The agency said the committee will discuss “whether oral nasal decongestants phenylephrine hydrochloride and phenylephrine bitartrate should be reclassified as not ‘Generally Recognized as Safe and Effective’ due to lack of efficacy.”
The FDA approved the pharmaceutical ingredient in 1976 for nasal congestion, but pharmacy professors Leslie Hendeles, PharmD, and Randy Hatton, PharmD, disagree with the continued approval. The two University of Florida pharmacy professors filed a petition in 2015 asking the FDA to remove the drug from the market, calling it “useless,” CBS News reported March 6.
Dr. Hendeles and Dr. Hatton have published data on phenylephrine that showed it works as well as a placebo, and in 2022, they questioned the FDA’s delayed action.
“Let me be clear, oral phenylephrine is not a safety risk. It just doesn’t work,” Dr. Hatton told CBS News. “I get it. Risk takes priority. But eight years is long enough to wait, you know what I mean? That’s millions and millions of dollars wasted on ineffective drugs.”
The advisory panel is scheduled to meet April 12.
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