Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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The Wall Street Journal - Tuesday, 26 November 1996.
Bruce Ingersoll, Staff Reporter of The Wall Street Journal
Dr. Kessler plans to resign as soon as a successor is named, conceivably by the end of January. He told Vice President Al Gore and other administration officials that he was ready to leave the FDA after accomplishing most of his objectives, including speeding up the approval of new drugs and overhauling the nation's food-labeling system.
In a statement yesterday, President Clinton hailed Dr. Kessler's public service, saying his efforts to improve the nation's health "will continue to be felt for generations to come." Health and Human Services Secretary Donna Shalala, who in a meeting Friday persuaded Dr. Kessler to stay on until a new FDA commissioner could be found, cited in particular his "profoundly positive effect" on children's health issues.
The departure of Dr. Kessler, a politically skilled holdover from the Bush administration, won't be mourned by many congressional Republicans, including House Speaker Newt Gingrich, who once denounced him as a "thug" because of his regulatory zeal.
Dr. Kessler won't be missed by the tobacco and medical-device industries, either. The administration's war on teenage smoking, including restrictions on cigarette promotion and advertising, made Dr. Kessler a household name and a political asset in President Clinton's reelection campaign. As for the medical-device industry, many manufacturers complain that Dr. Kessler went too far in bringing scientific rigor to the FDA's premarket review of new device applications and in limiting the use of certain devices, such as silicone-gel breast implants.
Dr. Kessler, a pediatrician and a lawyer, has been approached by at least one university. Associates say he might like to run a major medical school or a teaching hospital.
Administration officials insisted that Dr. Kessler's impending resignation isn't linked in any way to a congressional investigation of his travel expenses. He has written an $850 check to reimburse the government for overcharges on cab fares and other expenses.
Many food and drug lawyers and consumer advocates said Dr. Kessler succeeded in turning a listless bureaucracy into an energetic enforcer of food and drug laws. "I don't know another six-year period in the FDA's history as full of significant accomplishments" as the Kessler era, said Stuart Pape, a partner in the law firm Patton & Boggs. "Compare the papertiger image the agency had seven years ago with the reality of today -- an agency with teeth, with muscle."
But some critics contend that Dr. Kessler has been too preoccupied with policy and legislative issues, thus has neglected FDA management problems. Washington lawyer Peter Barton Hutt called Dr. Kessler the FDA's "single worst administrator" in decades, and said his departure will offer the agency "a great opportunity to rebuild itself."
Upon taking over the FDA, Dr. Kessler stunned the industry by immediately cracking down on food processors' misleading claims of freshness and on drug makers' promotion of prescription drugs for unapproved uses. He got the pharmaceutical industry to support the enactment of drug-maker user fees, which are used to pay for additional FDA drug reviewers. As a result, approval times for new drugs, especially for cancer and AIDS drugs, have been greatly reduced.
In a statement, Dr. Kessler gave the FDA staff credit for a long list of accomplishments, ranging "from food labels to tobacco rules, from mammography standards to world-record time for drug approvals, from heightened food safety to crackdowns on fraud."
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