Dr. David Kessler's specialty is treating sick children. But now he is trying to heal the scandal-sickened Food and Drug Administration.
Kessler, a former aide to Sen. Orrin Hatch, R-Utah, was sworn in this week as the new FDA commissioner - inheriting an agency he admits suffers a lack of credibility with Congress and the public because of generic drug scandals, bribery cases and lapses in regulating health claims on food.Columnist Jack Anderson even recently described Kessler's new job as "something like grabbing the helm of the Exxon Valdez after it hit the reef."
Instead of using the mild bedside manner that he might with a child, Kessler is coming in acting more like a tough cop laying down the law to help restore public confidence.
But Kessler, 39, says he doesn't prefer that role.
"I'm a baby doc. I would love to sit here and talk about new scientific data and therapeutic treatment of children," he told the Deseret News. "Certain docs love to be a Kojak. But not me. But the times may demand it."
For example to help ensure that the agency's enforcement amounts to more than just writing nasty letters, Kessler announced this week he will create a team of 100 criminal investigators over the next two years to investigate violations of the food and drug law.
More tough-cop stances include his talk of pursuing more civil monetary penalties against food and drug violators, obtaining more subpoena power for FDA investigators, requiring inspection of drug production plants and products before their new drugs are approved and possibly creating rules to put extreme violators out of business - called disbarment.
"For companies that play roulette with the safety of the American people, disbarment is not an extreme punishment," he said.
In other words, a new sheriff is in town and he's showing he can be tough.
But he stresses, "It's no secret the entire agency will take up enforcement action a notch. But that's not the only way we fulfill our mission." He said the agency will also seek to better educate the public through new labeling laws and better instructions for use of medical devices.
Many in Congress and health industries say Kessler's unique background may provide the right prescription to fix the agency.
He is both a doctor and a lawyer. He received his medical degree from Harvard and his law degree from the University of Chicago. He looks more like a lawyer, with a neatly trimmed blond beard and a business suit. During press interviews he did not wear the Navy-like Public Health Service uniform that his predecessor preferred.
He has experience in Congress, having worked two years as Hatch's physician adviser on the Senate Labor and Human Resources Committee. That is seen as essential to win confidence there of some key members closely watching every move of the agency.
Kessler said he isn't offended by such close scrutiny. "When the Hill realizes we're strong, it will stop micro-managing us."
Kessler has also been a top administrator of a large hospital - being medical director of the Einstein Medical Center in New York City, which "had a budget roughly the same size as the FDA, even though we only had responsibility for part of the Bronx." Meanwhile, the FDA oversees the safety of one-quarter of all consumer products.
And to help him fall into the category of overachiever, Kessler also taught health law at Columbia University. Kessler is, remember, only 39.
Kessler is also well-informed. At a brown-bag lunch with reporters, Kessler easily answered questions dealing with complicated issues from veterinary drugs to nuclear medicine to the safety of milk supplies.
But Kessler said his agency faces numerous challenges that may make its recovery tough.
For example, he said Congress continues to give it new responsibilities without extra funds - and then complains of delays in such things as approving new drugs for AIDS. Kessler said 21 major bills have passed in recent years adding FDA duties, but they provided little new money.
An example is a new food labeling law passed last year requiring the FDA to develop new rules and standards for food labels within the next 12 months.
Kessler said he will comply with that deadline, but it will "require robbing Peter to pay Paul." He will pull people off other duties to comply - mainly because he feels labeling can help improve nutrition in the nation maybe more than any other step.
He supports more user fees from drug companies and others to help keep the FDA strong, as long as they do not stifle innovation. Kessler should also be helped by some legislation recently passed by Hatch to better computerize and centralize the agency, which is scattered over 23 sites near Washington.
Kessler said he is looking forward to his challenges, and that the biggest surprise of his first week on the job "is how comfortable I feel" with the issues and the job. Even if he prefers treating sick kids, being a tough cop also seems to fit him fine.