OTC Switch Interest Cooled By Study Costs To Update Safety Data

Firms often are hesitant to prepare Rx-to-OTC switch applications because safety and efficacy data for their products are over a decade old, notes health care consultant Laura Mahecha.

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Pharmaceutical firms get cold feet about potential OTC switches when they consider the costs for studies to update safety data for an ingredient, suggests Laura Mahecha, a health care market consultant for research firm Kline & Co.

During a June 27 webinar, “Key Issues Trending in the US OTC Market,” Mahecha noted that with safety "paramount for switch approval," data from a drug ingredient's initial

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