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Rx-TO-OTC SWITCH CANDIDATES' TRUMP CARD IS PROFESSIONAL LABELING

Executive Summary

Rx-TO-OTC SWITCH CANDIDATES' TRUMP CARD IS PROFESSIONAL LABELING, which can provide a significant opportunity for increasing sales, Proprietary Association Senior VP-Scientific Affairs William Soller suggested at a May 8 Drug Information Association meeting. The challenge for the switch products, Soller explained, will be to communicate those professional label claims to consumers. "The switch ingredients of the future -- cimetidine, ranitidine, naproxen [and the other nonsteroidal anti-inflammatory drugs] that are in the pipeline -- will all likely obtain some sort of professional labeling claims, and the question will be how much of those professional labeling claims can also be given to the consumer," Soller said. "There is no doubt that there is an important marketing benefit that can derive from such an approach for each product that is switched, and there is no doubt of consumer demand for such information," he added. Soller also highlighted the market opportunities for professional label indications for older OTCs, particularly if they are about to face competition from a new OTC or an Rx-to-OTC switch product. Referring to the situation aspirin faced when ibuprofen was entering the OTC marketplace , Soller suggested that aspirin was able to enhance its image and retain some of the sales that might have otherwise been lost to ibuprofen because of the publicity on aspirin's use in the prevention of heart attack. "With the introduction of the newly switched ingredient in a high-spending ad category, consumer interest picks up the new drug's prescription use which is touted -- strength. Here, professional labeling provides a halo effect on the older product and helps raise the sagging image of the older drug facing the competition," Soller said. Because of the uniqueness of the professional label claim, he continued, "the overall sales of the product will be helped despite the decline of OTC sales suffered as a result of the newly switched competitor." Soller emphasized that in both the case of a newly switched OTC and an older drug, it will be important to communicate the professional label claims to consumers. Although FDA's position on promotion of professional label claims to consumers is not completely clear, the agency has endorsed consumer labeling references to professional claims in a number of OTC monographs. In the analgesic tentative final monograph, for example, aspirin manufacturers are allowed to use labeling to instruct consumers to ask their physicians about new uses for the drug.
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