Rep. Waxman letter to Kessler

Executive Summary

California Democrat tells FDA commissioner in a September letter that he is "concerned" that FDA's Aug. 28 Federal Register notice soliciting comment on the proposed withdrawal of 116 pre- 1986 pending regulations does not contain enough information. Waxman said FDA should "describe the substance" of each reg to provide for public comment and argued that "it is not appropriate to withdraw a proposed rule simply because it is more than six years old and has not been designated 'high priority.'" Instead, each proposal should be considered independently, to be pursued if it has merit and withdrawn if it does not," Waxman wrote. The move to eliminate lingering regs was initiated by new Deputy Commissioner for Policy Michael Taylor ("The Pink Sheet" Sept. 2, p. 13)....