WASHINGTON – He holds twin degrees in medicine and economics, converses easily with the nation’s top scientists and can actually understand the scholarly tomes that line the bookshelves of his suburban office.

But when FDA Commissioner Mark McClellan, the man in charge of protecting the public from risky medicines and products, needs a little down-home advice or a break from the pressures of Washington bureaucracy, he reaches out to a familiar and reassuring touchstone: his straight-talking mom, Texas Comptroller Carole Keeton Strayhorn.

“I use Mom as kind of a sounding board,” McClellan said recently during a typically hectic day. “Mom’s not afraid to share her opinions about just about anything we’re working on here in Washington. She’s got a real knack for putting it in plain English.”

For McClellan, 40, family ties provide a leavening touch in helping him perform an immensely demanding job. The oldest of four brothers from a Texas dynasty of professed overachievers, he is perhaps not as well-known as his youngest brother, Scott, 35, who works a few miles away as the top spokesman for President Bush.

But as the 18th commissioner of the U.S. Food and Drug Administration, he has a huge influence on the lives of ordinary Americans, supervising an agency that regulates everything from condoms and microwave ovens to drugs that can stifle a sneeze or ease the onslaught of cancer.

Products governed by the 10,500-employee agency account for 25 cents of every dollar spent by consumers. Consequently, the FDA and the person who runs it are perpetually under scrutiny from the FDA’s vast and diverse constituency, which often accuses the agency of moving too fast or not fast enough, of regulating too much or too little.

McClellan is completing his first year on the job at a time like no other in the agency’s 97-year history.

Soaring drug costs are pushing consumers near rebellion; they’re turning to Canada and elsewhere for cheap imports. Drug counterfeiting has increased fourfold since the late 1990s. Cyberdealers are turning the Internet into what McClellan calls “the 21st century’s virtual drug cartel.”

The threat of terrorism in the aftermath of Sept. 11 has forced the FDA into a realm that would have been inconceivable when President Theodore Roosevelt created the agency in 1906 to stamp out snake-oil salesmen. FDA inspectors staff ports of entry on the lookout for anthrax or poison in imported food. McClellan is the first FDA commissioner to receive classified security briefings.

He was named to the $140,000-a-year post in November 2002 after serving on Bush’s council of economic advisers and as a senior policy adviser on health care.

McClellan got a medical degree from the Harvard-MIT Division of Health Sciences and Technology in 1992, and a year later received a doctorate in economics from Massachusetts Institute of Technology.

His politician mom, though hardly impartial, says her oldest son showed his potential even in infancy. “He knew his alphabet at 18 months, and he was reading at 2,” she said. “I’d be reading stuff to him, and I realized he’d be reading stuff back to me.”

Like his brothers, McClellan was strongly influenced by his grandfather, W. Page Keeton, Strayhorn’s father, dean of the University of Texas Law School from 1949 to 1974. Guided by Keeton’s trademark mantra, “It’s not the dollars you make. It’s the difference you make,” all four brothers excelled in school. Twins Brad and Dudley, 38, are lawyers, Dudley in private practice, Brad in the Texas attorney general’s office.

Mark McClellan has drawn largely positive reviews and is touted in some circles as a possible second-term replacement for Health and Human Services Secretary Tommy Thompson.

Washington lawyer Peter Barton Hutt, a former FDA chief counsel who specializes in food and drug law, calls McClellan “unequivocally the best commissioner in three decades.” Carol Tucker Foreman, director of food policy for the Consumer Federation of America, gives McClellan favorable marks for antiobesity initiatives and other causes supported by her group.

But Dr. Sidney Wolfe, who heads Public Citizen’s Health Research Group, said McClellan is “doing a terrible job.” He accuses the commissioner and his agency of siding with the drug industry and allowing drugs to remain on the market despite evidence that they cause death or injuries. Serzone, an antidepressant cited by Wolfe’s group, has been blamed for causing liver damage resulting in death.

McClellan, interviewed in his office at the FDA’s 18-story headquarters in Rockville, Md., said he is committed to ensuring that drugs are safe, effective and affordable. He acknowledged the public outcry over rising drug costs and said the FDA is trying to do its part to curb costs by making the agency’s approval process more efficient and expanding the availability of cheaper generic drugs.

Congressional passage of Bush’s bill to provide prescription drug coverage for 40 million Medicare recipients would lessen the backlash over drug costs, McClellan said. He said consumers are exposing themselves to serious health risks by turning to Canada and other countries in search of cheap drugs, but he understands their frustration.

“They should be angry that they’re being forced to choose between safety and affordability,” he said. “But I’d tell them to be cautious. Because once you go outside of our regulatory umbrella, when you’re buying from another country, there are gaps. There is no regulatory authority to help make sure that the drug is safe. It really is a buyer-beware situation.”

McClellan lives in Washington with his wife, Stephanie, a former Keller resident and Texas Christian University graduate, their 5-year-old twin girls and two cats, Thelma and Louise.

McClellan said that when he is pondering an FDA decision, he never hesitates to seek advice from the legions of scientists in the agency.

“But for more general guidance – what’s the right philosophy, am I staying on an even keel? – I really turn to family for that,” he said. “My wife, my mother, Scott and the standards my grandfather set.”

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(c) 2003, Fort Worth Star-Telegram.

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PHOTOS (from KRT Photo Service, 202-383-6099): Mark McClellan

AP-NY-11-23-03 0605EST