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OTC BENIGN PROSTATIC HYPERTROPHY DRUG PRODUCTS

Executive Summary

OTC BENIGN PROSTATIC HYPERTROPHY DRUG PRODUCTS have not been shown to be generally recognized as safe and effective, FDA concluded in a tentative final monograph (TFM) published in the Feb. 20 Federal Register. Specifically, the agency mentioned only the combination of glycine/alanine/glutamic acid. The notice stated that FDA was reclassifying the product to Category III on the basis of data previously unavailable to the OTC Miscellaneous Internal panel. The panel published its report in October 1982, at which time FDA said that if the agency proposed to adopt the panel's recommendations it would "propose that benign prostatic hypertrophy drug products be eliminated from the OTC market effective six months after the date of publication of a final rule." However, FDA said it is now proposing "a monograph that would establish conditions under which OTC benign prostatic hypertrophy drug products would be generally recognized as safe and effective and not misbranded." The agency proposed labeling in the TFM "in the event that new data are submitted to establish 'monograph conditions' for OTC benign prostatic hypertrophy drug products." Product labeling states the indications are "for relief of urinary urgency and frequency, excessive urinating at night, and delayed urination associated with benign prostatic hypertrophy (enlarged prostate)." Noting the panel's concern about the potential for a prostatic malignancy to go undiagnosed, FDA said labeling will include a warning that the product should not be taken unless a diagnosis of enlarged prostate has been made by a doctor, and a recommendation for periodic reexamination by a doctor. FDA said two responders to the panel report submitted a total of nine published studies as evidence of the safety and effectiveness of benign prostatic hypertrophy products. The agency stated that "details about study design, conduct, and analysis of the studies are lacking and, therefore, the available data and information cannot be used to establish effectiveness." For example, FDA said, "the study by Feinblatt and Gant lacks information regarding evaluation of the effectiveness parameters so that the question of bias cannot be eliminated. In addition, the blindness of this study is compromised by assigning different treatment times for the drug group (three months) and the placebo group (two months)." FDA further stated that "in the Damrau study, no placebo group was employed; the results of this study were compared to the placebo results from the Feinblatt and Gant study." The agency asserted that "valid conclusions cannot be drawn by comparing the results of the effectiveness parameters monitored with observations made by different investigators in different patient populations." Written comments on the TFM and requests for oral hearing before the commissioner must be submitted to FDA by April 21, 1987. New data may be submitted until April 20, 1988, at which time the administrative record will be closed. Data submitted after closing of the record will be reviewed only after publication of the final rule.
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