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Executive Summary

Claims for treatment of common cold symptoms will not be addressed in the upcoming final monograph for antihistamines, FDA OTC Drug Evaluation Monograph Review Staff Director William Gilbertson said Nov. 17 at an Institute for International Research conference on Rx-to-OTC switches in New York City. Gilbertson explained that the OTC final monograph for antihistamines, due out "in a couple of weeks," will be "substantially similar" to the 1985 tentative final monograph for antihistamines, but what "will not be in there is the claims for the common cold." The decision not to include claims for treating cough/cold symptoms in the antihistamine final monograph diverges from FDA's previous plan. At an April hearing of the House Government Operations/Intergovernmental Relations Subcommittee, Center for Drug Evaluation and Research Director Carl Peck, MD, noted that there had been "no change" in the status of cold claims in a draft antihistamine final monograph from the tentative final monograph, which allowed the cough/cold indication ("The Pink Sheet" April 13, p. 6). However, Peck emphasized at the hearing that a final decision had not yet been made, and that FDA would take "a careful look at that section of the proposed monograph." FDA plans to bring the issue of cough/cold claims for antihistamines before its newly-created Nonprescription Drugs Advisory Committee at its second meeting, which will be held some time in March. NDAC's inaugural meeting is scheduled for Dec. 16- 17 ("The Pink Sheet" Nov. 16, p. 3). In addition to a one-day orientation, the agenda of the first meeting includes a discussion of the use of alcohol in OTC formulations. Gilbertson told the switch conference that the expected director of the OTC Office, Director Michael Weintraub, MD, "has been working with about four or five physicians" from the National Institutes of Health "on an overall assessment" of the cough/cold claim issue that "we are probably going to take to NDAC in March for one last look." The assessment, Gilbertson said, includes a review of all currently existing data in the literature and in new drug applications for antihistamines. In the meantime, already-marketed OTC products containing antihistamines can "continue to be marketed with the common cold claim," Gilbertson noted, but "no new ones will be approved." He pointed out that Sandoz was not permitted to use the cold claim for Tavist when it was approved for OTC marketing in August because FDA at that time was already anticipating removal of the cough/cold indication for OTC antihistamines. FDA is also expected to remove the asthma warning from the antihistamine final monograph. Current labeling advises asthma sufferers not to use the product unless they first consult with their physicians. The asthma labeling change will be cross- referenced in a separate document that FDA anticipates will also remove asthma patients from the warning lists of other products, such as antitussives and antiemetics. Gilbertson indicated that the antihistamine final monograph will not include doxylamine as an ingredient because of pending studies on its carcinogenicity. In June 1991, FDA's Pulmonary- Allergy Drugs Advisory Committee recommended that doxylamine- containing products should include a warning informing consumers of a study conducted by the National Center for Toxicological Research that associated doxylamine with a high incidence of liver tumors in rats ("The Pink Sheet" June 24, 1991, p. 7). FDA has not yet made a final decision on the matter. Other upcoming documents that FDA expects to issue soon, according to Gilbertson, are an amendment to the antitussive final monograph that will include diphenhydramine, and final monographs on "antifungal and external diaper rash products." The documents are expected out "in about four weeks," he said. In January, FDA also anticipates publishing a notice in the Federal Register that will allow labeling on NDA-approved OTC products to state that the claims are "FDA-approved." Gilbertson also commented on the new OTC advisory committee. Conceding that some FDAers may be "biased" against Rx-to-OTC switch applications, Gilbertson predicted that, with NDAC, "things are going to be more in a public setting" and therefore "there will be less likely chances for biases of one person or another to be involved as much as perhaps they have been in the past." However, other speakers were not so sanguine about the new committee and its impact on Rx-to-OTC switches. Burson-Marsteller Exec VP Wayne Pines suggested FDA has "an inherent bias against switches" that stems from the physician backgrounds of most medical reviewers in the new drug evaluation divisions. Pines pointed out that six of the 10 voting members on the committee are physicians. Pines advised OTC companies to conduct research on the backgrounds of the new committee members "to find out what they published...[in order to] get a sense of where the committee will be heading." Robert Pinco, a partner in the Washington, D.C. law offices of Baker & Hostetler and former head of FDA's OTC drug evaluation effort, agreed that the OTC advisory committee would not necessarily provide a more favorable review of switch applications. Pinco forecast "business as usual" for OTC drug reviews if the advisory committee consults only with new drug advisory committees and review offices. However, "we may have something very viable" if the OTC advisory group seeks the views of pharmaceutical experts from outside the agency, Pinco said. At present, Gilbertson estimated that there are approximately 22 Rx-to-OTC switch candidates pending at FDA, with most at the pre-investigational new drug or "discussion stages." The FDAer noted that, of those, only about "a dozen" are "pretty well along," including two anti-ulcer H[2] antagonists.

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