11-08-2024, 09:52 AM
In a move which some might characterize as a response to 'political' developments... the Food and Drug Administration announced on Thursday that the are "beginning" the "process" of "removing" the oral decongestant 'phenylephrine' from the market because they are "not effective at relieving stuffy noses."
In fact, last year, FDA "advisers" unanimously voted that oral phenylephrine is ineffective. (50% of all households in the US used an oral decongestant over the last year according to a Consumer Healthcare Products Association survey. Oral phenylephrine is used in many OTC cold and cough medicines, including Advil, NyQuil, Sudafed, Robitussin, Tylenol, and Theraflu.
From ArsTechnica: After decades, FDA finally moves to pull ineffective decongestant off shelves
"It is the FDA’s role to ensure that drugs are safe and effective," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. "Based on our review of available data and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant."
For now, the order is just a proposal. The FDA will open up a public comment period, and if no comments can sway the FDA's previous conclusion that the drug is useless, the agency will make the order final. Drugmakers will get a grace period to reformulate their products.
Note that drug-makers will not be recalling the old merchandise from the shelves... and that they have 6-months to come up with anything they can get away with calling a "new formulation"... and guess what? It WILL be more expensive because... "blah blah research costs blah blah." (Never mind that 90% of the "research" is payed for by government grants siphoned from tax-payer dollars.)
And from the "War on drugs" Department...
... The decongestant was originally approved by the FDA back in 1976, but it came to prominence after 2006. That was the year when the "Combat Methamphetamine Epidemic Act of 2005" came into effect, and pseudoephedrine—the main component of Sudafed—moved behind the pharmacy counter to keep it from being used to make methamphetamine. With pseudoephedrine out of easy reach at drugstores, phenylephrine became the leading over-the-counter decongestant. And researchers had questions.
So the thing that did work, was "reformulated" to make it less prone to abuse... and rendered actually ineffective... for some two generations of citizens, who dished out billions seeking relief from congestion... FDA hard at work "protecting" 'safe and effective'... But no one ever mentioned that Merk and Johnson and Johnson found no significant difference between phenylephrine and a placebo in their research.
Last year, the FDA reevaluated the drug again, taking into consideration the new studies and taking a deeper look at the 14 studies from the 1950s to 1970s that earned phenylephrine its initial approval. The FDA noted that those 14 studies assessed congestion using a dubious measure of nasal airway resistance that has since been abandoned. But even with the shoddy measurement, the studies provided mixed efficacy results. And the overall finding of efficacy hinged on only two of the studies, which were conducted at the same lab.
Well... far be it from me to wave the "I told you so flag".... nah... I want to wave it. The FDA is an adjunct of Big Pharma lobbyists and more...
Bring on the culling of industry from the regulatory bodies of our government... it's LONG overdue.... shut down the revolving door of regulatory capture... or expose it for all it is.
In fact, last year, FDA "advisers" unanimously voted that oral phenylephrine is ineffective. (50% of all households in the US used an oral decongestant over the last year according to a Consumer Healthcare Products Association survey. Oral phenylephrine is used in many OTC cold and cough medicines, including Advil, NyQuil, Sudafed, Robitussin, Tylenol, and Theraflu.
From ArsTechnica: After decades, FDA finally moves to pull ineffective decongestant off shelves
"It is the FDA’s role to ensure that drugs are safe and effective," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. "Based on our review of available data and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant."
For now, the order is just a proposal. The FDA will open up a public comment period, and if no comments can sway the FDA's previous conclusion that the drug is useless, the agency will make the order final. Drugmakers will get a grace period to reformulate their products.
Note that drug-makers will not be recalling the old merchandise from the shelves... and that they have 6-months to come up with anything they can get away with calling a "new formulation"... and guess what? It WILL be more expensive because... "blah blah research costs blah blah." (Never mind that 90% of the "research" is payed for by government grants siphoned from tax-payer dollars.)
And from the "War on drugs" Department...
... The decongestant was originally approved by the FDA back in 1976, but it came to prominence after 2006. That was the year when the "Combat Methamphetamine Epidemic Act of 2005" came into effect, and pseudoephedrine—the main component of Sudafed—moved behind the pharmacy counter to keep it from being used to make methamphetamine. With pseudoephedrine out of easy reach at drugstores, phenylephrine became the leading over-the-counter decongestant. And researchers had questions.
So the thing that did work, was "reformulated" to make it less prone to abuse... and rendered actually ineffective... for some two generations of citizens, who dished out billions seeking relief from congestion... FDA hard at work "protecting" 'safe and effective'... But no one ever mentioned that Merk and Johnson and Johnson found no significant difference between phenylephrine and a placebo in their research.
Last year, the FDA reevaluated the drug again, taking into consideration the new studies and taking a deeper look at the 14 studies from the 1950s to 1970s that earned phenylephrine its initial approval. The FDA noted that those 14 studies assessed congestion using a dubious measure of nasal airway resistance that has since been abandoned. But even with the shoddy measurement, the studies provided mixed efficacy results. And the overall finding of efficacy hinged on only two of the studies, which were conducted at the same lab.
Well... far be it from me to wave the "I told you so flag".... nah... I want to wave it. The FDA is an adjunct of Big Pharma lobbyists and more...
Bring on the culling of industry from the regulatory bodies of our government... it's LONG overdue.... shut down the revolving door of regulatory capture... or expose it for all it is.
