THE COMMISH UNDER FIRE

By LEON JAROFF

WHETHER OR NOT FDA COMMISSIONER DAVID KESSLER decides to approve olestra, his ruling is sure to be bitterly attacked. That's nothing new for the maverick scientist (and, by training, doctor and lawyer), who in his fifth year as the U.S.'s top health official has achieved a rare combination of public controversy and political longevity. He heads the agency everybody loves to hate, yet he's outlasted most of his predecessors.

In a city where bureaucrats fear their own shadows, Kessler is an anomaly. He seems to make decisions not for political expediency but because he sincerely believes he is doing right. In the process, he has amassed a list of powerful foes that would make lesser men pack up and leave town. He has enraged the tobacco industry, the vitamin industry and the medical-device industry. A self-described Republican, he has alienated most of Congress's Republican majority, including Utah Senator Orrin Hatch, his former boss and mentor. Speaker of the House Newt Gingrich has called him a "bully" and a "thug" and accused him of using "Stalinist" tactics to get his way.

Get his way Kessler usually does. The FDA's scope is extraordinary, ranging over $1 trillion worth of products, from breast implants to orange juice. In one 10-day period last month the agency approved a new aids drug, issued new rules on seafood safety, approved the first treatment for Lou Gehrig's disease and banned nighttime laser shows in Las Vegas.

A former pipe smoker, Kessler has boldly pursued the regulation of tobacco as an addictive drug and has been particularly critical of cigarette ads aimed at children (he calls smoking a "pediatric disease"). One of his proudest achievements was making sure every item of processed food clearly lists its fat, fiber and calorie contents. "The nutrition facts labels changed literally every product in the supermarket," Kessler says. "You used to walk in and not know what to believe."

Yet Kessler's agency is most often criticized not for its actions but for its inaction--for letting the approval process for new medical advances drag out for years and even decades. Virginia Republican Thomas Bliley, the pro-business chairman of the House Commerce Committee, ridicules the FDA's drug-approval procedures as "paralysis by analysis." The Washington Legal Foundation, a vociferously antiregulatory group funded by conservative organizations and companies, has relentlessly attacked the FDA through lawsuits, press releases (sometimes printed on lurid pink and purple paper) and a series of vitriolic print ads. "If a murderer kills you, it's homicide," one declared. "If a drunk driver kills you, it's manslaughter. If the FDA kills you, it's just being cautious."

But delays and cautiousness were FDA hallmarks long before Kessler arrived. His defenders say he has made every effort to speed things up. Even while acknowledging that some approvals still take too long, Kessler points out that the time it takes the agency to okay a new drug is about 19 months, down from 33 months in 1987. In fact, the FDA's responsiveness to aids and certain life-threatening diseases has surprised some early skeptics. Five of the six antiviral drugs used to treat AIDS were first approved in the U.S. The anticancer drug Taxol, the first multiple sclerosis drug and the first cystic fibrosis drug all got the FDA go-ahead long before they were accepted for use in Europe.

Kessler's critics are not impressed. They say that by focusing on the 17% of new drugs that are targeted for deadly diseases, the FDA has stalled the other 83%. "They're terrified of Nader and the left wing," says Senator Hatch, who parted ways with Kessler after a fight over regulating the vitamin industry, which is well established in Utah. "They want zero risk, and there's no way for there to be zero risk in anything." Representative Bliley, a tobacco-industry ally, goes further. The FDA's true mission, he has said, should be "to bring safe drugs and devices to the American people as quickly as possible."

Kessler agrees--to a point. "This is a debate about the legitimate role of government in protecting public health," he says. "Ask the American people if government should be off the backs of business, and you will get a resounding 'Yes!' But ask a more specific question about the role of government in ensuring the safety of the blood supply, or the safety of vaccines, or the safety of food, and you will get a different answer. The public expects us to be vigilant and ask the tough questions when something is about to be added to the food they or their kids eat."

--By Leon Jaroff. Reported by Hannah Bloch/Washington

With reporting by HANNAH BLOCH/WASHINGTON