FDA ENFORCEMENT ACTIONS WOULD BE "SEVERELY" HINDERED BY PROPOSED GOP RISK ASSESSMENT REGS, AGENCY OFFICIAL CONTENDS BEFORE HOUSE HEARING ON HR 9

Executive Summary

FDA compliance with proposed Republican risk assessment regulations would "severely impede" the agency's ability to initiate enforcement actions for drugs, medical devices and other products by imposing formal risk assessment requirements on what are currently informal decisions, FDA Deputy Commissioner for Policy Bill Schultz warned at a Feb. 2 hearing on Title III of the "Job Creation and Wage Enhancement Act" (HR 9). The hearing was held jointly by two House Commerce subcommittees: Health and Commerce & Trade.