But getting a new commissioner in place is only one of the challenges ahead for the FDA, which regulates a seemingly endless assortment of controversial products including drugs, medical devices such as artificial heart valves and silicone breast implants, and cosmetics and blood.
n The 105th Congress will consider reauthorization of one of the more important pieces of recent legislation governing the agency: the Prescription Drug User Fee Act.
That 1992 law created a system of industry fees that ultimately led to a streamlining of the historically sluggish approval process; without reauthorization, it will expire in September.
n The new Congress is almost certain to revive the extensive FDA reform measures that died in the crush of the 104th Congress. The previous bills, among other things, would have set up a system to let private companies take over some of the responsibility for reviewing new product applications.
n The FDA also will have to go through the annual appropriations battle - including, for the first time, the need to secure funds that would enable the agency to enforce its landmark tobacco regulations.
The prospect of a search for a new commissioner and a protracted confirmation fight has caused a wave of apprehension among industry officials who have watched the agency improve its performance under Kessler.
"They're at a critical juncture right now,'' said Carl Feldbaum, president of the Biotechnology Industry Organization. "I hope the president acts fast'' on nominating a new FDA head.
Clinton administration officials have just begun their search for a successor to Kessler, who announced his intention to leave last weekend.
Inside candidates for the post include deputy commissioners Mary Pendergast, William Schultz and Michael Friedman, a doctor who has reportedly earned high marks in negotiations with industry on the user fee reauthorization. But lawmakers such as Rep. Joe Barton (R-Texas) say that no inside candidate will do, because the culture of the agency needs to be changed.
Each constituency of the agency wants to ensure its needs are addressed. Matthew Myers of the Campaign for Tobacco-Free Kids, for example, believes that any nominee for commissioner should share Kessler's commitment to see the tobacco regulations through. "They can't have come this far only to back down now. ... The president's commitment is too strong," he said.
But Myers acknowledges that any such candidate could run afoul of lawmakers who oppose the tobacco rules. "The question is going to be whether the broad range of special interests who oppose David Kessler will seek to undermine the agency by contesting any nomination of any strong leader," Myers said, adding that the new commissioner might have an easier time than Kessler with Congress "precisely because David Kessler has become the issue for some people."
Once a nomination is made, Senate confirmation is far from assured. "I think that some tobacco state senators would raise some issues with any nominee, either in public or in private," said Peter Teeley, a press secretary and ambassador in the Bush administration who now serves as vice president for government relations of pharmaceutical maker Amgen Inc.
David Beier, vice president for government affairs at Genentech Inc., said that the confirmation process will be telling, and potentially useful. "I think there really is an opportunity for the nomination and confirmation process to produce some kind of consensus on how you go about securing change," Beier said.
Much will depend on which senator takes the chairmanship of the Labor and Human Resources Committee, which will hold the hearings on the FDA nominee and on any FDA reform legislation. Sen. James M. Jeffords, R-Vt., is the most likely successor to retiring Sen. Nancy Landon Kassebaum, R-Kan. But the moderate Jeffords has come under criticism by the more conservative elements of the party, and Sen. Dan Coats, R-Ind., has reportedly been considering a challenge to Jeffords's selection.
Despite uncertainty about the identity of their future boss, agency officials have begun negotiations with business leaders over the reauthorization of the user fee act, widely considered one of the success stories of government-industry co-operation.
The fees have been used to hire hundreds of reviewers, helping the agency speed up drug reviews well ahead of timetables set out in the legislation. FDA officials privately voice fears that any attempt to load the user fee reauthorization with controversial FDA reform provisions might cause the popular measure to falter under its own weight, reversing prior advances.
Some industry officials agree. Though there is attraction among some members of Congress for the simplicity of a single bill, "For the most part, we would keep those two separate," said Teeley of Amgen. "However, we don't control the Congress." Teeley said he had also heard talk of quickly passing a one-year extension of the user fee bill to allow lawmakers time to draft a solid long-term user fee and FDA reform bill.
One way or another, FDA reform issues will come back to the table, Barton said. "We want to move very quickly on FDA reform . ... (Kessler's) resignation creates a window for someone to do a comprehensive reform bill on a bipartisan basis very early in the next Congress."