WASHINGTON - FDA Commissioner David Kessler was chastisedThursday by several members of the Senate Labor and HumanResources Committee for failing to come to terms with what manycall an `arrogance of power.'

Kessler testified before the Senate Labor and Human ResourcesCommittee, which is examining legislative and administrativereforms the agency should undertake.

Because Kessler has the strong backing of the White House, his jobappears secure. But the tough questioning to which he was subjectedand his reluctance to deal with the committee members' chargesindicate Kessler's tenure is shaky, industry sources said. Pressure ismounting in Congress for demonstrable proof that the agency isembracing change.

"Kessler's ability to respond to Congressional demands formeaningful FDA reform will be a significant indicator of hiseffectiveness on Capitol Hill, a key measure of the President'sconfidence in him," said Lisa Raines, Genzyme's Corp.'s vicepresident of government relations and chief lobbyist. But if Congressand Kessler's relationship becomes "confrontational, then there isalways some risk he will lose his job."

FDA's `re-invention' plan unveiled on Thursday to shorten reviewprocedures and regulatory burdens on biotech, drug and devicemanufacturers was greeted as a welcome first step. But the committeeindicated a need for the FDA to achieve substantial accomplishmentsto diffuse the groundswell of animosity against the agency in themanufacturing, physician and consumer groups. Repeatedly Sen.Barbara Mikulski (D-Md.) pressed Kessler to acknowledge that theagency is notorious for "having an attitude, for poor management andnit-picking the industry."

When Kessler resisted, Mikulski shot back: "If you fail to develop apassion for change, Congress will roll right over you."

Sen. Orrin Hatch (R-Utah) charged that the "FDA is broken." Amongthe complaints named by Hatch: an agency that sees itself as "judge,jury and prosecutor."

Hatch and Mikulski's comments were echoed by Sen. Judd Gregg (R-N.H.) who charged that FDA's "culture was preventing life-savingtherapies from getting to market." Kessler responded that the "FDAis very committed to approving new products within months notyears. But we are also a regulatory agency and sometimes we have tosay `no.'"

Mikulski said "Congress is not asking you not to abide by the rules.There are rules and there are unwritten rules. What I am talking aboutis an adversarial environment. FDA staffers don't return telephonecalls. The industry feels so intimidated that they do not give names ofoffending FDA staffers for fear of repercussions. There is a strongperception, a persistent pattern that I hear from many sources thatsomething is wrong.

"If the U.S. is going to be part of the global economy, then you haveto be interested in consumer protection but job protection as well,"Mikulski stated.

Concerned that the science of biotech manufacturing had "surpassedthe regulatory framework of FDA," Mikulski asked Kessler what theagency was doing to separate out the regulation of highlysophisticated biotech products from rules designed for crudebiological preparations.

Kessler replied that biotech products "do require special treatment,"but made no mention of planned regulatory changes. Mikulskiretorted that "there is strong sentiment in the drug and biotechindustry that the regulatory change can be made without jeopardizingthe public health." n

-- Michele L. Robinson Washington Editor

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

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