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This article was originally published in The Tan Sheet

Executive Summary

TRANSITIONAL CLASS OF DRUGS STUDY BY GAO IS UNDERWAY at the request of Rep. John Dingell (D-Mich.), according to a recently released study outline from the congressional research agency. The General Accounting Office's abstract of the study points out that Dingell "requested GAO to review the nature of the legal drug distribution systems in selected countries" focusing on systems that include a "category of drug products available without a physician's prescription but that must be obtained through a licensed pharmacist." Dingell originally asked the Office of Technology Assessment to conduct the study in early 1992. However, because the nature of the study is more in keeping with the GAO's work, that agency has assumed responsibility for the survey. One of Dingell's questions for OTA was whether products are switched from prescription to OTC status more readily or more safely in those countries with transitional classes. GAO said the study will address: "(1) the drug distribution system in selected countries and the proposed system for the European Community; (2) the research that has been conducted related to the development and operation of these systems; (3) the drug classification history of selected drugs within the systems; and (4) the nature and scope of pharmacists counseling on the use of pharmaceuticals." The study will look at systems in Austria, Canada, Denmark, England, France, Germany, Italy, The Netherlands, Sweden and Switzerland. GAO said it will "tentatively" focus on aspirin, cimetidine, codeine, diclofenac, diflunisal, ibuprofen, indomethacin, naproxen, phenylpropanolamine, promethazine HC1, ranitidine HC1, sulindac, terfenadine, and theophylline. The study will be conducted in two phases -- survey and review, GAO reported. "During both phases, the project staff will be conducting interviews with FDA officials and industry representatives, developing an overview of the operation of the pharmaceutical distribution systems, and consulting with subject- area experts," GAO explained. Neither the agency nor Rep. Dingell has formally set a deadline for completion of the study. The concept of a "transitional class of drugs" between prescription and OTC availability (often referred to as a "third class of drugs") has been championed by the independent retail pharmacists group, NARD, and has been supported by a consumer group, The National Consumers League. Representatives from both associations spoke in favor of the idea at the inaugural meeting of FDA's OTC Drugs Advisory Committee in November. The Nonprescription Drug Manufacturers Association has been steadfastly opposed to the idea ("The Tan Sheet" March 8, p. 7).

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