Republicans will make Food and Drug Administration officials explain why it took so long to deem a common stuffy nose medicine ineffective despite years of evidence.
Michigan Republican Representative Lisa McClain has spearheaded the effort, giving regulators until December 11 to schedule a visit to the Capitol Hill for an official meeting with House members.
The FDA announced in September that phenylephrine, long used as a decongestant in popular oral medicines such as Sudafed PE Sinus Congestion and Vicks Nyquil Severe Cold and Flu, was no more effective than a placebo at alleviating a stuffy nose.
Drugs that contain it generated almost $1.8 billion in sales last year, yet evidence pointing to its ineffectiveness as a decongestant goes back about 50 years.
![Rep Lisa McClain [pictured] is a Republican from Michigan. She has compelled FDA regulators to visit Capitol Hill to explain why it took so long to find that oral forms of phenylephrine, a common ingredient in decongestants, was as effective as a placebo pill](https://i.dailymail.co.uk/1s/2023/12/04/19/78565955-12824629-image-a-14_1701719219661.jpg)
Rep Lisa McClain [pictured] is a Republican from Michigan. She has compelled FDA regulators to visit Capitol Hill to explain why it took so long to find that oral forms of phenylephrine, a common ingredient in decongestants, was as effective as a placebo pill
An FDA panel voted in September unanimously that phenylephrine was ineffective. The vote does not mean that manufacturers must pull products from shelves, though some stores may follow CVS’ suit and stop selling them
The FDA’s Non-Prescription Drug Advisory Committee (NPDAC) voted unanimously in September to deem the ingredient ineffective in oral form. It is extremely common in brands like Sudafed, Tylenon, Benadryl, Alka-Seltzer, Mucinex, and Vicks Nyquil and Dayquil.
The ingredient is protected under the FDA’s Generally Recognized as Safe and Effective (GRASE) designation.
The vote did not mean that manufacturers would have to pull products containing the ingredient from shelves, though CVS did so soon after the two-day meeting ended.
But other major chains such as Walgreens and RiteAid have told DailyMail.com that they will only pull products from shelves if the FDA demands them to do so.
An order for top medicine manufacturers such as Vicks, Tylenol, and Robitussin to halt sales or reformulate could issue a major financial blow to the massive cold medicine industry, though it’s not clear if this factored into the FDA’s decision to keep the ingredient widely available for decades.
Rep McClain, chairwoman of the House Oversight Subcommittee on Health Care and Financial Services compelled FDA officials to arrange a meeting by next week. It is not clear yet whether the meeting will be public.
She said: ‘What is the point of having an FDA if they can’t do their jobs? Americans deserve better, and @GOPoversight is holding the FDA accountable for this colossal failure.’
Phenylephrine hit the market in the 1930s and has been used in more than 260 over-the-counter cold medicines since the 1970s.
The medication was meant to constrict blood vessels to clear congestion.
The medicine is metabolized in the gut, allowing just a fraction to enter the bloodstream, which is how it reaches the nose.
In fact, briefing documents compiled by the FDA show that less than a one percent concentration of the drug is able to reach the nose after being broken down in the gut.
The documents detailed flaws in the trials for the ingredient in the 1960s and 1970s, citing small sample sizes and relied on techniques no longer used by the FDA to approve medications.
Dr Leslie Hendeles, an expert at the University of Florida in pharmacokinetics, or the way medicines move throughout the body, was the first to critique phenylephrine in 1993 in a study that compared the efficacy of that and other more cold remedies including pseudoephedrine, the main ingredient of Sudafed.
He found that phenylephrine in pill form is rapidly absorbed in the gut and eliminated before it can have any effect, rendering it essentially worthless.
Two scientists who took down dud cold med feel ‘vindicated’
The FDA’s announcement last month that the main ingredient in the US’ favorite cold and flu meds didn’t work was ‘vindication’ for the two scientists who dedicated 20 years to proving it was a dud, Dr Leslie Hendele [left] and Dr Randy Hatton [right].
At the same time At the time, UF professor Dr Randy Hatton was running a pharmacy research lab at UF where students would field questions from medical professionals about certain drugs and work to find the answers.
They were suddenly receiving an influx of calls from pharmacists saying customers have complained about their cold medicines not working.
This prompted Drs Hatton and Hendeles to compile every study they could find on phenylephrine, evaluate them all, and in 2007 conclude that the standard 10-milligram dose was no more effective than a sugar pill.
Rep McClain said in her letter to the FDA: ‘Americans seeking OTC relief should not have to worry whether they are wasting their hard-earned money on ineffective drugs.
‘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.’
Phenylephrine differs from the ingredient found in Sudafed, which is called pseudoephedrine and has typically been considered more effective.
But it’s also a highly sought-after chemical precursor in clandestine labs manufacturing methamphetamine, a fact that until Breaking Bad character Jesse Pinkman showed up in Americans’ living rooms, many may not have known.
Because of this, Sudafed purchases are limited to just one box per customer and must be procured from behind the pharmacy counter.