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Executive Summary

OTC HYDROCORTISONE 0.5-1%: FDA WRITING DERMATOLOGISTS OPPOSED to the proposed Rx-to-OTC switch to request additional information on their clinical observations and to assure them that safety issues have been "thoroughly studied" by the agency. FDA sent at least two such letters to doctors during the first week of May. Since publication of the proposed Rx-to-OTC switch in late February, FDA has received numerous comments from dermatologists opposing the change. Several of the letters appear to have been prompted by a mailing from Dermik Labs explaining its opposition to moving 1% hydrocortisone OTC ("The Pink Sheet" May 7, T&G-7). The agency's response to the individual letters is quick in the context of OTC regulatory proceedings. It may indicate that the agency is trying to take away the incentive for stirring up a grassroots effort against proposed switches. The letters also appear to show an interest in working closely with the professional community on the switch and may reflect the agency's earlier experience in trying to move metaproterenol OTC against a groundswell of opposition from the medical community. FDA also responded to the American Academy of Dermatology's April 30 petition for a hearing on the proposed hydrocortisone switch. The agency told the academy that it needs "more specific information" about the group's concerns over the hazards of 1% hydrocortisone before it can make a decision on the hearing request. "We need you to elaborate on your concerns about consumer self-diagnosis and self-administration of the drug, and about potential serious deleterious side effects that may result from consumer self-use," FDA told the academy May 10. The agency also asked for additional information relating to the academy's concern that hazards would be "further exacerbated by commercial inducements for inappropriate marketing and advertising." FDA noted that it attempted to address those issues in its proposed rulemaking. In other recent comments on the proposal, NDMA urged the agency to publish in the Federal Register an official date on which it will allow interim marketing of 0.5-1% hydrocortisone prior to finalization of the External Analgesics Final Monograph. NDMA objected to the letter from Rhone-Poulenc Rorer subsidiary Dermik. NDMA asked FDA to give "little weight" to anecdotal reports of hydrocortisone adverse reactions not supported by data. NDMA contended that hydrocortisone OTC would be indicated as an antipruritic. "Itching is certainly diagnosable by consumers," NDMA said.

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