A Decongestant Debate That Won’t Clear Up
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Christopher G. Smith
April 16, 2026 at 8:36 am
As a retired organic chemist with loads of allergies and a father who was a patent lawyer with connections to the early work on modifying amphetamines to make better decongestants with Smith Kline pharma, I have some important thoughts on the decongestant and other maladies involved with these drug structures and treatments
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John Tellefson
April 15, 2026 at 2:55 pm
I have found that phenylephrine IS an effective medication at 10 mg every several hours. I get bad colds and allergy attacks, and its use is good for me in pills and also nasal mist. I think it’s being attacked because it’s cheap and the Big Pharma firms want to sell the public stuff that’s more expensive with higher markup, instead of the old lower-profit phenylephrine products.
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Randy Hatton ran the hotline. His students fielded dozens of drug-related questions from pharmacists, physicians, and even the occasional vet. When the phones rang, Hatton and his team never knew what to expect. One time, surgeons dropped part of a patient’s skull on the floor and wanted to know what solution would sterilize the bone chunk before they put it back in. Another time, veterinarians called to ask how big of a dose of human antibiotics to inject into an African elephant. But then, Hatton, himself a pharmacist, got a question that sparked a 20-year quest over a seemingly benign drug: a popular over-the-counter decongestant.
Randy Hatton and post-doctoral pharmacy residents at the Drug Information and Pharmacy Resource Center in the 1990s. The hotline fielded dozens of questions from pharmacists, physicians, and even the occasional vet. Calls about Sudafed PE piqued Hatton’s interest.<br>Visual: Courtesy of Randy Hatton
Known as the Drug Information and Pharmacy Resource Center, the hotline had been founded in 1972 at the University of Florida in Gainesville. By the mid-2000s, the center had cubicles and functioned as a 9-to-5 training lab for students. (In an era of dial-up and limited internet access, Paul Doering, the center’s former co-director, said, “We were king of the world because we could find stuff.”) Although practitioners could query online databases like PubMed for answers, when they came up short, they put in a call to the hotline. As such, the center tended to get hard questions.
And that’s how the question that really stuck came in. In 2005, callers began sharing a similar anecdote with students working the hotline: People stopped taking Sudafed, the over-the-counter nasal decongestant that regulators had made more difficult to obtain, and started taking its replacement, Sudafed PE. “They would buy it, and they would take it home,” Hatton said in a phone interview. “And then they’d go back to their pharmacist and say, ‘That stuff doesn’t work. What’s wrong? It doesn’t work.’”
On its face, the reformulation seemed subtle. The packaging looked nearly identical, but the newer version had replaced the key ingredient, pseudoephedrine, with another compound called phenylephrine. Soon, though, it wasn’t just his students trawling databases. Hatton himself wondered why the stuff did not seem to do much in the way of clearing sinuses.
It took far longer than he anticipated to figure it out. What ultimately happened — notably, a series of momentous actions by federal regulators followed by apparent inaction — reveals the onerous path to reverse, or undo, a drug approval.
According to the Consumer Healthcare Products Association, a trade association whose members included nine companies involved in the manufacturing and repackaging of oral phenylephrine, half of all U.S. households rely on oral phenylephrine. The makers of Sudafed publicly maintain that the drug is safe. And the CHPA maintains that the scientific evidence supports the drug as an effective nasal decongestant. In an email, Logan Tucker, vice president of public affairs at CHPA, referred Undark to the association’s formal written comments, which state, “Not every drug is effective for every patient or consumer who uses it.”.
What ultimately happened — notably, a series of momentous actions by federal...