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Executive Summary

SENATE CONFIRMATION OF FDA COMMISSIONER would be required under a bill which passed the Senate May 14 as a rider to Sen. Hatch's (R-Utah) Drug Export Reform Bill. Offered by Sen. Gore (D-Tenn.), the amendment was accepted by Hatch without being subjected to a Senate vote. Hatch said he could not "recall an FDA commissioner who would not have been confirmed by the U.S. Senate." In requiring Senate confirmation of the commissioner, Gore's amendment would give FDA statutory authority with greater independence. "FDA would remain under HHS," and "the commissioner would be required to consult with the secty. of HHS" and "would still be subject to dismissal by the President and because of that fact would still be a part of the Administration in a way that purely independent agency heads are not," Gore said. Nonetheless, he continued, "it would be a change, and the principal legal responsibility for administering the various laws given to FDA would be with the commissioner." Consequently, Hatch's Senate Labor & Human Resources Cmte. "would play a larger role in overseeing the activities of FDA," Gore explained. When he introduced his bill earlier this year, the Tennessee Democrat said it would "protect FDA from the taint of bureaucratic infighting" resulting from the Administration's close supervision of the agency. A House version sponsored by Rep. Waxman has passed his Health Subcmte. Full cmte. markup, which had been scheduled for May 15, was postponed. Hatch accepted the amendment despite what he called "fear on the part of a number of others, especially in the executive branch of the govt., who do not want this amendment." The bill "takes the control over FDA away from the assistant secty. for health and places it in a more working relationship with the secty.," Hatch said.

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