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The FDA's authority to regulate tobacco was argued today in a federal court in North Carolina, and the issue may well end up in the Supreme Court. Those regulations were adopted under the watch of Food & Drug Administration Commissioner David Kessler, who has announced he will leave the agency later this month. Here's a parting interview with him.

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ELIZABETH FARNSWORTH: Now, the outgoing head of the Food & Drug Administration. As we reported, the FDA's authority to regulate tobacco was argued today in a federal court in North Carolina, and the issue may well end up in the Supreme Court. Those regulations were adopted under the watch of FDA Commissioner David Kessler, who has announced he will leave the agency later this month. Margaret Warner recently spoke to him.

MARGARET WARNER: David Kessler will soon step down from the job of FDA Commissioner after six stormy years in the post. We'll talk to Dr. Kessler about his tenure, but first this background from Kwame Holman.

KWAME HOLMAN: David Kessler was picked by President Bush in 1990 to head the Food & Drug Administration. At the time the regulatory agency was considered hopelessly bureaucratic by critics on Capitol Hill and elsewhere and beset by cases of corruption that resulted in prosecution of agency employees. The Food & Drug Administration was established in 1906, after tainted food scandals involving meat packing. Today the agency certifies the safety of virtually all food products and tests new drugs and medical therapies before they're sold or used.

DR. DAVID KESSLER, Food & Drug Administration: (March 3, 1995) Our mission, as the nation's oldest consumer protection agency, is to provide basic public health protection for the foods we eat, for the drugs we take, and the medical devices we use.

KWAME HOLMAN: From the beginning of his tenure pediatrician and lawyer Kessler said he'd be an activist and aggressively pursue strict health and safety standards. And it didn't take long for Kessler to make headlines. In 1991, he ordered the FDA to seize 40,000 gallons of Proctor & Gamble Orange Juice that was labeled "fresh" but had been made from concentrate. That began a series of Kessler initiatives his critics called "overzealous" and designed more to grab publicity than to address serious public health issues. That same year Kessler revolutionized food product labeling by requiring that uniform nutritional information be listed on all packaged food. Food makers not only had to be more specific and accurate in their labeling, the FDA also cracked down on what Kessler called widely misused terms such as "fresh" and "low fat." The agency set strict standards for use of all such terms. In 1992, Kessler imposed a moratorium on the use of silicone implants for cosmetic breast surgery.

DR. DAVID KESSLER: (1992) One of the things that concerns me most is that breast implants may rupture, leak, or bleed more frequently than we had originally thought. We had been told that these are rare events. How often do these devices actually rupture? What happens to these devices ten or twenty or thirty or fifty years after implantation?

KWAME HOLMAN: But some in the medical community and in Congress said Kessler's silicone implant decision was premature and not justified by scientific findings. For years, the FDA had been criticized for taking too long to approve the sale of new drugs. In 1993, Kessler allowed drug manufacturers to pay a fee to get their products reviewed more quickly. One result was approval times were reduced by several months. Kessler also developed an even speedier fast-track approval process for therapies for life-threatening illnesses, such as cancer and AIDS. But for some in Congress the process still was too slow. After Republicans became the majority in both Houses of Congress in 1995, Kessler's agency came under fresh scrutiny. At a Capitol Hill hearing that year, the FDA was accused of being hostile to the industries it regulates.

REP. JACK KINGSTON, (R) Georgia: (1995) The No. 1 criticism cutting through all this is that FDA is antagonistic, rather than conciliatory. Those people come to ‘em. You don't have a "can do" attitude; you have a "can't do" attitude towards the drug company or the medical device manufacturer, or something like that.

DR. DAVID KESSLER: You don't think, Congressman, that I want to get a device that is going to improve people's lives out there as soon as possible? I know it's not politically correct to say this these days, but I am and the agency is a regulatory agency.

KWAME HOLMAN: But the criticism from Republicans continued. Newt Gingrich once called Kessler "a thug and a bully," and presidential candidate Bob Dole said Kessler would have no place in a Dole administration. Kessler might be best known outside Washington for his high profile run-ins with the tobacco industry. Early in his tenure he suggested the FDA should consider regulating the nicotine and tobacco products as a drug. Then at a March 1994 congressional hearing Kessler accused tobacco companies of manipulating nicotine levels in cigarettes.

DR. DAVID KESSLER: Whose choice is actually driving demand for cigarettes in this country? Is it a choice by consumers to continue smoking, or is it a choice by cigarette companies to maintain addictive levels of nicotine in their cigarettes?

