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Executive Summary

Congressional oversight of FDA must be tempered by an understanding of the potential "downside" to criticism directed at the agency, Commissioner David Kessler, MD, said to a Dec. 11 meeting of the Food and Drug Law Institute (FDLI). "I know from my own experience on the Hill that there can be extensive long-term consequences from the way oversight is conducted," Kessler commented, "Criticism often hurts in ways that aren't intended. It can damage the morale of 8,000 FDA employees, and it can damage the FDA's credibility with the public." FDA "cannot recruit the best people from outside FDA -- any more than we can retain the experience and talent the agency already possesses -- in an atmosphere of constant criticism and second guessing," Kessler stated. However, Kessler, who once served on the staff of Sen. Hatch (R-Utah), did not dispute the appropriateness of Congressional oversight: "On Congressional oversight, it's important to remember that I know that world. I welcome the oversight. It's a constitutional responsibility." Sen. Hatch also addressed the FDLI meeting, and agreed with Kessler's assessment: "Congress should conduct proper oversight," Hatch declared. "But there is a line between necessary and desirable oversight, and hearings -- and sometimes some of them are more political grandstanding than they are constructive. I would hope that we in Congress would pursue the former and reject the latter." Kessler used his speech to outline what he considered the six most pressing issues now facing the agency (see preceding story). He discussed oversight as one of two "additional issues" he wished to discuss. The other was FDA's "relatively meager" resources. "It's truly incomprehensible to me, with its current level of funding, how FDA carries out its mission," Kessler said. Kessler stopped short of calling for more resources for FDA, and instead stressed the need for priorities. "Given its rather modest means, FDA must carefully establish its priorities," Kessler said, "I welcome the involvement of the Hill in setting those priorities. The current attitude, however, seems to be something like this: 'Everything is equally important, and FDA must do it all.' This attitude must change. If it does not, if the FDA is required to be all things to all people, then we shall almost surely fail." Hatch, in his address, argued that the agency needs more resources. Because FDA's facilities and salaries are so far beneath the standards of the private sector, the Utah senator noted "it is unrealistic to expect that FDA will continue to attract such talented individuals" as it already has. HHS Secretary Louis Sullivan, MD, commenting on the Edwards Committee's preliminary report at the FDLI meeting, agreed that "FDA must be given a greater share of resources -- increased responsibilities can only be met if we have the tools to do the job." He added that "I would like to commend the President and the Congress for their efforts to bring the resources of FDA more closely in line with its growing tasks." Sullivan's formal written response to the report said only that the secretary "strongly" supported additional resources in "selected areas for FDA."

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