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OTC HYDROCORTISONE 1% MARKETING WILL BE SUBJECT TO "IMMEDIATE"

Executive Summary

OTC HYDROCORTISONE 1% MARKETING WILL BE SUBJECT TO "IMMEDIATE" regulatory action until FDA lifts its OTC marketing hold, the agency told representatives of the Nonprescription Drug Manufacturers Association at an April 4 meeting. FDA said it would take "immediate action" against "any manufacturer marketing [a hydrocortisone 1% products] OTC before the agency gives an authorization to everyone to do so," according to minutes of the meeting. FDA said it would "most likely" authorize OTC marketing in a "subsequent notice in the Federal Register." "It is important that all companies respect the temporary marketing-hold status and have an equal opportunity to enter the marketplace at the same time," FDA said it told the NDMA representatives." FDA also told NDMA that "early marketing" of an OTC 1% hydrocortisone product "would give the agency the wrong signal and could be detrimental to future proposed switches." FDA published a notice of proposed rulemaking in the Federal Register on Feb. 27 announcing the Rx-to-OTC switch of 0.5-1% hydrocortisone formulations ("The Pink Sheet" March 5, p. 3). However, the notice specified that marketing could not begin until FDA's official okay. The agency reiterated to NDMA that it intends to review all comments on the proposed switch before reaching a decision "as to whether OTC marketing can begin before publication of the final monograph for OTC external drug products." NDMA, which requested the meeting with FDA, told the agency there is "a lot of interest among their member companies as to when OTC marketing would be allowed to begin," the minutes note. FDA will be accepting comments, objections and requests for oral hearings on the Rx-to-OTC switch until April 30. The agency told NDMA it expected that "revisions in proposed labeling may be indicated based on the comments received." However, FDA said "very few" comments have been received to date. Taking part in the discussion from NDMA were association President James Cope and VP-Scientific Affairs William Soller. Representing FDA were OTC Drug Evaluation Director William Gilbertson, OTC Drug Evaluation Deputy Director Gerald Rachanow, Office of Compliance Deputy Director Sammie Young, and Lee Geismar, Chief of the Analgesic, Antiperspirant & Antimicrobial Branch. A member of the British Pharmacopiea, in comments to the OTC external analgesics monograph, provided additional support for the 1% hydrocortisone Rx-to-OTC switch. In a letter to FDA, Malcom Greaves, MD, University of London, said that in four years of OTC marketing in the U.K. there has been no increase in adverse events.
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