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OTC TOPICAL ANTIFUNGAL SPEED OF RELIEF/FUNGICIDAL ACTIVITY CLAIMS

This article was originally published in The Tan Sheet

Executive Summary

OTC TOPICAL ANTIFUNGAL SPEED OF RELIEF/FUNGICIDAL ACTIVITY CLAIMS are not allowed by FDA in the final monograph for over-the- counter topical antifungal drugs. Published in the Sept. 23 Federal Register, the final monograph states that "in the absence of supporting data," claims "regarding speed of symptomatic relief and onset of fungicidal activity provided by antifungal drug products are nonmonograph." However, "if scientific data become available substantiating these claims," FDA said, "they may be submitted in the form of a petition to amend the final monograph." The monograph becomes effective Sept. 23, 1994. FDA had received comments on its December 1989 tentative final monograph on OTC topical antifungals that disagreed with the agency's Category II (not safe and effective) classification of claims such as "kills athlete's foot fast," "kills athlete's foot fungi on contact," and "for fast (or speedy) relief of itching and burning of athlete's foot and jock itch." The commenters argued, according to the agency, that speedy relief claims are performance claims "and should be included among the claims acknowledged by the agency to be outside the scope of the monograph." Several commenters on the TFM also disagreed with FDA's conclusion in the TFM that there was no evidence showing that "consumers are mislead [by such claims] or confuse fast symptomatic relief with fast resolution of the underlying condition." Overall, the OTC topical antifungals final monograph is similar to the TFM. All of the topical antifungal ingredients allowed under the monograph are the same as in the TFM: clioquinol, haloprogin, miconazole nitrate, povidoneiodine, tolnaftate and undecylenic acid and its salts. Other topical antifungal ingredients were handled in separate documents. Antifungal ingredients used in diaper rash products, for instance, were all disallowed under a December 1992 final rule, as were antifungals used for the nails and scalp under a Sept. 2 final rule ("The Tan Sheet" Sept. 6, p. 3). Other antifungal ingredients such as salicylic acid were removed from consideration in a May final rule eliminating 415 Category II and Category III (data insufficient to permit classification) ingredients ("The Tan Sheet" May 17, p. 3). In preparing the final monograph, FDA reviewed two studies submitted by Ortho that attempted to demonstrate that miconazole nitrate 2% in a powder dosage form is effective in preventing athlete's foot. The agency determined that the Ortho trials "had a number of defects and are not sufficient to demonstrate the effectiveness of miconazole nitrate 2% for the prevention of athlete's foot." The agency also reviewed 11 published studies submitted by a commenter to support an OTC labeling indication for the topical treatment of superficial candidiasis associated with athlete's foot and jock itch. Currently, FDA allows anticandidal claims in professional labeling only. FDA decided that the studies ultimately did "not provide convincing epidemiological data that Candida or yeasts are a significant problem in cases of dermatophytic infections seen in the U.S." Only three of the I 1 studies dealt with superficial fungal infections in the U.S., FDA explained, and none of the three were "large enough to have epidemiologic value." However, even if species of fungi, yeasts and bacteria are present and cause athlete's foot or jock itch, FDA pointed out that consumers "have no way of distinguishing whether Candida is present and is a causative microorganism." Also in response to comments, FDA determined that "all antifungal combination products are nonmonograph." However, the agency said it "remains receptive to the submission of any new clinical data that would support general recognition of the safety and effectiveness of such combination products." Among labeling changes to the final monograph from the TFM is the shortening of a warning reading, "Do not use on children under two years of age except under the advice and supervision of a doctor," to "Do not use on children under two years of age unless directed by a doctor." The agency also modified directions for use of antifungals indicated for the treatment of athlete's foot, jock itch and ringworm and for the prevention of athlete's foot. For products labeled for the prevention of athlete's foot, FDA added the sentence -- "Supervise children in the use of this product." In addition, the agency clarified that the product's use "once or twice daily" could be at "morning and/or night." Despite comments received on the TFM that suggested that FDA remove suggestions to "wear well-fitting, ventilated shoes and change shoes and socks at least once daily," the final rule retains the statement. For products labeled for the treatment of athlete's foot, jock itch and ringworm, FDA generally streamlined the language proposed in the TFM to make it more concise, and offered manufacturers the option of using the words "clean" or "wash" instead of requiring that labeling instruct consumers to "cleanse skin" before applying the product. The agency also resisted suggestions to remove a statement that the product "is not effective on the scalp or nails" as well as to remove the "wear well-fitting, ventilated shoes" sentence from athlete's foot product labeling. FDA also retained the caveat, "Avoid contact with the eyes" despite suggestions to remove it, noting that "antifungal drugs are usually applied with the fingers, and a consumer may inadvertently touch the eye if not warned to avoid contact with the eyes." FDA also stood firm in its decision in the TFM to delete "pharmacist" from a statement instructing consumers to consult a physician [or pharmacist] if irritation occurs with use of the product or if there is no improvement within four or two weeks, depending on the indication. Although commenters had argued that pharmacists are readily available to consumers who might never consult with a physician, FDA maintained in the final monograph that the situations described are "more appropriately handled by a physician."
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