WASHINGTON _ With the impending departure of FDACommissioner David Kessler, the newly-elected Congress will be leftwithout one of the former Congress's favorite icons of regulatoryoverzealousness. Even so, most organizations in the Washington areathat have advocated FDA reform see Kessler serving as a cautionarytale for any reform efforts by the 105th Congress.

Kessler engendered an intense level of personal dislike from manymembers of the Republican-led 104th Congress and served as alightening rod for legislative reform efforts. Some could expect thatKessler's departure would slow the impetus for FDA reform on theHill. However, most policy analysts BioWorld Today interviewed seethe current environment as an opportunity to enact major reformsrather than to ease into complacency.

"We are not disappointed to see Kessler go," said Glenn Lammi,chief counsel of the legal studies division of the Washington LegalFoundation. "But the need for reform still exists. The culture ofcontrol at the FDA was already there before he got there."

Kessler inherited an agency loathe to change and charged with sloth.At the time, the agency was in need of strong leadership to raise itscredibility following the generic drug debacle, but many felt that heexpanded the agency's regulatory authority inappropriately.

"Kessler has done so much to politicize the agency," said JulieDeFalco, policy analyst at the Competitive Enterprise Institute. "And,he has stuck his nose into places where it didn't belong."

Ed Hudgins, director of regulatory studies at the Cato Institute,agreed with DeFalco, noting that "Kessler was the quintessentialregulator out of control."

Both Hudgins and DeFalco highlighted the agency's decision to takesilicone breast implants off the market as an example of Kesslerbowing to the politics of a situation rather than the science. "Kesslertook drastic action when the science wasn't there to prove that theimplants were harmful. It was the equivalent of panic-mongering,"said Hudgins. "And, then he ignored the science when it showed thedevices weren't causing humans problems."

Kessler's attempts to expand the agency's authority to regulatetobacco also raised the ire of many conservative analysts. AndDeFalco called Kessler's recent campaign to prevent tobaccosmoking among children and teenagers "headline-grabbing" anddisingenuous. "Who would say that children should be smoking?"

While Kessler highlighted speedier drug approvals in his writtenstatement on Monday, DeFalco called such statements"disinformation being fed to the public." While the time to approvalmay have lessened, overall development time has lengthened andmany policy analysts blame the FDA's requirements for submittingan application. Lammi noted that the FDA is slow to recognize thehealth effects of inaction.

"Kessler was more concerned about the health and safety of theagency than health and safety of the public," DeFalco maintained.

How the agency should be reformed is still a topic of much debateand will take center stage during the 105th Congress's attempts atreform.

The Competitive Enterprise Institute favors morphing FDA into acertificatory agency that would offer its imprimatur to drugs beingsold rather than regulating which drugs are permitted to be sold. Thatway people could choose to buy only FDA-approved drugs. "Thelarge pharmaceutical houses don't need such changes; they alreadyknow how to work with the FDA," said DeFalco. "But regulationalways hurts the little guy. The small biotech companies and medicaldevice companies who are developing the most exciting products arethe ones that can die during delays in the drug approval process."

Lammi, of the Washington Legal Foundation, noted that the currentrules on review times found in the user-fee legislation need to beenforced, the agency needs to loosen its controls on off-label uses ofthe drugs, and the requirements for submission of a new drugapplication need to be standardized. "We would really like to seesome teeth in the statutory requirements for review times," saidLammi.

The Progress and Freedom Foundation favors third-party reviews andprivatization of the agency's activities in order to "introducecompetitive pressures to the process of review," said Tom Lenard, asenior fellow and director of regulatory studies at the foundation.

Whatever shape FDA reform takes, whoever takes over for Kessler islikely to set the tone for the talks. For this group of conservativeanalysts, Kessler's departure means that an obstacle to such reformhas been removed. However, Hudgins pointed out that Congressneeds to take a serious look at FDA reform so "we don't have anightmare like Kessler again." n

-- Lisa Seachrist Washington Editor

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

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