FDA chief announces resignation Stormy 6-year tenure has included efforts to regulate tobacco

Personal reasons cited

Kessler says he'll stay in the top post until successor is appointed


WASHINGTON -- Dr. David A. Kessler, the Food and Drug Administration commissioner who has fought for the regulation of tobacco, worked to standardize nutrition labeling and taken steps to speed the federal drug approval process, has decided to resign after six tumultuous years at the agency, FDA officials said yesterday.

Kessler said in an interview that he was stepping down for personal and family reasons and because he felt he had completed the work he had hoped to do at the agency. Appointed by President George Bush in 1990, he was reappointed by President Clinton four years ago.

In accepting his resignation, Health and Human Services Secretary Donna E. Shalala said: "David is what you hope for in a public servant. He actually improved public health."

But she said she had hoped Kessler would stay in the post while congressional efforts to reduce the agency's authority in an array of areas, including drug approval and food inspection, were under way.

But in the interview Kessler said: "I told the secretary that I thought I'd pushed the family as far as I can. There is a time to come and a time to leave. If you look back on what we said we'd tackle, we've been focused." He said he would remain in the post until a successor was found.

From the point of view of public health advocates, Kessler's six years have been a success. "He is the single most important FDA commissioner, a public health giant," said Matthew Myers, PTC the executive director of the National Center for Tobacco-Free Kids. "He revitalized a moribund agency, and by moving the FDA into tobacco, he may be responsible for saving more lives than any other official in the last quarter decade."

But in the process Kessler also made enemies, not just in the tobacco industry, which has vigorously opposed his efforts to regulate the sale of tobacco as a drug, but also among conservatives who say he favors too much governmental regulation. Some who hailed his arrival at the agency when it was in disarray have since turned against him.

Sen. Orrin G. Hatch, for whom Kessler worked in the early 1980s, became a persistent critic. Earlier this year, the Utah Republican described Kessler to reporters as nakedly political. "If I have a big criticism of David," he said, "it is that he loves publicity and seeks it."

Rep. Joe L. Barton, a Texas Republican, said he thought Kessler's decision was well-timed.

"Dr. Kessler's effectiveness was diminishing," he said. Recently Barton had accused Kessler of overbilling the government for $850 in expenses. The figure may be closer to about $200, the FDA's press office said, but Kessler wrote a check to the government for the full amount.

Kessler said he had no immediate plans, although those who know him say he would be interested in the presidency of a medical school. As soon as a successor is appointed, Kessler said he would spend more time with his children and his wife, who has been pressing her husband to quit his $115,000-a-year job.

When Kessler, who is both a pediatrician and a lawyer and has an advanced business degree, arrived at the agency in November 1990 he was determined to make his mark immediately. He forced Procter & Gamble Co. to back down in a labeling dispute, seizing the company's products from store shelves, an action almost unheard of when public safety is not an issue.

He also created an Office of Criminal Investigation to improve the agency's enforcement capabilities. Kessler wanted to restore the agency's credibility after an advisory committee report in 1990 described an overwhelmed and demoralized staff incapable of coping with increased duties and a bare-bones budget.

Others see his inability to keep dangerous dietary supplements off the market as his greatest failure. Under pressure from the dietary supplement industry, Congress passed legislation to exempt from strict oversight supplements such as ephedra, which has caused several deaths.

On the other hand, the FDA has improved the adverse drug reaction reporting system, information for patients on drug packages and the labeling of over-the-counter drugs. It has also speeded up approval of veterinary drugs.

The agency has tightened mammography regulations and has restricted the use of silicone breast implants to clinical studies until their safety is proven.

Pub Date: 11/26/96

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