Executive Summary

FDA OTC LABELING STUDIES "PROCEDURAL, METHODOLOGICAL FLAWS" CITED BY NDMA in a June 13 letter to the Office of Management & Budget. The Nonprescription Drug Manufacturers Association asks OMB to withhold approval of FDA's proposed consumer label comprehension studies and to deny the agency's request that the office apply an expedited, or "emergency," review procedure to the research project. FDA's planned labeling studies, involving over 2,000 subjects, are intended to evaluate the format changes proposed by the agency in February and gather information about consumer preferences for label design variations ("The Tan Sheet" May 26, p. 4).