FDA Proposal Targets Ineffective Decongestant
In a significant step, the U.S. Food and Drug Administration (FDA) has moved to eliminate oral phenylephrine, a popular over-the-counter (OTC) decongestant, from drugstore shelves. The agency issued a proposed order to remove phenylephrine from the list of drugs permissible in OTC products. This comes after an advisory committee review last year determined the drug to be ineffective in relieving nasal congestion. “It is the FDA’s role to ensure that drugs are safe and effective,” stated Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. If the order is finalized, drug manufacturers will have to reformulate products containing phenylephrine.
The FDA’s proposal is open to public comments, allowing drugmakers and consumers to express their views. However, unless new evidence proves phenylephrine’s effectiveness, the FDA is likely to make the order final. This decision could mark the end of phenylephrine in OTC decongestants, reshaping the options available for those seeking quick relief from nasal congestion.
Phenylephrine’s Rise and Scientific Scrutiny
Phenylephrine gained prominence in 2006, following the “Combat Methamphetamine Epidemic Act of 2005,” which moved pseudoephedrine, a key component of Sudafed, behind pharmacy counters to limit its use in methamphetamine production. With pseudoephedrine less accessible, phenylephrine became the go-to OTC decongestant, despite concerns from researchers. In 2007, an FDA panel reviewed phenylephrine’s effectiveness but maintained its approval while calling for additional studies. Subsequent research, including studies by Merck and Johnson & Johnson, found that phenylephrine performed no better than a placebo in treating nasal congestion.
The FDA also reexamined early studies conducted from the 1950s to 1970s that initially led to phenylephrine’s approval. These studies, based on now-outdated measures of nasal airway resistance, offered mixed results. The FDA noted that only two of these studies, both conducted at the same laboratory, supported phenylephrine’s effectiveness, findings that later studies failed to replicate. Recent data further questioned phenylephrine’s impact, revealing that less than 1% of the drug remains active in the body after oral ingestion due to metabolism in the gut.
Industry Resistance and Future Steps
The FDA’s proposal has stirred opposition within the industry. The Consumer Healthcare Products Association (CHPA), which represents manufacturers of phenylephrine-based products, voiced its disappointment in the FDA’s decision. “As science and methods advance, new data should be considered in the context of the full weight of available evidence,” said CHPA CEO Scott Melville. Despite the CHPA’s stance, the FDA advisory committee’s unanimous 16-0 vote against phenylephrine’s effectiveness suggests a consensus within the scientific community.
As the FDA moves forward with public input and considers finalizing its decision, drugmakers are preparing for potential reformulations. Leading pharmacy chain CVS has already announced its plans to remove phenylephrine-only products from shelves. This evolving landscape highlights the FDA’s commitment to revisiting the efficacy of long-standing OTC decongestants and may pave the way for more stringent standards on drug effectiveness in the future.
