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OTA DRUG LABELING STUDY INTERIM REPORT

Executive Summary

OTA DRUG LABELING STUDY INTERIM REPORT: "serious questions" were raised about the adequacy of labeling for 10 of 85 randomly chosen products marketed in Panama and Brazil, according to the Office of Technology Assessment's just-released report on "Drug Labeling in Developing and Newly-Industrialized Countries". The interim report presents findings from preliminary data collected on the marketing of U.S. drug products in Panama and Brazil, as well as observations from field work in Kenya. Summarizing OTA's findings to date, the report states: "Initially, for the 85 products examined, the adequacy of labeling information was not questioned for about ten products. For about 20, the questions raised were considered relatively minor. For about 10, the questions were considered serious. The rest (about 45 products) fell in between." The results reflect determinations made by an expert panel assembled in February to compare the information contained in labeling for Panamanian and Brazilian products with U.S. labeling and other information about appropriate use of the drugs. To assist in the evaluation of the labeling, Arlington, Va. consulting firm Health Information Designs was contracted to prepare summaries of variations in the translated sample of labeling from Brazil and Panama and the labeling of the same or comparable drugs sold in the U.S. The workshop participants then reviewed the summaries, the translated labeling, and U.S. labeling, as well as information in drug evaluation reference books. The group, the report explains, was then "asked to make judgements on which, if any, variations they considered to be `medically important,' those that would have a major effect on prescribing practices or on the health of patients." Drug companies were sent summaries of the panel's comments on labeling of their products and asked to supply medical and scientific support for any variations cited by the group. The interim report notes that two companies, as of November, still had not responded to the summaries and that "until all companies' responses have been received and evaluated, it is impossible to draw any firm conclusions." The preliminary results on the 85 products represent less than half of the total sample of drug products OTA plans to analyze. The complete sample of 183 drug products (103 from Panama and 80 from Brazil) was generated by randomly choosing one product from each therapeutic category marketed by each U.S. company in the two countries. In total, OTA gathered data on 950 products marketed by 19 pharmaceutical firms. OTA has predicted that a draft version of the final report should be available by the spring of 1989. OTA's analysis of labeling information for U.S.-based products in Kenya will be included in the final report. The interim report, which contains only conclusions from anecdotal information, says that OTA was "told by government officials and by several people in the private sector... that U.S. company products are assumed to be of high quality, and that the information provided in the package inserts is trusted." U.S. companies, the report continues, "were said to be better than or equal to European companies, and the U.S. and European products and information were generally superior to those produced domestically by the relatively young local companies."
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