Brittain first FDA panel seismic

Kristy Brittain's first meeting of the U.S. Food & Drug Administration Nonprescription Drugs Advisory Committee (NDAC) was a memorable one. 

At its September 11-12, 2023 meeting, the FDA panel voted unanimously that phenylephrine is ineffective when taken orally, which means a number of over-the-counter medications don't actually work. If the FDA acts on this recommendation, some major drugmakers would be forced to pull their medications from the shelf. 

The world has taken note. The news was reported by the Associated Press, the New York Times, Bloomberg, Reuters, CNN, NBC News, and many others.

“It’s hard to argue with the evidence,” said Brittain, professor of clinical pharmacy and outcomes sciences at the MUSC College of Pharmacy. “They presented information on the most recent research on this issue and the findings were clear.”

The panel of experts from pharmacy, medicine, biostatistics, public health, consumer affairs, and other fields heard presentations from the FDA and the Consumer Health Care Products Association.

Oral phenylephrine, which is found in drugs like Sudafed PE, DayQuil, AlkaSeltzer Plus Severe Cold and Cough, and many others, came onto the market because research had proven some efficacy. But those studies are decades old. Newer studies, using more advanced technology and greater rigor, were conclusive that it is not effective, at least in the oral form.

If the FDA acts on this recommendation, some over-the-counter medications would be discontinued until reformulated. However, Brittain noted that other over-the-counter options, including topical phenylephrine, remain available, as well as behind the counter medications.

“One of the problems with leaving oral phenylephrine on the market is that it is often found in combination products treating multiple symptoms,” Brittain said. “But patients rarely have all of these symptoms at once. Reading the labels and talking to your pharmacist is the best way to make sure you’re taking the right amount of the right thing with many of these products.”