FDA panel says ingredient in popular oral decongestants is not effective

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The main ingredient in popular oral decongestants doesn’t seem to work, advisers to the Food and Drug Administration said Tuesday in a unanimous vote that could result in removals of the products from store shelves.

The substance in question, phenylephrine, is found in Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion. It became the ingredient of choice in over-the-counter medicines after pseudoephedrine was moved behind the counter in 2006 because it could be processed into methamphetamine, or meth.

The panel made its decision after years of doubt about phenylephrine. As far back as 2007, a team from the University of Florida said the drug did not outperform placebos in cold-and-allergy studies.

“I think the evidence [is] pretty compelling that this medication is not effective and really can’t be effective,” Susan Blalock, a retired professor at the UNC Eshelman School of Pharmacy and adviser on the Nonprescription Drugs Advisory Committee, said Tuesday.

She was among 16 advisers who said trial data and pharmacokinetics, a branch of science that studies the movement of drugs in the body, brought them to a clear conclusion about the oral drugs.

The panel looked at multiple studies that showed no benefit from the oral drugs over placebos.

Advisers also looked at the original data that supported over-the-counter use in the 1970s and decided it did not meet modern standards.

“At this point, I think enough studies have been done. I don’t believe that additional trials would produce a different outcome. I feel that this drug in this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, a patient representative who sits on the advisory panel.

Other advisers said it would be unfair and potentially dangerous to let consumers continue to spend money on drugs that don’t work, especially if they have alternatives.

An FDA presentation said the products under scrutiny generated $1.8 billion in sales last year.

“Utter waste of your money. I have used them myself and felt some relief, but [it] could all have been placebo effect or just cold weakening naturally,” said Arthur Caplan, director of the division of medical ethics at the New York University Grossman School of Medicine.

He predicted that the products would be taken off the shelves because the risk of side effects outweighs any benefits.

The FDA will decide whether to accept the panel’s recommendations. Approval could force consumers to pivot to pills sold behind counters or other forms of phenylephrine drugs, such as nasal sprays.

“If the FDA accepts the panel’s findings, then the logical step would be for the agency to pull these drugs from the shelves of pharmacies and other outlets,” said Lawrence Gostin, a global health law professor at Georgetown University. “It would be a huge step, and the FDA is likely to confront a fierce and well-funded lobbying campaign from the manufacturers of these drugs.”

The Consumer Healthcare Products Association, a trade group representing drugmakers, objected to the vote and said previous trials and regulatory determinations supported oral phenylephrine, or “PE,” as safe and effective.

“We encourage FDA, before making any regulatory determination, to be mindful of the totality of the evidence supporting this long-standing OTC ingredient, as well as the significantly negative unintended consequences associated with any potential change in oral PE’s regulatory status,” said Scott Melville, president and CEO of the association. “While we respect the scientific and public process that allows new science to influence health policy and regulations, we are concerned about previous clinical evidence being inappropriately dismissed and discounted.”

Former FDA Commissioner Scott Gottlieb called the decision a “shame” and said it could lead to higher costs because of limited alternatives.

“There was never a belief phenylephrine was as effective as pseudoephedrine, but it was believed to be weakly active when we looked at this question around 2005/06,” Dr. Gottlieb, who served as commissioner under President Trump and worked at the FDA in the Bush administration, wrote on the X platform, formerly known as Twitter. “Now there may be no good, cheap, accessible options for consumers to get incremental relief.”

Mr. Caplan said the episode showed that regulators were too slow to respond to earlier warnings.

He said congressional lawmakers leery of regulation do not adequately fund the FDA and that direct-to-consumer appeals play an outsized role in the U.S. drug landscape.

“Showing efficacy,” he said, “can’t just be left to Madison Avenue and DTC advertising.”