KWAME HOLMAN: Despite industry complaints, Kessler's anti-tobacco efforts culminated in a presidential initiative last summer. It established 18 as the minimum age to purchase tobacco products legally. Tobacco advertising and promotions targeted at teens were severely curtailed, and cigarette vending machines were banned from places frequented by young people.

MARGARET WARNER: And joining us now is David Kessler. Welcome.

DR. DAVID KESSLER, Food & Drug Administration: Thanks for having me.

MARGARET WARNER: Do you leave this job thinking you have made a real and lasting difference?

DR. DAVID KESSLER: We've tried. FDA is the most important consumer protection agency in the world. Just think about it. We have a responsibility for the safety of all foods, except meat and poultry, all drugs, cosmetics, medical devices. Our job is to protect and promote the public health. I think we've done a pretty good job.

MARGARET WARNER: Why do we need, in your view, such an activist government in protecting public health and safety? I mean, 50 years ago the FDA, while it existed, was certainly not half as aggressive as it is now. And yet people didn't die by the thousands from, from tainted meat and drugs. Why do you feel we need such an activist agency such as yours?

DR. DAVID KESSLER: First of all, I take exception to your statement that people didn't die, I mean, people today still, I mean, have ill effects from the foods that we eat, certainly not in numbers that we had at the beginning of the century, and the food industry has done a tremendous job, but even several months ago, remember the unpasteurized apple juice, and the deaths from that? I think that the American people expect us to be vigilant.

MARGARET WARNER: Do you think technology and science and medical advancement has also changed the nature of what's necessary?

DR. DAVID KESSLER: Oh, absolutely. Last year--this last year we approved 52 new molecular entities, new drugs whose chemical structure never existed before. We never had that many new drugs, and that's because in this nation's investment in biomedical science, we're reaping those rewards. I mean, there's real hope there, a hope that we've never seen before. The next 15 years we'll see discoveries that really will change medicine from an art into a science.

MARGARET WARNER: Now, your critics on Capitol Hill, Sen. Orrin Hatch, others, as we've just seen in the taped piece, say that the FDA under you demanded essentially zero risk and that, in fact, stood in the way of a lot of these wonderful advances and that people paid a price in being denied life saving drugs, or other, other treatments. What do you say to those critics that in a way your standards are too absolute?

DR. DAVID KESSLER: I ask them to name one drug, one therapy that's available somewhere else that works and is not available here in this country. Every single age drug--we have nine now available--were approved here first in this country. And it's not just AIDS. It'S drugs for Alzheimer's disease. It's drugs for ovarian cancer. This country is the world's leader. Yes, we have high standards. Yes, I stand and the agency stands and believes in those high standards, but we also can do it efficiently and get drugs to patients who need them rapidly.

MARGARET WARNER: All right. Let's turn to the tobacco issue, because that's one, of course, you've taken a lot of criticism on. Tobacco--I mean, cigarette packs have a warning on them. I think every American knows that cigarettes are dangerous for their health. So have you--I know you don't think so--but where is the line between protecting health and safety and becoming essentially--as your critics would say--a national nanny for Americans who have to, after all, take some responsibility for their own health?

DR. DAVID KESSLER: The tobacco companies argue that smoking is a choice, that it's an adult choice. They're simply wrong. Ask a smoker when he or she began, and you'll hear the tale of a child. And it's not only that children are beginning to smoke at eleven, twelve, or thirteen, but they're becoming addicted by sixteen, seventeen, or eighteen. You're dealing with an addiction. You're not dealing with a choice. And it's not adults who are becoming addicted. It's children and adolescents who are becoming addicted.

MARGARET WARNER: All right. But if it's that dangerous, then why wouldn't the government ban them altogether?

DR. DAVID KESSLER: I think you've seen the president. You've seen this agency for the first time in 30 years stand up and put into place measures, reasonable measures, things that I think whether you're a smoker or a non-smoker, whether you're from Kentucky, or you're from Maine, make sense. They're aimed at reducing young people from starting. There are 50 million smokers in this country, 35 to 45 million of whom are addicted. Prohibition simply wouldn't work.

MARGARET WARNER: All right. Let's turn to another, earlier decision of yours on silicone breast implants. And at that time when you put the moratorium on their use for cosmetic purposes, the feeling was that the science was not completely conclusive.

DR. DAVID KESSLER: It wasn't there. The data was not there.

MARGARET WARNER: Now, you wouldn't approve a drug if the data weren't there that it was safe and effective. Why, essentially, unapprove something when the data was incomplete?

DR. DAVID KESSLER: Because the law requires it. The law gave the manufacturer a period of time. In fact, it had over a decade in which to collect that data, and they didn't do it.

MARGARET WARNER: So you mean the burden was on them?

