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OTC HYDROCORTISONE 1%: FDA PUBLIC MEETING URGED

Executive Summary

OTC HYDROCORTISONE 1%: FDA PUBLIC MEETING URGED by the American Academy of Dermatology in April 30 comments to the agency. The association asked that "a public hearing be held before the Commissioner of the Food and Drug Administration prior to any decision changing the status of hydrocortisone." Such a hearing should fully address potential problems associated with marketing and use of the product, the association said. Calling the Rx-to-OTC switch of the higher strength hydrocortisone "controversial," the academy said its members "are particularly concerned about consumer self-diagnosis and self-administration of the drug...The potential [for] serious deleterious side effects of indiscriminate and unsupervised consumer use" of 1% hydrocortisone "is a very real hazard and is further exacerbated by commercial inducements for inappropriate marketing and advertising," according to the AAD. In other comments on FDA's Feb. 27 proposal to switch 0.5-1% hydrocortisone to OTC status, Dermick Labs warned that use of the more potent strength without medical supervision could be hazardous. The Rorer subsidiary, based in Blue Bell, Penn., markets a line of prescription 1% and 2% hydrocortisone products under the brandname Hytone, as well as a 0.5% OTC version of Hytone. Dermik maintains that "a number of the proposed indications for OTC 1% hydrocortisone are not readily self-diagnosable, e.g. eczema, sebhorrheic dermatitis and psoriasis." Consumers diagnosing themselves have been known to apply hydrocortisone to fungal infections, skin lesions, urticaria, syphilis, and other conditions where the application of hydrocortisone is useless or harmful, according to the company, which suggests that without a doctor's supervision the higher strength poses a greater risk of damage than the current OTC strengths of 0.25-5%. Dermik has also sent letters to dermatologists explaining its opposition to the switch and stating that "Dermik is concerned that the OTC marketing of 1% hydrocortisone would not be in your patients' best interests." A number of dermatologists submitting comments to FDA in opposition to the switch mentioned Dermik's letter. In earlier comments on the proposed Rx-to-OTC switch, Combe, another OTC hydrocortisone manufacturer, petitioned FDA to allow only 1% hydrocortisone as an OTC strength ("The Pink Sheet" April 23, T&G-7). Combe's argument that the 1% strength is "the lowest effective dose" for hydrocortisone is echoed in an April 27 submission to FDA by University of London dermatology expert Malcolm Greaves, MD, who drafted the British Pharmacopeia's recommendation to allow OTC sales of 1% hydrocortisone in the UK. In support of allowing only the 1% strength, Greaves warns that "the time spent by patients experimenting with cheaper but ineffective low concentration OTC hydrocortisone preparations will delay relief of the skin condition being treated, and also, in the case of a hydrocortisone-unresponsive dermatosis, dangerously delay a decision to seek medical advice." The chief U.S. proponent of the 1% Rx-to-OTC switch, Upjohn, which previously has cited Greaves as an ally in its struggle, protests in an April 27 letter to FDA that "the simultaneous marketing of multiple strengths of OTC hydrocortisone products is medically appropriate...and in the best interests of consumers." Upjohn points to precedent of multiple strength marketing of such OTC ingredients as acetaminophen and to the fact that currently "there are over 13 million satisfied users of hydrocortisone 0.5% products." In a meeting in April, FDA told representatives of the Nonprescription Drug Manufacturers Association that it intended to review all comments submitted on the proposed switch before reaching a decision on when and if OTC marketing of the strength could begin ("The Pink Sheet" April 9, T&G-13). Noting that "revisions in proposed labeling may be indicated based on comments received," FDA warned industry not to begin OTC marketing of the strength without explicit approval from the agency.
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