Kessler's stand against prohibition.

"He could issue a set of regulations that would be the functional equivalent of a ban," says Walker Merryman, vice president of the Tobacco Institute. "I think he wants total control over the regulatory aspects of tobacco."

It is hardly the first time the commissioner has thrust himself into a hot seat. The FDA, responsible for monitoring one-fourth of the nation's gross domestic product, seems to face a new controversy at every turn -- AIDS drugs one day, genetically altered tomatoes the next.

Some have charged that, with a flair for the theatrical and an adman's sense of public relations the FDA chief is striving merely to turn himself into a folk hero, in the style of former Surgeon General C. Everett Koop, through his regulatory zeal.

But most in the food and health sector praise the commissioner as a well-meaning chief, courageous enough to stick up for the consumer and put teeth, and credibility, back into an agency that had been mired in scandal and inactivity.

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Appointed in 1991 by President George Bush on the heels of a scandal in which generic-drug manufacturers falsified test results and bribed FDA officials, Dr. Kessler wasted no time making his mark.

Two months after being sworn in, he ordered the seizure of 2,000 cases of Procter & Gamble's Citrus Hill Fresh Choice orange juice on the grounds that the reconstituted juice was falsely labeled "fresh." He acknowledged then that his actions were a signal that his FDA would be a regulatory force to be reckoned with.

Since then, he has clamped down on drug companies whose plants have not met FDA standards; rankled the vitamin industry by proposing restrictions on labels of food supplements; and led the enforcement of new, consumer-friendly food labels that more accurately describe fat content and nutrients.

"This is a guy who believes you can make the regulatory system work," says Michael A. Simmons, a friend who was a faculty member at Johns Hopkins Medical Center when Dr. Kessler was an intern and resident there.

He has won the admiration of many in the AIDS community for speeding the drug-approval process. "He is at least trying to fix a broken system," says Linda Dee, president of the Baltimore AIDS Action Council.

Last April, in one of his most highly publicized and controversial moves, Dr. Kessler banned silicone-gel breast implants for cosmetic purposes after two years of FDA study on the health risks of such devices.

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Several who worked on the implants issue say that, in addition to putting 150 staffers on the case, Dr. Kessler conducted 14-hour meetings, even on weekends, and took files home to read every night.

'So focused'

"I've never seen a commissioner so focused," one associate said. "He had the sense this was a very provocative, high-profile, rife-with-publicity issue. That helped him with the focus. David senses that sort of thing. Smoking is clearly that way."

Joining tobacco executives who fear his heavy hand are those in other industries who say the commissioner's stringent regulatory policies have created friction between government and business.

Many in the medical-devices industry say new laws demanding more testing and trials have swelled the backlog for approval of potentially life-saving products, a backlog described as "intolerable" in a report last year by a House subcommittee.

"We can do things faster," says Dr. Kessler. "We can also be more thorough. Which would you like?"

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For the most part, Dr. Kessler's regulatory appetite is more in sync with the Democratic administration that inherited him than with the deregulating Republican regime that appointed him. Near the end of the Bush administration, in fact, his independence had so angered Republicans that he was nearly ousted.

Dr. Kessler was held on by President Clinton, as few high-ranking Bush appointees were, through what a former FDA official called "some damn good politicking" -- namely, lobbying through his deputies, some of whom have close Democratic ties.

But his intensely political style doesn't translate into deep partisan convictions. Dr. Kessler switched parties and became a Republican in 1981 in order to work on food and drug issues for Republican Sen. Orrin G. Hatch of Utah, then chairman of the Labor and Human Resources Committee.

Not surprising for someone who pursued, at the same time, a law degree from the University of Chicago and a medical degree at Harvard, Dr. Kessler worked on Capitol Hill while doing a pediatric residency at night at Hopkins in the early 1980s. It was clear to fellow students and teachers that David Kessler had his eye on a career in Washington and, as Dr. Simmons says, "something big and macro rather than small and micro."

Enhancing an already staggering resume, the New York native was appointed, at age 33, director of medicine at Albert Einstein College of Medicine in the Bronx, N.Y., while teaching law and earning a graduate certificate in business.

Now, for the first time in his life, he says, he is so engrossed in his work that he does not have his eye on the next step. The smoking debate, after all, has been percolating on the back burner of his activist agenda for years.

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As early as 1991, when he took hold of the reins at the FDA at age 39, he knew he would eventually strike the match.

"Give me time," he told his deputies. "We will get to this issue. There's a time and a place."


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