Pediatric Cough/Cold “Reverse Switch” Will Not Increase Safety – CHPA
This article was originally published in The Tan Sheet
A potential "reverse switch" of pediatric cough/cold OTC drugs to prescription status would not address concerns about efficacy or misuse of the products, the Consumer Healthcare Products Association says
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Phenylephrine doesn’t meet efficacy bar within “generally regarded as safe and effective” standard for OTC monograph drugs, agency says in briefing prepared for NDAC meeting on 11-12 September. FDA say it is “concerned about avoiding potential unintended consequences with regard to changing the GRASE status of oral PE.”
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.
Natural product marketer Bionorica looks to science to convince parents about the efficacy of natural remedies for children while they become more aware of possible risks associated with OTC cough and cold formulas