A Food and Drug Administration advisory panel on Tuesday unanimously concluded that oral phenylephrine, the decongestant found in many common cold medications, is ineffective.
Phenylephrine is used in a broad array of over-the-counter medications like Sudafed PE and Dimetapp. The drug brought in nearly $1.8 billion in sales in 2022, according to an FDA briefing document, a number that is likely an undercount.
Phenylephrine is different from pseudoephedrine, which is found in cold medications that are kept behind the pharmacy counter.
The Nonprescription Drugs Advisory Committee voted 16-0 that the drug was ineffective, clearing the way for the agency to potentially remove the drug from store shelves following years of studies that show it has no benefit.
“It’s amazing the amount of dollars being spent on something that really has no efficacy,” said William Figg, a committee member and chief of the National Cancer Institute’s Clinical Pharmacology Program.
The Consumer Healthcare Products Association defended the drug in front of the panel, arguing the FDA has “repeatedly concluded the ingredient is safe and effective.”
“Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. healthcare system,” the group said in a statement, “which is why CHPA encourages the panel to consider the real-world experience and needs of consumers when making decisions that will have such broad implications.”
CHPA also argued that pseudoephedrine is not a sufficient alternative, given the purchase restrictions that prevent its sale on convenience store shelves.
“This poses unequal burdens for consumers living in areas with limited access to traditional retail options based on geography, schedules, or socioeconomic factors,” the group said.
But the advisers were not swayed.
“I feel that this drug in this oral dose should have been removed from the market a long time ago,” said patient representative Jennifer Schwartzott, a member of the committee. “The patient community requires and deserves medications that treat their symptoms safely and effectively, and I don’t believe that this medication does that.”
The FDA did not respond to a request about timing on a decision to potentially remove the product from stores.
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