Decongestant Drug Doesn’t Work? Neither Does the FDA

Fall heralds the arrival of pumpkin spice and flannel shirts, and it also brings seasonal allergies and the start of the flu season. Getting the flu and feeling congested is unpleasant enough, but the FDA could soon worsen it.

An outside advisory panel recently presented evidence that the decongestant phenylephrine, found in many over-the-counter flu medications, doesn’t help with congestion. Now, widely used flu treatments like Sudafed, Dayquil, Mucinex and similar products may lose their FDA endorsement as “generally recognized as safe and effective.”

If they do, they could be pulled from the shelves for reevaluation. This is troublesome for two reasons.

First, if the FDA orders these drugs off the market, millions of Americans will be without the medicine they rely on to treat common illnesses and allergies. Nearly half of all U.S. households used a decongestant last year. Several COVID-19 “variants of concern” emerging recently also make it terrible timing to remove any medicines that help treat flulike symptoms.

Second, and perhaps more concerning, is that phenylephrine’s lackluster record as a decongestant is nothing new.

The FDA began asking whether it helped with congestion in 2008. Numerous peer-reviewed studies appearing about a decade ago confirmed it didn’t. So, why is the agency so late to realize and act on this long-known information? And will it now overcompensate and remove products that help millions of patients?

The prognosis is not good.

On average, it takes a new drug between 12 and 15 years to clear the FDA’s long, repetitive and expensive approval process. The same medicines take about three years to get approved in Europe. After a drug is approved in the United States, it undergoes an additional 14 years, on average, of post-market surveillance, where it can be removed from the market even though it was already approved.

FDA removal of drugs and other products from the market after approval is alarmingly predictable. A recent article published in the academic journal Bioinformatics features a model that accurately predicts with more than 50 percent accuracy (an alarmingly high figure in this context) which drugs the FDA will withdraw from the market. Similar models can do the same for contaminated food recalls.

If the agency does decide to order phenylephrine products from the market, it would be far from the first time it overreacted and left patients desolate.

Since 2015, the Owlet Smart Sock helped millions of parents monitor their baby’s oxygen levels and heart rate. Two years ago, the FDA ordered them off shelves for not being formally approved as a medical device. The following year, the United States experienced one of the worst seasons of RSV—a hazardous and potentially deadly virus for newborns. While it’s not to imply the FDA’s decision caused the RSV surge, it’s undeniable that parents lacked a potentially crucial monitoring tool during this crisis.

There are still no commercially available products approved by the FDA to help parents track these vital organ functions.

Last year, a crippling baby formula shortage swept the nation, leading parents to dangerously ration their supplies. At the same time, the FDA refused to amend its 90-day mandatory waiting period or its nutritional labeling requirements to allow foreign formulas into the country. Not even the threat of widespread malnourishment was enough to make the FDA reconsider its approach.

There is no question the FDA should keep phenylephrine products on the shelves. But given its recent decisions to withhold and remove vital products from markets, there is no reassurance it will make the right decision.

That should worry us more than any flulike symptoms.