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‘Heretical’ Rule Changes Could Make More Drugs Available OTC In US – Former NDAC Chair Brass

 
• By Malcolm Spicer

Harbor-UCLA Center for Clinical Pharmacology director Eric Brass says FDA should change DFL requirements, considering container labels as part of OTC labeling and reconsidering what information should be included on labels and threshold for consumer comprehension of labels.

OTC drug marketers do “a balancing act” to include necessary information on DFLs without overwhelming consumers with too much while also complying with FDA requirements. • Source: Eric Brass/FDA webinar

As a former chairman and longtime member of the US pharma industry regulator’s advisory committee for approving drugs for nonprescription sales, Eric Brass knows as well as anyone when recommended changes for the agency’s OTC drug label requirements are sharp deviations from current practices.

Brass was candid about the nature of his suggestions during a recent Food and Drug Administration webinar discussing

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