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US OTC Monograph Reform's Early Results Could Be Label Orders From FDA, Wait And See For Industry

 
• By Malcolm Spicer

With much of FDA's work currently focused on the COVID-19 pandemic, the agency has limited resources available to implement monograph changes authorized by recent legislation. Drug firms awaited a monograph overhaul with expectations for success where they previously failed, but they need FDA's guidance to succeed.

Stop Wait Go Glossy Button, Vector illustration

The earliest results of overhauling the program responsible for most OTC drugs available in the US likely will be regulatory orders for label changes for increasing safe use of some products and confusion from firms about navigating the revamped system.

Potential opportunities for adding ingredients, indications and dosage forms to the numerous product categories within the Food and Drug Administration's OTC monograph as well as exclusivity periods for some approved changes drove drug industry support for legislation to streamline the system launched in 1972 that in recent decades became untenable

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