THE COMMISH UNDER FIRE

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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.