ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Tuesday, November 26, 1996 TAG: 9611260110
SECTION: NATIONAL/INTERNATIONAL PAGE: A1 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: KNIGHT-RIDDER/TRIBUNE
David Kessler resigned as director of the Food and Drug Administration Monday, having firmly inserted himself into the history books for waging war against the tobacco industry.
As usual, he caught everyone by surprise.
Kessler has steered the FDA through difficult times for six years with tenacity, audacity and shrewd political instincts that some critics said smacked of grandstanding.
Public health officials uttered small cries of alarm on hearing of his resignation, while industries including tobacco and medical manufacturers exhaled quietly in relief.
Although Kessler's assertion of the FDA's authority to regulate tobacco overshadows everything else he has done, he has not shrunk from confrontations with the medical industry or hesitated in cracking the FDA's whip - publicly - whenever he felt companies were stepping out of line.
He required more accurate labeling on fruit juices, restricted use of silicone breast implants and didn't hesitate to send in his agents when companies failed to comply with safety regulations.
Kessler, 45, has offered to delay his ``return to private life'' until President Clinton finds a successor. The FDA spokesman, James O'Hara, said Kessler's departure would not affect the agency's putting into effect proposed regulations restricting teen-agers' access to tobacco and tobacco industry advertising.
``David Kessler represents the best that Americans can give in public service to their country - a tireless commitment to better the lives of our citizens,'' Clinton said. ``His contributions to improve the health of our nation are many, and their effect will continue to be felt for generations to come.''
Kessler will also be remembered for overseeing approval of the country's first abortion pill this year and for speeding the agency's approval of new drugs and devices, especially for AIDS and cancer treatment.
But his overall relationship with industry was strained: His critics charged he never did enough to cut through the FDA's bureaucracy. And in an era when public sentiment seemed against government's meddling in people's lives, Kessler enforced FDA's authority and pushed to expand his agency's role.
Sen. Nancy Kassebaum, R-Kan., who has championed the cause of FDA reform, said, ``It is time for new leadership and new direction at FDA, particularly, I believe, in refocusing on the core mission of assuring safe and effective drugs and medical devices in a timely and efficient manner.''
``Truthfully, no, he wasn't the most popular commissioner ever,'' said James Benson, senior vice president for regulatory and technical affairs at the Health Industry Manufacturers Association, an umbrella group that has to do business with the FDA every day.
``Before they pop their champagne bottles, they're going to wait to see who comes in,'' said Benson, who was also a former commissioner of the FDA, about the general reaction to Kessler's resignation. ``It's the devil you know vs. the devil you don't.''
In his job, which paid $115,700 annually, Kessler oversaw almost 10,000 employees and a budget of nearly $1 billion. His duties spanned industries with $1 trillion in annual sales.
By asserting that nicotine is a drug, and that cigarettes are a drug-delivery device, Kessler decreed that tobacco fell under FDA purview. However the current proposed regulations turn out, the agency's right to regulate tobacco is regarded as a pivotal point in U.S. public-health policy.
Scott Ballin, a spokesman for the anti-smoking Coalition on Smoking or Health, said it would be difficult to replace Kessler's leadership. ``He is basically the one who took the political risks.''
In an interview this year, Kessler had mused about his job, ``There is an enormous amount of pounding intensity that's associated with it.''
He said then that he would leave ``when I'm done.'' On what would be a dream job after he left Washington, he said, ``My general sense is you go back to do what you've done before yes, to academia, to a teaching hospital.''
Kessler, who holds dual medical and law degrees from Harvard and the University of Chicago, used to be the director of medicine at Albert Einstein College of Medicine in the Bronx.
``I had no idea he was resigning,'' Einstein spokesman Arthur Oshins said about whether Kessler might return. ``I would know if something was imminent.''
LENGTH: Medium: 85 lines ILLUSTRATION: PHOTO: headshot of Kessler colorby CNB