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OTC switch efficacy data on labeling could create market inequities, Merck exec predicts.

This article was originally published in The Tan Sheet

Executive Summary

Rx-TO-OTC SWITCH EFFICACY INFORMATION ON LABELING would create a competitive advantage for products currently marketed over-the-counter, Merck Regulatory Affairs Director Edwin Hemwall, PhD, maintained Feb. 16 at an Institute for International Research meeting in New York City on Rx-to-OTC switches. Hemwall said that requiring OTC switch products to include efficacy data as a part of labeling establishes "competitive inequities for those of us that are coming out with the new switches" because older, currently marketed OTC products "don't have to do this."
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