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IoM contraceptive report questions need for FDA-mandated spermicide efficacy studies.

This article was originally published in The Tan Sheet

Executive Summary

IoM REPORT QUESTIONS FDA's REQUEST FOR OTC SPERMICIDE EFFICACY STUDIES under "actual use" conditions in the agency's tentative final monograph for OTC vaginal contraceptives published in the February 3, 1995 Federal Register ("The Tan Sheet" Feb. 6, 1995, p. 2). As evidence that FDA has become less flexible in the contraceptive area, the Institute of Medicine report says the TFM is "of particular note" because it requires OTC contraceptive manufacturers "to conduct expensive and time-consuming clinical trials and obtain approved NDAs in order to continue to market their products."
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