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."
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning