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Executive Summary

FDA's Fertility & Maternal Health Drugs Advisory Committee unanimously voted June 15 to recommend that prescription vaginal fungicides be recommended for Rx-to-OTC switches for the treatment of vulvovaginal candidiasis. The 13-member committee agreed that "vulvovaginal candidiasis can be safely and adequately self-treated by the consumer." The panel concurred in a second unanimous vote that labeling for OTC vaginal fungicides should caution against use in certain patient populations, including women with first Candida albicans infections and those with chronically recurring candidiasis. Other specifics of proposed labeling were not addressed directly. The committee essentially agreed with labeling recommendations presented at the meeting by Schering. Presenting potential labeling for OTC vaginal fungicides, Schering's Douglass Given, MD/PhD, suggested that labeling for candidiasis should discuss the target population for the product. The defining attributes of this population, according to Given, are: short duration of onset mild to moderate symptom severity four or less episodes in a 12-month period no history of drug intolerance or side effects to the specific preparation being chosen patients that are reasonably compliant with the indicated regimen, both dose or duration, and willing to use the formulation that is available and low probability of another serious condition. In addition, Given suggested that OTC use be contraindicated in pregnant patients. The committee agreed that labeling for OTC vaginal fungicides should include a statement that certain patients should not use the product -- namely women who are experiencing symptoms that might be candidiasis for the first time, pregnant women or women with chronic infections. FDA Division of Anti-Infective Drug Products Director Murray Lumpkin, MD, asked if the committee felt use of OTC internal fungicides, by women with first-time self-diagnosed infections would present an "inordinate risk" because of the possible delay in seeking physician-supervised treatment. The committee said the risk was not inordinate. * In a presentation to the committee, Ortho Advanced Care Products' Carol Sampson Landers, MD, asserted that OTC preparations "should be approved by the NDA route, not the monograph route." Sampson Landers contended that the NDA approach to OTC switches would have several "clear advantages" over the monograph approach, including: requirements for adverse drug reaction reporting and reporting of new scientific information; instructions for use; advertising scrutiny by the Federal Trade Commission; and conformance to GMPs. In an opening statement to the committee, FDA Anti-infective Drug Products Division Medical Officer Joseph Winfield, MD, raised the possibility of potential harmful effects from not seeking medical attention as well as possible misuse of OTCs for serious vaginal infections stemming from a misdiagnosis of candidiasis. Both the Schering and Ortho representatives maintained that candidiasis, once experienced by a women, is easy to self-diagnose and is difficult to confuse with other vulvovaginal infections. Given and Sampson Landers also suggested that OTC self-treatment can be taught by physicians and has economic advantages. During the public comment portion of the meeting, consumer activists Judy Norsigian, Boston Women's Health Book Collective, and Kara Anderson, Planned Parenthood Federation of New York City, agreed with the industry speakers that self-diagnosis is relatively easy and that cases of misdiagnoses would lead only to "miminal" problems. However, an outside speaker invited by FDA, Jack Sobel, MD, Wayne State University, maintained that many women would use the product despite cautions on the labeling. A woman probably "would not be dissuaded from trying [an OTC vaginal fungicide] the first time" by a statement on the labeling suggesting a visit to a physician, Sobel said. He also worried that such products would be overused by some patients for essentially self-limiting conditions, such as pruritis. However, Sobel said his "major bone of contention" about an Rx-to-OTC switch was whether patients truly have the ability to self-diagnose a repeat episode of vulvovaginal candiasis, even if it has been diagnosed the first time as candidiasis by physicians. Sobel said that many of the "worst-case scenario" vulvovaginal infection patients in his Detroit clinic are there because of a high rate of physician misdiagnosis. Sobel told the committee he had "serious doubts about the ability of patients to self-diagnose ...partly based on" his experience with physicians who fail to "go to the microscope" to make a confirmatory judgment. * Sobel also suggested that before allowing the products to go OTC, FDA should consider approving a diagnostic kit for home use to accompany OTC vaginal fungicides in order to improve patient diagnosis. The committee dropped from consideration FDA's proposal to consider two specific antifungal agents -- clotrimazole (Schering's Lotrimin line) and miconazole (Ortho's Monistat). A representative from Combe, Inc. suggested in the public comment period of the meeting that the committee also consider nystatin. However, the committee avoided discussing the approvability of any specific antifungal agents for OTC use. Ortho already appears to be jockeying for position in the eventuality that FDA allows OTC marketing of vaginal antifungals. The company received approval late last year for an Rx miconazole product in a new tampon delivery dosage form. FDA has spent considerable time and effort looking at the issue of Rx-to-OTC switches for products to treat Candida albicans vaginal infections -- to date, two OTC agency panels have investigated the switch possibilities. Despite one panel's recommendation to allow OTC marketing, FDA has stood firm on the issue. However, the agency appears to be softening on the OTC switch issue if the NDA route is pursued. In 1982 recommendations on topical antifungals, FDA's Antimicrobial II panel urged OTC use of haloprogin 1%, miconazole 2% and nystatin 100,000 U/g for use in treatment of external feminine itching and superficial skin infections associated with candidiasis. However, FDA, in the preamble to the panel's Topical Antifungal Report ("The Pink Sheet" March 29, 1982, p. 3), said it would not permit an Rx-to-OTC switch for those drugs because it believed "that self-treating the symptoms...without knowing or treating the underlying cause...could create a serious health hazard" and that "infections caused by Candida must be diagnosed in the laboratory; they cannot be self-diagnosed by consumers." Just last year, the agency published its Tentative Final Monograph for OTC Topical Antifungal Drug Products ("The Pink Sheet" Dec. 18, p. 17). In the TFM, FDA dropped the antifungal nystatin from Category I to Category III, noting that "it has determined that treatment of superficial skin infections caused by yeast (Candida) is not an appropriate OTC claim." That decision rejected recommendations made by the Antimicrobial II Panel.

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