DR. DAVID KESSLER: Exactly.

MARGARET WARNER: All right. Let's turn to another one. We didn't refer to it in the taped piece, but where Congress did clip your wings in a way, and that had to do with your attempt to bring nutritional and dietary supplements, the kind of things we see in health food stores and so on, under the same requirements to prove their own efficacy and safety as over-the-counter drugs and prescriptions. Now you lost that battle in ‘94. Congress essentially protected those drugs from that standard. Why--this is maybe a more political question--why did you lose that battle when you won so many others?

DR. DAVID KESSLER: It's a good question. I'm not sure I know the answer. There was a lot of political pressure by a lot of special interests brought on the Congress. What we said is that before you go make a claim, before you say this dietary supplement is useful in treating cancer or heart disease, or is good for you for certain health reasons, that you have the scientific data. That's what we stood for. There's a lot of miscommunication. People said we were going to make all dietary supplements by prescription. That was absolute nonsense. We weren't going to provide access to dietary supplements. It couldn't be farther from the truth. What we simply said was if you're going to make a claim that you be able to have the data, that you be able to support it. And Congress reduced the standards, lowered the standards somewhat, not entirely, made it more difficult for us to regulate those products. So when you walk in today to a store and you see those dietary supplements, you see many of them, you assume that we've done our job. You can't make that assumption.

MARGARET WARNER: This Congress, this Republican Congress and also even the Democratic Congress before, in fact, it was the Democratic Congress under which you lost that battle, I believe, in ‘94, has been filled with critics who said, yes, you've speeded up drug approval process but it's still too slow. I know you feel that you've done as much as you can, but why do you think that there is still that criticism there? I mean, surely these members of Congress don't want you to approve unsafe drugs?

DR. DAVID KESSLER: How long do you think it takes us to approve a drug for AIDS, or a drug for cancer?

MARGARET WARNER: Tell us.

DR. DAVID KESSLER: Six months? Seven months? We approved the protease inhibitors in 40 days. What we cared about was making sure that we didn't stand in the way for even one day of getting those drugs to patients who needed them. People say they want to have access and they want to have access today to everything. It's true with dietary supplements, but then what happens when something goes wrong? What do we say? They say, where were you, FDA? You can almost call it the American way. We want it both ways.

MARGARET WARNER: What is your assessment, and have you tried to factor it in terms of what the public wants? Does the public have this kind of ambivalence?

DR. DAVID KESSLER: I think the public does expect from us a high degree of vigilance. The public expects us to be on their side. They expect us to make decisions in their interest, in their interest alone.

MARGARET WARNER: But yet there are times where they say, as you've said, we want the drugs now, government's too overbearing, it regulates too much?

DR. DAVID KESSLER: Yes. They say it, and when you ask your questions, do you want to get government off your backs, do you want to get government out of your lives, people always say, yes, we want that. But then if I ask you what's the role of government in the safety of your foods, what about the safety of the blood supply, what about in finding discoveries in pediatric AIDS? The same majority that will vote to get government off their backs will vote for government intervention in those cases.

MARGARET WARNER: Now how confident are you your legacy will endure? When your resignation was announced, tobacco stock prices soared, and there have been articles speculating that with your resignation the President may, in fact, negotiate some deals with this Republican Congress, either a legislative settlement on the tobacco business, or some sort of reforms of the FDA that would clip the agency's wings.

DR. DAVID KESSLER: I've spoken to the President. I've spoken to the Vice President. They care very deeply about what we have done in tobacco. They're not going to have those regulations watered down.

MARGARET WARNER: So you're absolutely confident of that?

DR. DAVID KESSLER: For the first time in our history an American president has stood up. In the last 30 years since we've known about the hazards of tobacco and literally said enough, we need to do something, and not only did he do it, but as it turned out, the public really did support, and it wasn't just people who don't smoke, the President did this--he won Kentucky. MARGARET WARNER: What is the personal toll of a job like this and all of this controversy for someone like yourself? What's it been like?

DR. DAVID KESSLER: I wouldn't have traded this for anything. It was the most challenging, the most demanding time of--of my life. But look at the--what you can actually do. You go into the supermarket, you pull the can off the shelf, you look at that panel, that nutrition facts panel; you can know what's in the food. Where do you get opportunities to have that kind of impact on the public health?

MARGARET WARNER: What are your plans for the future?

DR. DAVID KESSLER: I'll probably go back to an academic environment.

MARGARET WARNER: All right. Well, I hope it gives you the same satisfaction.

DR. DAVID KESSLER: Thank you.

MARGARET WARNER: Thanks, David Kessler.

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