The FDA has been evaluating data on the efficacy of oral phenylephrine since 2007. The ingredient was approved for nasal congestion in 1976, but over the years, data has shown it does not help relieve symptoms. In 2015, two University of Florida pharmacy professors filed a petition asking the FDA to remove the drug from the market, calling it “useless.”
If advisors determine oral formulations of phenylephrine are ineffective, the FDA may revoke the drug’s current classification as “generally recognized as safe and effective.”
In briefing documents posted ahead of the meeting, the FDA said it has not identified any safety issues with orally administered phenylephrine products but that it is “concerned about avoiding potential unintended consequences with regard to changing the GRASE status,” noting that oral decongestants with pseudoephedrine are regulated as behind-the-counter products, and consumers may need education on how to obtain them or on what other alternatives are available.
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