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OTC BOIL TREATMENTS ARE NONMONOGRAPH UNDER FDA FINAL RULE

This article was originally published in The Tan Sheet

Executive Summary

OTC BOIL TREATMENTS ARE NONMONOGRAPH UNDER FDA FINAL RULE that is expected to be published in the Nov. 15 Federal Register. The final rule, which becomes effective on April 15, 1994, follows the agency's proposed tentative final monograph for OTC boil treatment drugs published in January 1988, which contained no Category I (safe and effective) ingredients. The number of nonmonograph ingredients included in the 1988 TFM is expanded in the final rule "to include all other active ingredients for the treatment of boils, such as benzocaine, ichthammol, sulfur, and triclosan," according to the notice. In the TFM, FDA said it would require clinical trial data demonstrating the "antibacterial . . . drawing action" of these ingredients in order to establish monograph status. FDA concluded in the final rule that no "substantive data" were provided to support the claim. Commerce Drug (now Del Pharmaceuticals) submitted a comment to FDA in January 1989 that included three clinical studies on the safety and effectiveness of benzocaine "in promoting reduction in boil size." The comment also addressed the "usefulness" of the ingredients ichthammmol, sulfur, and triclosan in combination as a boil treatment and the efficacy of ichthammol/sulfur and ichthammol/magnesium sulfate as "drawing agents" in the treatment of boils. FDA determined in the final rule that none of the three benzocaine studies submitted is "adequate" to support the effectiveness of the ingredient to reduce boil size. FDA said the studies were "not designed properly" and were "incomplete in many instances." The agency cited a number of problems with the studies, including inconsistent assessments of boil size both in terms of frequency of examination and accuracy of boil measurement. FDA also said the design of the studies was inappropriate for a combination product, explaining "a four-arm study (to include each component [in the treatment], the combination product, and the vehicle) was needed to demonstrate efficacy." After reviewing data submitted on three other ingredients in combination -- ichthammol, sulfur and triclosan -- FDA said it found that ichthammol and sulfur "possess . . . properties . . . useful in certain inflammatory and bacteriological conditions" in in vitro tests. But because no human clinical studies were submitted for the ingredients, FDA ruled that ichthammol and sulfur have not been shown to be "safe and effective in the treatment of boils." FDA also considered references showing the effectiveness of the "drawing action" of ichthammol/sulfur and ichthammol/magnesium sulfate but determined that "adequate effectiveness data" were not submitted supporting this use of the ingredients. Regarding the ichthammol/sulfur combination, FDA said that "data from well- controlled human clinical studies are necessary to demonstrate safety and effectiveness." However, FDA concluded that the efficacy data submitted on benzocaine for itching and discomfort due to bolls was sufficient for further consideration under the OTC external analgesic monograph. The agency noted that no data were submitted supporting the use of ingredients for the "temporary relief of pain and discomfort of boils" such as camphor, juniper tar, menthol and phenol.
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