Nearly two decades ago, several pharmacists started calling into the University of Florida Drug Information and Pharmacy Resource Center hotline with the same query: Does phenylephrine, a common ingredient in cold medicine sold over the counter, actually work?
One of us, Dr. Randy Hatton, oversaw the call center, which was meant to train pharmacy students on how to respond to questions from health care professionals across the state. It was odd, Dr. Hatton thought, that so many providers in Florida believed the popular decongestant — found in Sudafed PE, some formulations of NyQuil and many other cold and flu treatments — wasn’t working as advertised.
How can an ineffective drug discovered nearly 100 years ago and marketed since the 1930s still be on the market, despite decades of drug experts like us prodding the F.D.A. to do something? It boggles the mind, and worse than that, this is only the tip of the iceberg. This decongestant is like many drugs on the market that don’t really provide relief.
In 1938, Congress passed the Federal Food, Drug and Cosmetic Act, which required that the federal government determine a drug is safe before it could be sold to Americans. More than two decades later, in 1962, breakthrough legislation — the Kefauver-Harris Drug Amendments — required that prescription and over-the-counter drugs must prove to be both safeeffective. As you might imagine, thousands of over-the-counter drugs were on the market before 1962. So the F.D.A.
This is a problem for the F.D.A. because the agency doesn’t have the resources to do the enormous work of studying, evaluating and removing old and ineffective drugs, despite having the mandate to do so. There have been recent attempts to make this better: The Coronavirus Aid, Relief and Economic Security, or CARES, Act of 2020 included the first major overhaul to the O.T.C. monograph process and provided the F.D.A. with more resources, including personnel. But so much more funding is needed.
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