House Republicans to probe FDA's delayed decision on decongestants

Oral decongestants with phenylephrine in the U.S. generated almost $1.8 billion in sales last year, FDA data shows.
Sudafed and other common nasal decongestants displayed at a pharmacy.
Posted at 2:37 PM, Dec 04, 2023

House Republicans plan to launch an investigation into the U.S. Food and Drug Administration’s decision that deemed some over-the-counter decongestants ineffective.

The House Subcommittee on Health Care and Financial Services sent a letter to FDA Commissioner Robert Califf on Sunday requesting a "staff-level briefing" to explain why it took so long to declare the decongestant phenylephrine ineffective, despite earlier evidence suggesting otherwise.

"It is important that the American people have confidence in the FDA’s approvals and trust that the drugs they purchase are not only safe, but also effective," the letter reads. 

Phenylephrine was believed to reduce swelling in nasal and ear blood vessels, and it's a popular ingredient in over-the-counter drugs such as Sudafed, Theraflu, and Vicks DayQuil and NyQuil. However, after a two-day FDA panel review, it was revealed in September that neither the standard nor high oral over-the-counter doses effectively reached the nose to relieve congestion.

Ineffective decongestants could be pulled from shelves, surgeon says
A man sneezes

Ineffective decongestants could be pulled from shelves, surgeon says

Pediatric airway surgeon Dr. Susannah Hills tells Scripps News it's likely products like DayQuil will be pulled from circulation.


According to the House Subcommittee, in the last two decades, pharmaceutical researchers have raised doubts about the ingredient's effectiveness. Despite a previous FDA review approximately 15 years ago and with all available information, the FDA maintained its designation of the ingredient as "generally recognized as safe and effective" (GRASE) for nearly fifty years, allowing its over-the-counter sale.

“It is concerning that the NPDAC, and thereby the FDA, relied upon outdated and insufficient evidence regarding phenylephrine’s use as a decongestant for so many years, despite numerous appeals by the scientific community. Americans seeking OTC relief should not have to worry whether they are wasting their hard-earned money on ineffective drugs," Subcommittee Chairwoman Lisa McClain said in a press release.

Last year alone, oral decongestants with phenylephrine in the U.S. generated almost $1.8 billion in sales, FDA data shows. 

Currently, phenylephrine is considered safe, but without effectiveness, it can't meet the full GRASE designation. This designation lets drugmakers use an ingredient in OTC products without an FDA application. If the FDA decides to pull the designation, it would require companies like Johnson & Johnson and Bayer to reformulate or remove their products from shelves. So far, only CVS has pulled medicines that contain phenylephrine as the only active ingredient from its shelves.

Lawmakers have requested the FDA to schedule a briefing no later than Dec.11.