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Radiation in Medicine: A Need for Regulatory Reform
of NRC states with that of Agreement States. In April 1993, the GAO reported that the NRC lacks common performance indicators for inspection backlogs, radiation overexposures, and numbers of violations (GAO, 1993). Because the programs of NRC states and Agreement States use different indicators to measure effectiveness, the report asserts, the NRC cannot determine whether the public in each state is receiving the same minimum level of protection.
Partly in response to such criticism, the NRC amended and clarified its policies for overseeing the Agreement State Program. As of 1995, Agreement States are required to report data on misadministrations in the same form and using the same definitions as those used by the NRC for the Non-Agreement States. In May 1995, a new "Final Statement of Principles and Policy for the Agreement State Program" established a stronger performance evaluation process; it was intended to enable the NRC to take more effective, graduated actions to ensure that the radiation control safety programs of the Agreement States remain adequate and compatible (NRC, 1995). These actions include:
periodically assessing Agreement State radiation control programs against established review criteria;
providing assistance to help address weaknesses or areas within an Agreement State radiation control program requiring improvement;
placing a state on a probationary status for serious program deficiencies that require heightened oversight;
temporarily suspending an agreement and reasserting NRC regulatory authority in an emergency if an Agreement Sstate program experiences any immediate program difficulties that prevent the state from continuing to ensure adequate protection of the public health and safety; and
suspending or terminating an agreement and reasserting NRC regulatory authority if the Agreement State experiences difficulties that jeopardize the state's ability to continue to ensure adequate protection of the public health and safety.
Food and Drug Administration
Biological drugs first became subject to federal premarket approval for safety and effectiveness under the Biologics Act of 1902, and the 1902 act remains basically unchanged to this day. The 1902 act was administered by the Public Health Service until it was transferred to the FDA in 1972.
The Pure Food and Drugs Act of 1906 imposed federal policing of all drugs (including biological drugs) to prevent adulteration or misbranding, but did not include premarket approval requirements. The 1906 act was replaced by the Federal Food, Drug, and Cosmetic Act of 1938, which required premarket notification (but not premarket approval) for the safety (but not the effectiveness) of new drugs (but not old drugs). The 1938 act was supplemented by the Drug