The advisory committee's vote may trigger an FDA decision to remove more than 250 cough medicine products from the market, or require a reformulation of such items.
The US Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee (NDAC) voted unanimously against current scientific data supporting the clinical effectiveness of 10 mg oral phenylephrine as a nasal decongestant in the second portion of a 2-day meeting today.1
The committee, that which reviewed new compiled data regarding the Generally Recognized as Safe and Effective (GREASE) status of the common over-the-counter cold medicine ingredient, voted 16-0 against the notion of clinical effectiveness from phenylephrine. They additionally voted in majority against additional studies assessing the pharmacokinetics and clinical efficacy of other phenylephrine doses.
As is a common dynamic between the FDA and its expert advisory committees, the agency is now expected to submit a regulatory ruling on the status of cough medicine formulas containing oral phenylephrine marketed to treat nasal congestion. Among the impacted products would be variations of acetaminophen (Tylenol), guaifenesin (Mucinex) and diphenhydramine (Benadryl).
In its coverage of the committee panel, the New York Times reported the decongestant ingredient is present in ≥250 products that comprised approximately $1.8 billion in sales in the last year.2
While the FDA panel still considers the phenylephrine ingredient safe for consumers—and effective when administered via nasal spray—its orally-administered benefit is essentially nonexistent.
“We know that in its current form, in the dosage it’s currently provided, that you have very low systemic exposure,” committee member Karim Calis, director of clinical research and compliance at the National Institute of Child Health and Human Development, said during the meeting. “If we push the dose, it’s possible that you might get additional systemic exposure, but already with that, we already know that we’ll very likely encounter additional cardiovascular effects—just as we do from that entire class of drugs.”
As is common practice in the event of advisory committee votes—especially ones completed with unanimous opinion—the FDA is anticipated to make a regulatory decision. The agency may rule for the removal of impacted cough medicines including oral phenylephrine from the market—which in turn may significant impact Americans’ over-the-counter strategies for managing virus illnesses during this fall and winter season.
Impacted drug makers may also work to update its cough medicine formulas to reflect a removal of oral phenylephrine in the meantime.
The Times additionally reported a possibility of litigious and lobbying efforts to delay any impending FDA regulatory ruling—or inversely, an established grace period between the agency and impacted drug makers to reformulate cough medicine products.
A number of regulatory figures and infectious disease experts weighed on the committee vote Tuesday, including former FDA commissioner Scott Gottlieb, MD. Gottlieb, now associated with center-right think tank American Enterprise Institute, posted on social media his dissent of the decision—noting the previous removal of pseudoephedrine-based nasal decongestant products from over-the-counter markets about 2 decades ago.
“Now cold sufferers may have even fewer accessible options, driving up healthcare costs,” Gottlieb posted. “If FDA expands use of new path created by reform of over the counter drugs to now proactively remove established OTC drugs from market in absence of safety concerns, (we) need a clear process and rationale for how public health is being advanced and unintended consequences mitigated.”3
Other experts including Rajeev Jayadevan, past president of the Indian Medical Association, praised the FDA committee’s review and analysis of the available data to discern such a decision.
“In a clear statement, FDA admits how it got approved in the first place, also predicting some consequences,” Jayadevan posted. “The document is a fine example of self correction without prejudice, the hallmark of true science.”4