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OTC Monograph User Fees Inspire Wary Support From Industry

 
• By Malcolm Spicer

Executives from OTC drug manufacturers list numerous doubts about the equity and effectiveness of a potential program that would impose user fees on firms that make or market monograph drugs, the vast majority of nonprescription pharmaceutical products.

The OTC drug industry is not unified in support of FDA's consideration of asking Congress to require monograph drug user program fees as some firms have doubts about the potential benefit to manufacturers and consumers.

Speakers from industry trade groups, medical professional associations, consumer and health care advocacy groups, drug manufacturers' organizations and pharmacology experts agreed with Center for Drug Evaluation and Research officials during a public meeting on June 10 that the

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