Why DID it take FDA so long to tell us our cold meds don’t work? House Republicans summon FDA to explain why decision on over-the-counter decongestant took 50 YEARS
Republicans will let Food and Drug Administration officials explain why it took so long for a common nasal congestion drug to be deemed ineffective, despite years of evidence.
Michigan Republican Rep. Lisa McClain has spearheaded this effort, giving regulators until Dec. 11 to schedule a visit to Capitol Hill to officially meet with members of the House of Representatives.
The FDA announced in September that phenylephrine, long used as a decongestant in popular oral medications such as Sudafed PE Sinus Congestion and Vicks Nyquil Severe Cold and Flu, was no more effective than a placebo in relieving nasal congestion.
Drugs containing it generated sales of nearly $1.8 billion last year, but evidence pointing to its ineffectiveness as a decongestant goes back some 50 years.
Representative Lisa McClain (pictured) is a Republican from Michigan. She has forced FDA regulators to visit Capitol Hill to explain why it took so long to discover that oral forms of phenylephrine, a common ingredient in decongestants, were as effective as a placebo pill.
An FDA panel unanimously ruled in September that phenylephrine was ineffective. The vote does not mean manufacturers will have to pull products from shelves, although some stores will follow CVS's lead 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 very common with brands such as Sudafed, Tylenon, Benadryl, Alka-Seltzer, Mucinex and Vicks Nyquil and Dayquil.
The ingredient is protected under the FDA's GRASE (Generally Recognized as Safe and Effective) designation.
The vote did not require manufacturers to pull products containing the ingredient from shelves, although CVS did so shortly after the end of the two-day meeting.
But other major chains such as Walgreens and RiteAid have told DailyMail.com that they will only pull products from their shelves if the FDA requires them to do so.
An order for top drug makers such as Vicks, Tylenol and Robitussin to halt sales or reformulate could deal a major financial blow to the vast cold medicine industry, although it is not clear whether this played a role in the decision from the FDA to keep the ingredient widely available to healthcare. decades.
Rep. McClain, chairman of the House Oversight Subcommittee on Health Care and Financial Services forced FDA officials to make an appointment next week. It is not yet clear whether the meeting will be public.
She said: 'What's the point of having an FDA if they can't do their job? Americans deserve better, and @GOPoversight holds the FDA responsible for this colossal failure.”
Phenylephrine came onto the market in the 1930s and has been used in more than 260 over-the-counter cold medications since the 1970s.
The drug was intended to constrict blood vessels to clear congestion.
The drug is metabolized in the intestines, with only a fraction entering the bloodstream and reaching the nose.
In fact, briefing documents compiled by the FDA show as much less than one percent concentration of the drug can reach the nose after being broken down in the intestines.
The documents detail shortcomings in studies of the ingredient in the 1960s and 1970s, which cited small sample sizes and relied on techniques no longer used by the FDA to approve drugs.
Dr. Leslie Hendeles, a University of Florida expert on pharmacokinetics, or the way drugs move through the body, was the first to criticize phenylephrine in 1993 in a study comparing its effectiveness to other, more common cold medications , including pseudoephedrine, the main drug. ingredient of Sudafed.
He discovered that in pill form, phenylephrine is quickly absorbed in the intestines and eliminated before it can have any effect, making it essentially worthless.
At the same time, UF professor Dr. Randy Hatton at the time ran a pharmacy research lab at UF, where students answered questions from medical professionals about certain medications and worked to find the answers.
They suddenly started getting an influx of calls from pharmacists saying customers had complained that their cold medicines weren't working.
This led Dr. Hatton and Hendeles to compile every study they could find on phenylephrine, evaluate them all, and conclude in 2007 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 help should not have to worry about wasting their hard-earned money on ineffective medications.
“It is important that the American people have confidence in the FDA's approvals and trust that the medications they purchase are not only safe, but also effective.”
Phenylephrine is different from the ingredient in Sudafed, which is called pseudoephedrine and is generally considered more effective.
But it is also a highly sought after chemical precursor in clandestine labs where methamphetamine is manufactured, a fact that many may not have known until Breaking Bad character Jesse Pinkman appeared in Americans' living rooms.
Therefore, Sudafed purchases are limited to only one box per customer and must be purchased behind the pharmacy counter.