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Study Stirs Doubts On Phenylephrine, Questions On Monograph Process

This article was originally published in The Tan Sheet

Executive Summary

Researchers say “an optimal dose of PE that is safe and produces clinically significant decongestion is still unknown,” and advocates for removing phenylephrine from the OTC monograph say their study is the proof FDA requested.

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US OTC Oral Phenylephrine GRASE Meeting Stretched To Two Days In Rescheduled NDAC

Nonprescription Drugs Advisory Committee will meet online 11-12 September to consider data regarding generally recognized as safe and effective status for oral phenylephrine as a nasal decongestant which have become available since FDA last examined ingredient.

US FDA Postpones Advisory Panel Meeting On Oral Phenylephrine GRASE

Change noted without elaboration in update to FDA announcement on Nonprescription Drugs Advisory Committee meeting. CHPA also notes change, saying it’s best for Industry and for consumers.

Asking Advisors About Phenylephrine Efficacy May Portend FDA Taking Streamlined Monograph Steps

NDAC will discuss whether data supports oral phenylephrine’s GRASE as nasal decongestant. Potential for removing phenylephrine from monograph could be linked to restricting nonprescription pseudoephedrine drugs to behind-the-counter sales since 2006 and overhaul of FDA monograph program authorized in 2020.

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