US OTC Monograph Reform's Early Results Could Be Label Orders From FDA, Wait And See For Industry
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.
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Supplement industry’s bullseye on “60 Minutes” after its June segment critical of probiotic health benefits generated the most reads for a US consumer health and overall for HBW Insight articles in 2020. Articles about COVID-19 enforcement actions weren’t as widely read as coverage of FDA’s reorganization in its OTC drug offices and its approvals of additional ingredients to be available OTC.
CDER’s Office of Nonprescription Drugs is “hitting the deck running’” hiring and training staff following passage of OTC monograph reform with user fees to support adding staff and a reshuffling earlier in 2020, says Peter Stein, Office of New Drugs director.
Benefits of OTC monograph reform legislation passed in March likely will take at least several years, according to GAO report to Congress. It notes the FDA still is analyzing the legislation and it may need two years to add and train staff.