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This article was originally published in The Tan Sheet

Executive Summary

Rx-TO-OTC SWITCHES AND OTC ANALGESIC CLAIMS ARE LIKELY TOPICS for FDA's Nonprescription Drugs Advisory Committee in 1994, Committee Chairman Randy Juhl, PhD, University of Pittsburgh, told the Nonprescription Drug Manufacturers Association annual research and scientific conference in Washington, D.C. on Nov. 18. Juhl did not disclose which OTC switches would be considered by the panel. In addition to Syntex/P&G's naproxen sodium and SmithKline Beecham's cimetidine, which have already been reviewed by the committee, switch applications for Burroughs Wellcome's oral Zovirax (acyclovir) and Merck's Pepcid (famotidine) are currently pending at FDA. The question of whether all analgesic claims currently allowed under FDA's monograph for internal analgesics are appropriate for all OTC analgesic ingredients was an issue for the advisory committee in its review of Syntex/P&G's switch application for naproxen sodium and became a contributing factor in the panel's initial rejection of the switch at the June meeting. Juhl indicated that another probable item for the advisory committee's 1994 agenda is the subject of cold claims for OTC antihistamines, which he characterized as a "leftover" from late Rep. Ted Weiss' (D-N.Y.) FDA oversight. The issue was considered at an April 1992 hearing before Rep. Weiss' House Government Operations human resources and intergovernmental relations subcommittee. Rep. Edolphous Towns (D- N.Y.), who now chairs the subcommittee, has indicated an interest in revisiting the issue ("The Tan Sheet" Sept. 27, In Brief). Asked about the involvement of new drug review divisions in OTC issues, Oncology and Pulmonary Drug Products Division Director Gregory Burke, MD/PhD, said his division would be involved in the antihistamine issue when it goes before NDAC but that the "relative involvement would depend . . . on whether or not the issue comes as part of the monograph process or . . . as part of an NDA supplement." OTC Monograph Review Staff Director William Gilbertson, PharmD, noted in his presentation to NDMA on Nov. 19 that, in addition to the antihistamines issue, FDA plans to "definitely" bring pediatric dosing before the advisory committee "probably sometime in the spring." The Nonprescription Drugs Advisory Committee, Juhl noted, is tentatively set to meet four times in 1994: Feb. 16-17, May 18-19, July 28-29 and Dec. 1-2. In deference to OTC office Director Michael Weintraub, Juhl noted that the committee had a "relatively well laid out plan for the 1994 agenda but . . . we are going to have to start over again now that Dr. Weintraub is back in the saddle." Weintraub suffered a stroke on Sept. 12 and returned to his FDA post during the week of Nov. 15 ("The Tan Sheet" Sept. 20, p. 1).

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