Kessler steps down from the FDA

January 1, 1997

Pharmaceutical Representative

FDA Commissioner David Kessler, M.D., is leaving after six years at the agency

FDA Commissioner David Kessler, M.D., is leaving after six years at the agency.

At press time, Kessler said he was stepping down for personal reasons and because he believed he accomplished what he set out to do at the FDA. He will officially leave when the White House names a successor.

Kessler was appointed by President Bush in 1990 and reappointed by President Clinton four years ago.

Many public health advocates view the Kessler era as six years of success at the FDA. They say Kessler, a pediatrician and lawyer, revitalized the agency and gave it more clout.

During his first year at the agency, he cracked down on pharmaceutical companies for off-label promotion and led a campaign against confusing food labeling.

In the years to come, Kessler partnered with the pharmaceutical industry to implement user fees that pay for additional drug reviewers. Last year, the FDA reported that it speeded up its drug and medical device approval processes as a result.

He also investigated breast implant safety and took on tobacco companies. In 1994, Kessler announced his plans to try to regulate nicotine as a drug, which would give the government agency authority to regulate cigarettes without legislative action.

Not surprisingly, his zeal for regulation earned him many enemies, particularly in the tobacco industry. He was also a frequent target of Republicans who criticized him for overregulating the pharmaceutical and medical device industries.

Late last year, Kessler was accused of overbilling the government about $850 in travel expenses. The commissioner later wrote a check to reimburse the government for overcharges. Officials said Kessler's decision to resign was not linked to the review of his expense accounts.

At press time, Kessler had not identified his plans for post-FDA life. PR