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FDA ADVISORY COMMITTEE "LINE ITEM VETO" OF OTC MONOGRAPH INDICATIONS

This article was originally published in The Tan Sheet

Executive Summary

FDA ADVISORY COMMITTEE "LINE ITEM VETO" OF OTC MONOGRAPH INDICATIONS for Rx-to-OTC switch candidates was suggested by Nonprescription Drugs Advisory Committee member Louis Cantilena, MD/PhD, Uniformed Services University of the Health Sciences, during a June 28 meeting of the committee ("The Tan Sheet" July 5, p. 5). Cantilena complained that, at a June 1 meeting of the advisory committee addressing Syntex' Rx-to-OTC switch application for naproxen sodium, "we were put in the uncomfortable position of having to ignore the science and allow" an indication that was not supported by the data. Cantilena indicated that a "line item veto" for OTC indications would have been a good option in that situation and would have allowed the committee to make distinctions between those indications supported by the data and claims that were not well supported. During the naproxen discussion, Cantilena had expressed concern that the committee was considering a claim for relief of the common cold when the only relief experienced by patients in the clinical data submission was for headaches and minor aches and pains ("The Tan Sheet" June 14, p. 4). FDA Pilot Drug Evaluation Staff Director John Harter, MD, responded that the indications the committee was asked to review are carried by all OTC analgesics under the monograph, adding that "if we were to put out something labeled differently, it would be viewed as being very clinically significant and it would be promoted in the marketplace as a large difference." Harter concluded that the committee was "stuck with those indications and [would have] to decide whether the data support them or not." A Syntex representative added that "this sort of package of indications was something [FDA] said [it would] let an over-the-counter drug have if it's a general purpose analgesic, and if there is not a reason to exclude something there" ("The Tan Sheet" June 7, p. 5). Cantilena asked OTC Office of Drug Evaluation Director Michael Weintraub, MD, during the June 28 meeting on doxylamine labeling why the agency applies monograph rules to Rx-to-OTC switch applications. Weintraub replied that FDA is "certainly . . . concerned about [the issue] and one that we're discussing internally." He assured Cantilena that "when the time is appropriate," the agency will raise the issue again "for further discussion" by the committee. "I appreciate your frustration and your feeling that you had to close your eyes to information that was presented to you and yet accept it," Weintraub told Cantilena. He acknowledged that "differentiating between the monograph and the switch-type of situation" in evaluating OTC products is an issue worthy of further consideration.
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