Critics of the Food and Drug Administration (FDA) have asserted that the agency's process of reviewing new drugs has long been laden with inefficiency and waste and, as a result, new drugs are not made available to consumers on a timely basis. This Note considers the veracity of this claim by examining the history of prescription drug regulation in the United States and the current procedure by which new drugs are reviewed. This Note also addresses the limited extent to which the FDA has interacted with its foreign counterparts in assessing the safety and efficacy of new drugs and the resultant difficulties caused by the FDA's isolationist policies. The Note discusses harmonization, a regulatory reform effort by the FDA and its counterparts in Japan and the European Community, under which pharmaceutical companies need to perform only one set of clinical tests on a new drug to satisfy the testing requirements imposed in the United States, Japan, and the European Community. The Note concludes by addressing the effect that harmonization, if implemented, will have on the major issues involved in the consideration of a new drug for approval, namely the time needed for approval, costs involved in the approval process, and the safety and efficacy of the new drug. The author states that harmonization is a conservative yet vital step in making needed drugs available to consumers in a timely manner and that the perceived weaknesses of harmonization are basically unfounded.
David W. Jordan,
International Regulatory Harmonization: A New Era in Prescription Drug Approval,
25 Vanderbilt Law Review
Available at: https://scholarship.law.vanderbilt.edu/vjtl/vol25/iss3/3