The new commissioner of the Food and Drug Administration, David Kessler, is telling confidantes, "I'm not going to protect crooks."
That's not something most federal agency heads have to spell out when they take the job. But the FDA, once known as a tough regulatory agency, has been branded as corruptible. Kessler, 39, is now the medical director of New York's Albert Einstein College of Medicine. When he takes over the FDA next month, it should be something like grabbing the helm of the Exxon Valdez after it hit the reef.Agency morale is low. The FDA has had a stand-in leader for more than 11 months since commissioner Frank Young was forced to resign - a casualty of the generic-drug scandal that occurred under his watch in 1989. Four former FDA chemists testing generic drugs have pleaded guilty to accepting thousands of dollars in illegal gratuities from drug companies. Last month, the former chief of the FDA's generic-drug division, Marvin Seife, was convicted of lying to federal investigators when he denied having accepted meals from generic-drug executives. The FDA's credibility is at an all-time low. The agency is catching heat for prematurely approving life support medical devices. The most recent investigation looked into allegations that FDA agents were using their inside information about drug approvals to play the stock market. A source told us that the investigation came up dry and no report was filed.
Kessler knows that he is stepping into an office where his predecessor was hung out to dry. Congressional investigators knew more about what was wrong with the agency than Young did. He left office mumbling about being betrayed.
One congressional source told us a big concern on Capitol Hill is that Kessler doesn't "get captured" by any bad elements that linger in the FDA. The hope is that Kessler will be savvy enough to do the right thing and restore the FDA's reputation as a protector of the public.
Those who know Kessler think he won't be easily duped. He has privately vowed that he won't put up with any more corruption. He told one friend, "All I want is 15 minutes of Dingell's time."
It would be an interesting 15 minutes. Rep. John Dingell, D-Mich., led the congressional investigation in the generic-drug scandal with the help of Richard Kusserow, the inspector general for the Health and Human Services Department.
Dingell tried to push through a bill in the last session that would have temporarily closed the doors at the FDA to any drug company convicted of fraudulent dealings with the agency. But the bill was defeated and the generic-drug companies dodged the bullet.
Sources told our associate Jim Lynch that Kessler is respected by Democrats and Republicans, but that his political godfather is Sen. Orrin Hatch, R-Utah.Kessler is a former consultant to the Senate Labor and Human Resources Committee, where Hatch is the senior Republican.
Kessler should not walk gingerly into his new office. He should let it be known that there's a new sheriff in town with no tolerance for the old way of doing business at the FDA.