HBW Insight

Potential Action By US FDA On Oral Phenylephrine ‘A Lot Harder’ With Old Monograph Program

20 Sep 2023

“We've had several citizen petitions. We can't ignore the data that are out there and are very new since the last time FDA had looked at this back in 2007,” says FDA OTC drugs office director Theresa Michele.

The US Food and Drug Administration is considering the efficacy of oral phenylephrine-containing nasal decongestants with regulatory tools it didn’t have when it asked the same question 16 years ago.

Those tools, delivered in the OTC monograph program overhaul authorized in 2020, make less difficult the agency’s process for potentially...