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Executive Summary

HOUSE VERSION OF FDA COMMISSIONER BILL IS PREFERRED BY AGENCY over a version that passed the Senate Feb. 4. The agency prefers the less detailed language contained in Rep. Waxman's (D-Calif.) bill, which passed the House last spring. Sen. Gore's (D-Tenn.) bill contains a list of specified duties of the FDA Commissioner, which the FDA feels is unduly restrictive. HHS opposes the overall concept of Senate confirmation on the grounds that it is unnecessary. Under the Senate bill, the commissioner's authority includes "providing overall direction to the FDA and establishing and implementing general policies respecting the management and operation of programs and activities of the FDA." The legislation also makes the commissioner responsible for "research relating to foods, drugs, cosmetics, and devices" and for "engaging in educational and public information programs." The Senate bill further stipulates that the commissioner may "establish such technical and scientific review groups as are needed to carry out the functions of the Administration, including functions under the FD&C Act." Early in the Reagan Administration, several FDA advisory committees contained numerous vacancies due to delays as the Office of Management & Budget screened agency nominees to fill those slots. The legislation, which passed both the House and Senate in different forms at the close of the 99th Congress, is also intended to prevent situations where FDA's scientific decisions are overruled by OMB as overly burdensome for industry. Administration critics have said OMB has interfered with FDA decision-making with regard to such regulatory matters as Reye's Syndrome warning requirements for aspirin, color additive regulation, health claims for food, and warning labels for oral, liquid prescription drugs containing aspartame. On the Senate floor, Gore asserted that "the current arrangement has resulted in serious delays that have endangered the public health and cost industry millions of dollars." Under Gore's bill, FDA would be "more independent" but would remain within HHS, unlike the Consumer Product Safety Commission, which is not an agency of the department. The House bill, sponsored by Rep. Waxman (D-Calif.), simply requires Senate confirmation of commissioner appointees. A timetable for a House-Senate conference has not been set.

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