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The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.
"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."
FDA draft guidance (8 pages).
Also at Ars Technica and STAT News.
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(Score: 0) by Anonymous Coward on Thursday December 21 2017, @12:52AM (2 children)
From the opioid saga, the FDA has little credibility as interested in protecting patients over drug profits.
From the cost of new drugs versus their benefit over generics, same answer.
So what to do?
Do our job, fix the problem? No, of course not, that might be career affecting.
Instead, let's make a distraction so it will look like we are doing something useful.
Merry Christmas from the FDA.
If you happen to be a drug company, we definitely have your six.
It is interesting that Trump actually has direct experience in drug addiction, and the FDA runs merrily along.
(Score: 2) by MichaelDavidCrawford on Thursday December 21 2017, @01:33AM (1 child)
I was once prescribed Latuda as an antidepressant. It set the American taxpayer back thousands of dollars per month.
But it did nothing for me.
Back in the day I took the SSRI Paxil but it only "benefited" me in one way: I had infinite lasting power, because Paxil made me Anorgasmic.
My witch doctor replaced the Paxil with imipramine. My monthly supply was only $15.
I asked to switch from Latuda to amitryptiline. It has been generic for decades. I don't know the price because its low, low price is covered by Obamacare but I _can_ tell you that I'm doing really well these days.
In February I went to an emergency room because I had become suicidal. I knew that my depression was delusional but just knowing that I'm delusional doesn't make the delusion go away.
That's when I got set up with Latuda.
Decades of experience teaches me that if I'm not suicidal I can claim to be feeling pretty damn good.
Yes I Have No Bananas. [gofundme.com]
(Score: 3, Informative) by Azuma Hazuki on Thursday December 21 2017, @06:35AM
Be careful with imipramine and its ilk; those are tricyclics and have some nasty effects, I'm told. In particular they can cause serotonin syndrome, which is no fun at all.
I am "that girl" your mother warned you about...