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SODIUM LABELING, PEDIATRIC DOSING FOR COUGH/COLD PRODUCTS ARE POTENTIAL FUTURE TOPICS FOR OTC ADVISORY CMTE., FDA’s BOTSTEIN SAYS; DOXYLAMINE ISSUE ALSO CITED

Executive Summary

Sodium chloride labeling and pediatric dosing for cough/cold products head a list of potential future topics for FDA's new OTC Drugs Advisory Committee, FDA Office of Drug Evaluation I Deputy Director Paula Botstein, MD, told the committee during the first day of its inaugural meeting Dec. 16-17. Botstein, the former acting director of the new Office of OTC Drug Evaluation, noted that she has "a list of dozens of topics that I would like to have brought to this committee," including "some...broad, over-reaching topics like the one [discussed by the committee on Dec. 17], which is alcohol in drug products." Botstein included sodium labeling and cough/cold pediatric dosing among the broad topics on her list. Botstein also cited animal carcinogenicity associated with OTC ingredients as another problem that could find its way before the advisory committee. "What about a weak animal carcinogen?" she asked hypothetically. "Should it be on the OTC market?" FDA has postponed a ruling on whether the antihistamine ingredient doxylamine should continue to be a monograph ingredient in the antihistamine final monograph published Dec. 9 ("The Pink Sheet" Dec. 14, p. 25). The ingredient was included in the tentative final monograph; however, a rodent study conducted by the National Center for Toxicological Research showed a carcinogenic effect. In June 1991, the issue was taken before FDA's Pulmonary-Allergy Drugs Advisory Committee, which voted that the ingredient is "not likely" to be a human carcinogen. Botstein said that FDA has "many issues of that sort that we have not had good advisory committees to take to." During her orientation presentation to the new advisory committee, Botstein gave several other examples of OTC issues that the agency continues to grapple with including phenylpropanolamine and antihistamine use in cough/cold combination products. "We have a set of quite complex scientific problems that the OTC drug office and the reviewing divisions are all involved in that require some of the most complicated and coordinated of scientific judgments and evaluation," she said. "An example would be evaluating the safety of phenylpropanolamine, which is OTC right now as a diet aid and as a decongestant, and we have been evaluating reports of strokes and cerebrovascular accidents." She noted that FDA's adverse event database "is really a very poor database...constructed from individual reports of events." A "big team" assembled from FDA's pulmonary-allergy, neuropharmacological and cardio-renal reviewing divisions with input from agency epidemiologists is working with the OTC office, she said. On antihistamine use in cough/cold products, Botstein said that FDA consultant Michael Weintraub, MD, "has assembled a whole team of people to evaluate existing data on that." In addition to broad issues, Botstein said that the new OTC committee will be asked to provide their judgment and expertise on Rx-to-OTC switches as well as on "occasional NDAs...for OTC products." She reported that the OTC office has had a number of meetings with companies interested in exploring a switch. "It's just a huge list of interesting drugs that people are exploring and thinking about the possibility of switching over the counter," she commented. However, she said that FDA has "very few requests in-house -- it's fewer than a dozen." Weintraub said FDA is aware of "more than 20 medications" that are being considered for switches based on sponsors that have "indicated a desire" to switch a product and on the products at various stages of review at the agency. In a presentation on FDA enforcement activities in the OTC area, Drug Labeling/Compliance Division Director Richard Chastonay indicated that the agency is taking a look at including anti- wrinkling or anti-aging claims in the sunscreen monograph. As a result, FDA is "probably going to...delay enforcement actions" against companies making such claims until the monograph is published, he noted. Chastonay also said that FDA is rethinking its position on tooth whiteners in response to data that show the products may not fit the statutory definition of drugs.

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