WASHINGTON _ FDA Commissioner David Kessler tendered hisresignation Monday. However, he agreed to remain at his post untilhis successor can be named.

"I have appreciated the opportunity to aid in this public service, butnow believe it is my time to return to private life," Kessler said in awritten statement.

Kessler and the FDA have been the victims of intense criticism forthe last few years, with the drug approval process at center-stage.One of the loudest critics has been Speaker Newt Gingrich (R-Ga.),who said in September 1994 that the agency should be dismantledand replaced byscientific entrepreneurs. Gingrich has called the FDA "the leadingjob-killer in America" and said Kessler was "a thug and a bully."

Many conservative policy groups, which have called for FDA reform,have echoed Gingrich's views, saying Kessler has been at the core ofthe agency's problems.

Kessler's announcement of his intention to leave his post comes inthe middle of intense negotiations between the agency and thebiotechnology and pharmaceutical industries over the reauthorizationof the prescription drug user fee act (PDUFA) as well as just prior toany new legislative efforts on FDA reform.

"You have to give the man credit for being a committed publicservant," said Carl Feldbaum, president of the BiotechnologyIndustry Organization. "I just don't want this interim period to slowdown the progress we are making in PDUFA."

Kessler, a pediatrician and attorney, took over the helm at the FDA in1989. In his statement he said he takes pride in the agency's efforts toimprove food labels, establish mammography standards and reducedrug approval times. His most recent activities in investigating anFDA role for regulating nicotine as well as regulating tobaccoadvertising has drawn the ire of the tobacco lobby.

The Clinton Administration had asked Kessler to stay at the agencyfor a second term. However, Kessler, whom many thought would stayto see the tobacco regulations through court challenges, only agreedto stay until his successor could be put into place. President Clintonsaid in a written statement, "[Kessler's] contributions to improve thehealth of our nation are many and their effect will continue to be feltfor generations to come."

More immediately, Kessler's resignation has sparked speculation inthe industry over who is likely take over and whether the newcommissioner will continue with agency reforms initiated by Kessler.During his tenure, Kessler eliminated the establishment license andlot lease requirements for biologics.

"Under the rubric of reinventing government, Kessler took the firststeps to modernize biologics and put them on a more level playingfield with traditional chemical pharmaceuticals," Feldbaum said."There are still more steps to take, however."

And, those steps may be hampered should a leadership vacuumdevelop while the agency waits for the Senate to confirm a newcommissioner. Realistically, the post could remain unfilled untilMarch given the time it takes for a nominee to make it through Senateconfirmation hearings.

"Our hope is that PDUFA reform can go forward uninterrupted byKessler's lame duck status," Feldbaum said. "He is one toughnegotiator, but ultimately a realist."

In the meantime, given a slight Republican majority, Feldbaumspeculated that whoever is eventually confirmed will "have a firmcommitment to viewing biologics on equal footing with chemicalpharmaceuticals as well as having a firm commitment to upholdingthe standards of safety and efficacy."

Feldbaum said he hopes the industry can offer input during theconfirmation process although he noted that "by no means did theindustry think it had the right to name the new commissioner." n

-- Lisa Seachrist Washington Editor

(c) 1997 American Health Consultants. All rights reserved.