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Executive Summary

FDA's commitment to protecting the interests of a broad consumer constituency will be the guiding principle behind agency policy development, Commissioner Kessler declared in Dec. 10 remarks at the Food & Drug Law Institute's annual meeting in Washington. As FDA balances competing demands, Kessler said that the agency will keep the interests of the public-at-large foremost. The established FDA lobby representing "industry, consumer groups, and other organizations," Kessler said, "need to be in touch with what is going on outside [Washington]. It is these broader forces -- and not insider interests -- that will guide FDA's consumer protection and product review policies." FDA, Kessler continued, is a place where "competing forces converge . . . and as they express their positions on policy matters, they should recognize one thing: arguments based on specialized interests alone are unlikely to carry the day." To the FDLI audience of food and drug law specialists, Kessler pointedly indicated that the agency is wary of the representatives of narrower interests. "It is no secret, especially to the food and drug law community, that people have built careers on fancy footwork to stymie the agency." Kessler said that since becoming commissioner one year ago, "I have been simply amazed -- and I continue to be amazed -- by the attitudes of those who seek remedies outside the FDA," instead of seeking resolution to individual issues through established agency channels. He added: "If we are not able to resolve matters, then of course interested parties may appropriately raise their concerns elsewhere. That is a fundamental premise of our system." The commissioner also defended the agency's prerogative to make its own regulatory/scientific decisions. "We will be politically accountable," Kessler said, "but the political process should not intrude on scientific or regulatory judgments." Kessler's FDLI comments about the agency's commitment to consumer protection are consistent with agency rhetoric that accompanied such highly publicized regulatory actions as crackdowns on food and drug promotional practices. In those and other regulatory actions, Kessler, as a spokesman for FDA, has repeatedly invoked the public good as the basis for action. While that strategy of appealing directly to the public for support of FDA policy has won favor for the agency in the media, Kessler continues to run the risk of upsetting a constituency with access to higher authorities in the Administration. The most noticeable of Kessler's policies since joining FDA last December has been to make the agency's enforcement arm more aggressive, and Kessler told FDLI that enforcement will remain a "top priority." By "emphasizing enforcement in the past year, we have clarified one of FDA's most important goals," he stated. The enforcement policy, he said, has not been for the purpose of "getting everyone's attention," as he said some observers have suggested, but instead "has had everything to do with how we do business." In addition to enforcement, Kessler said, FDA has two other major goals. One will be "getting important new therapies to patients who need them so desperately," and the second is to provide consumers with "the information they need to use products wisely and well" (see related story, p. 7).

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