NewsSpeak: FDA responds to homeopathy

Is there a place for homeopathy in the management of MS? #MSBlog #NewsSpeak

"Most chronic disease areas have attracted various alternative or complementary medicine practices, MS is no exception. Our survey on this blog done more than 2 years ago demonstrated that over 80% of pwMS use some form of complementary medicine. I must admit that I was slightly surprised by the survey. You may therefore be interested in reading the latest history of medicine perspective in this week's New England Journal of Medicine. It makes for an interesting read. My personal view relating to homeopathy as a treatment to MS is negative. I am not aware of any class 1 evidence showing that homeopathy is effective in the management of MS or in the management of any of the symptomatic problems that pwMS have." 



Podolsky & Kesselheim. Regulating Homeopathic Products — A Century of Dilute Interest. N Engl J Med 2016; 374:201-203.

Excerpts:

..... in March, the Food and Drug Administration (FDA) filed a request for public comments to learn what the public and physicians think about homeopathic drugs and whether its limited regulatory oversight of these products was “appropriate to protect and promote public health.”....

..... The agency then held a 2-day public hearing featuring homeopathic care providers and representatives of the homeopathic drug industry, as well as drug-safety experts....

..... in September, the Federal Trade Commission (FTC) held its own public workshop on the advertising of homeopathic products and whether it might violate section 5 of the FTC Act, which prohibits deceptive acts or practices affecting commerce.....

..... Oliver Wendell Holmes, who declared homeopathy a “mingled mass of perverse ingenuity, of tinsel erudition, or imbecile credulity, and of artful misrepresentation,” while noting the potential therapeutic effect on patients of “the strong impression made upon their minds by this novel and marvelous method of treatment.”...... 

....  In 1988, recognizing the increasing size of the homeopathic-drug market, the FDA issued a Compliance Policy Guide mandating conformity with good manufacturing practices and appropriate labeling regarding ingredients and directions for use. Homeopathic drugs used for “serious” conditions were to be prescribed by clinicians, whereas those offered for self-limited conditions could be sold over the counter. Thus, the FDA not only recused itself from evaluating the efficacy of remedies prescribed by homeopathic clinicians but also allowed over-the-counter homeopathic drugs to be marketed as therapeutic......

...... Unlike dietary supplements, which were explicitly excluded from rigorous FDA regulation in 1994, homeopathic products can actually be substantially regulated by the FDA, since the Food, Drug, and Cosmetic Act allows them to be sold as “therapeutic.” .....

...... We believe that, at minimum, regulators should reconsider the way homeopathic drugs are marketed, so that consumers who are seeking conventional medicines at pharmacies don’t become confused...... 

...... In August, the FTC submitted comments to the FDA recommending that the agencies better harmonize their approaches to regulating homeopathic products and their advertising.....

..... Reconsidering the over-the-counter sale of homeopathic remedies entirely would be an even more drastic step and would require the FDA to take on the entire industry for propagating remedies that don’t meet the same standards of scientific proof applied to conventional medicines.....

...... The recent actions by the FDA and FTC may finally signal the end of homeopathic drugs’ century-long evasion of regulatory scrutiny......

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