After decades, FDA finally moves to pull ineffective decongestant off shelves
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a common over-the-counter decongestant, which the agency concluded last year is not effective at relieving stuffy noses.
Specifically, the FDA issued a proposed order to remove oral phenylephrine from the list of drugs that drugmakers can include in over-the-counter products—also known as the OTC monograph. Once removed, drug makers will no longer be able to include phenylephrine in products for the temporary relief nasal congestion.
"It is the FDA’s role to ensure that drugs are safe and effective," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. "Based on our review of available data and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant."
For now, the order is just a proposal. The FDA will open up a public comment period, and if no comments can sway the FDA's previous conclusion that the drug is useless, the agency will make the order final. Drugmakers will get a grace period to reformulate their products.
