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This article was originally published in The Tan Sheet

Executive Summary

OMB CLEARS 14 OTC DRUG MONOGRAPH DOCUMENTS FOR PUBLICATION, an Aug. 9 internal FDA memorandum indicates. Following clearance by the Office of Management and Budget, documents usually are published in the Federal Register within 10 days, barring last- minute changes by FDA. OMB had cleared the monographs as of Aug. 6, the memo notes, adding that FDA's Office of OTC Drug Evaluation will review the OTC drug monograph documents to ensure that no additional updates need to be made. The seven final monographs ready for issuance, according to the memo, include anorectal (live yeast cell derivative) drug products, nailbiting and thumbsucking deterrent products, ingrown toenail relief products, topically applied hormone products, and boil treatment drug products. The memo also lists "topical antifungal drug products" and "topical antifungal drug products (nail and scalp)" as two separate final monographs. Those monographs are the same documents mentioned in a March 12 letter from FDA to Rep. Henry Waxman (D-Calif.). Responding to Waxman's concerns about the sluggish rate of FDA's OTC drug review, FDA had updated the California congressman on the monograph documents that had already been forwarded to OMB ("The Tan Sheet" March 22, p. 1). A proposed monograph for cosmetic products containing hormone ingredients is expected to be published concurrently with the final monograph on OTC topically applied hormone products, the memo indicates. Also slated for upcoming publication are two final amendments to existing monographs -- warning statements required for OTC drugs containing water-soluble gums as the active ingredient and a warning for OTC antacids. The recent OMB clearances seem to have broken a logjam, releasing for publication several final monographs that have been awaited for over a decade. Final monographs for ingrown toenail relief products and nailbiting and thumbsucking deterrent products, for example, have been pending since 1982, when the proposed monographs for those products were issued. A ruling on live yeast cell derivative products also has been anticipated since August 1990, when FDA deferred making a determination on LYCD in its final rule for OTC anorectal products. Whitehall, which manufactures the Preparation H hemhorroid product, has submitted clinical studies to FDA in support of the efficacy of LYCD. Tentative final monographs for topical antifungals and boil remedies were issued in 1989 and 1988, respectively. According to the memo, proposed monograph documents cleared for publication by OMB include: a revised warning statement for antiemetic drug products; a revised warning statement for nighttime sleep-aid products; an amendment to the laxative monograph on docusate salts; and an amendment to the antacid monograph for a revised neutralization test. In its March letter to Rep. Waxman, FDA projected that it would either publish or submit to OMB 67% of the final monographs remaining by the end of 1993 and 80% by the end of 1994. Since then, one final monograph -- for smoking deterrent products -- has been issued ("The Tan Sheet" June 7, p. 15). Forty-two final monographs remain unpublished. Since March, FDA also has issued a final rule removing 415 Category II and Category III ingredients from their respective rulemakings ("The Tan Sheet" May 17, p. 3), a tentative final monograph for sunscreens ("The Tan Sheet" May 17, pp. 10-19), a proposal to amend the dandruff products final monograph to add .6% micronized selenium sulfide ("The Tan Sheet" April 5, p. 8), and a proposal to amend the OTC overindulgence products TFM to include a Reye syndrome warning for bismuth subsalicylate products ("The Tan Sheet" May 10, p. 6).

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