Speculation is swirling over who will replace David Kessler, M.D., as Food and Drug Administration commissioner-and when-after his surprise announcement last week that he plans to step down as America's top public health cop.
For the meantime, though, the situation seems to spell a continuation of Kessler policies, including what critics contend is a too-slow approval process for new medical devices.
Kessler conditioned his resignation upon the Clinton administration first naming his successor. And with plenty of cabinet positions to fill for the second term, several sources said it's unlikely the president will pick a new FDA commissioner until February or later.
The current controversy over tobacco regulation combined with the prospect of FDA reform legislation during the upcoming Congress may further complicate the administration's task of finding a willing replacement.
As a result, Kessler could be on the job well into next year. And if he leaves only after a successor wins Senate confirmation, which is what Senate Minority Leader Thomas Daschle (D-S.D.) said he interpreted Kessler's announcement to mean last week, then Kessler could still be FDA chief when Independence Day rolls around.
Kessler was the first commissioner to undergo Senate confirmation, a requirement implemented after a scandal over FDA favoritism of certain generic drugmakers during the late 1980s. But Kessler, who was nominated by President Bush and once served on the staff of Sen. Orrin Hatch (R-Utah), breezed through confirmation.
That relatively free ride won't be repeated this time, several FDA watchers predicted.
"This Congress is going to look before it leaps," said James Phelps, a Washington attorney specializing in FDA law. "The next commissioner will have his agenda thoroughly vetted."
The next nominee for the job is almost sure to encounter heavy pressure from tobacco-state lawmakers and senators who are unhappy with the FDA's regulatory pace.
While Kessler's timing caught many by surprise, his avowed wish to return to private life after serving as FDA chief since 1990 resonated with some Beltway insiders.
"Six years is a long time for anyone in Washington-especially an FDA commissioner," said Alan Magazine, president of the Health Industry Manufacturers Association, a medical products trade group.
Magazine predicted there would be few changes in FDA policies in the short term. But he hoped a Kessler successor would do more to speed the approval of medical devices. Device approvals have slowed under Kessler's reign, Magazine said. And even though delays have been reduced lately, the improvements have lagged behind those for other regulated products, he said.
Until Kessler's successor can be found-and there seems to be no front-runner-it looks like business as usual at the FDA.
"Dr. Kessler is still very much commissioner, and he intends to keep working until he walks out the door," an FDA spokesman said.