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This article was originally published in The Tan Sheet

Executive Summary

COMBE PETITION TO REOPEN EXTERNAL ANALGESIC TFM FOR HYDROCORTISONE DENIED by FDA in a November letter to the company. The letter stated that the agency would instead consider Combe's January 1992 citizen petition "in developing the final monograph." The petition requests that FDA reopen the tentative final monograph to modify the labeling indication and statement of identity requirements for Category I (safe and effective) hydrotocortisone products and include language specific to the use of the ingredient for seborrheic dermatitis and psoriasis. FDA told the company that "the agency considers your comments already in the rulemaking process" for hydrocortisone as an external analgesic drug and that it considers Combe's "petition to reopen the administrative record for the rulemaking process to be unnecessary." However, FDA said, "due to time constraints the agency does not intend to amend" the TFM. Combe had also requested that FDA amend the final monograph for dandruff, seborrheic dermatitis, and psoriasis products with a cross-reference to the external analgesics monograph. However, the agency explained that it could not "include a cross reference in the [dandruff] final rule . . . until the final rule for OTC external analgesic drug products is issued." Combe argued in its petition that "based on the plethora of scientific evidence within the administrative records for the rulemakings" on external analgesics (EA) and dandruff, seborrheic dermatitis and psoriasis (DSDP) drug products and "for public policy reasons, it is clear that hydrocortisone can and should be labeled with a statement of identity and corresponding indications to reflect the fact that such OTC products are "seborrheic dermatitis-antipruritics.'" Combe said that FDA's reopening the rulemaking "would provide the agency with the perfect opportunity to clarify the administrative record." Combe maintained that presently, "OTC pharmaceutical firms are uncertain as to the monograph labeling requirements for hydrocortisone OTC seborrheic dermatitis drug products . . . Nowhere in the analgesic monograph does the agency clearly state what are the necessary labeling requirements." While FDA classified hydrocortisone products as Category I for seborrheic dermatitis and psoriasis in 1990, the external analgesic TFM was not modified to include "a proper statement of identity for these products" or "a complete indication of the drug's use," Combe said. Because FDA decided in 1986 to handle all OTC rulemaking affecting hydrocortisone products under the aegis of the external analgesic monograph, the agency "did not incorporate . . the statement of identity and indications associated with hydrocortisone for seborrheic dermatitis that were originally proposed in the monograph for DSDP products," Combe said. FDA also "omitted a cross reference [in the dandruff monograph] . . . regarding the fact that the EA monograph authorizes and governs the use of hydrocortisone for seborrheic dermatitis," according to the company. "By reopening the record to provide complete labeling conditions, the agency would be promoting fair and equitable marketing practices among competitors" manufacturing OTC seborrheic dermatitis and psoriasis products, Combe contended. In addition, "consumers would be able to adequately compare such products."

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