The drug regulation process and the challenge of regulatory reform

After 17 years of experience with the far-reaching 1962 amendments to the law regulating new drugs, a major effort is underway to overhaul the law. Important questions of health policy are involved. An extensive recent study by the Department of Health, Education, and Welfare's Review Panel on New Drug Regulation concluded that the system of regulation that requires governmental pre-market clearance of prescription drugs, based on evidence of safety and effectiveness, is fundamentally sound. But the Review Panel identified four principal deficiencies in the drug approval process: a lack of openness and public accountability, an inadequate science environment at the Food and Drug Administration (FDA), imprecision in the standards and procedures for pre-market approval, and limited FDA authority in the post-marketing period. Former FDA commissioner Donald Kennedy took useful administrative steps to mitigate these problems, but legislation is badly needed. Although the bill that recently passed the Senate is not perfect, it contains substantial improvements over the status quo and merits support.