Business Talk

FDA’s nonprescription advisors find no efficacy for phenylephrine

This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data. The change, if adopted by FDA, will have huge implications for consumer options and will challenge the FDA to execute a clear communications rollout.

Quick background on nonprescription drug regulation

Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph.

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