The FDA hearing on regulation of homeopathic medicine was held in Washington DC on April 20, 2015 and continues on April 21, 2016. You can listen to live webcast on, April 21, 2015 at https://collaboration.fda.gov/hprapril2015/. Many members of the press were present. NPR Radio reported on the FDA hearing and CNN ran a story.
Speaking on behalf of the homeopathic community were the Homeopathic Pharmacopeia Convention of the United States, Homeopathic Association of Naturopathic Physicians, American Association of Homeopathic Naturopathic colleges and universities, College of Osteopathic Medicine of the Pacific, National Center for Homeopathy, American Association of Homeopathic Pharmacists and others. The FDA panel also heard from Matrixx Initiatives (the makers of Zicam), Holistic Mom’s Network, Peggy O’Mara, of Mothering.com, manufacturers of homeopathic medicine and a variety of homeopathic doctors, like Amy Rothenberg and Karl Robinson. The above mentioned parties spoke in support of homeopathy. The overall consensus expressed by these parties was that the current regulations by the FDA were working and sufficient to provide information to the public and answer public health concerns.
There were naysayers at the meeting who expressed their concerns about homeopathic remedies, but as the focus of was the subject of how to label homeopathic remedies, the FDA questions were addressed to this topic. A presentation by a researcher at University of Maryland discussed placebo effect. When a member of the FDA panel questioned if she was suggesting that the mode of action of homeopathic remedies was just placebo effect, her answer was vague and inconclusive. Her data showing the placebo effect for all medicines was around 30 percent clearly conflicted with the much higher success rate of homeopathic treatment success.
The FDA panel members voiced interesting questions that were not unlike conversations held within the homeopathic community itself. The FDA asked about the definition of homeopathy and how labeling could better inform the public when they are choosing from a shelf of retail remedies for a specific condition. For instance, if cold and flu remedies are on a pharmacy shelf, should the homeopathic remedies be on that shelf or on a separate shelf for homeopathic remedies? What labeling would help the public know when a remedy is homeopathic? They questioned what information would be best placed on the labels of homeopathic medicines and if more was needed. The FDA panel members asked if more information was needed, where could it be placed, for instance, on the Drug Facts information sheet, such as the kind that accompanies other pharmaceutical drugs. The question the FDA asked were concerned with the labeling of homeopathic remedies and how to make sure the public is informed to know when they are purchasing homeopathic remedies.
The overall tone felt mutually respectful to me and I am hoping that this meeting will open greater dialogue and collaboration between the FDA and the manufacturers of homeopathic medicines.
The public comment period is open until June 22, 2015.
Information on how to submit comments can be found here. https://www.federalregister.gov/articles/2015/03/27/2015-07018/homeopathic-product-regulation-evaluating-the-food-and-drug-administrations-regulatory-framework
Sources include:
FDA Hearing on Regulation of Homeopathic Medicine on April 20, 2015
http://www.fda.gov/drugs/newsevents/ucm430539.htm?hc_location=ufi
https://www.federalregister.gov/articles/2015/03/27/2015-07018/homeopathic-product-regulation-evaluating-the-food-and-drug-administrations-regulatory-framework
An award-winning screenwriter, Melanie has taught creative writing, and authored medical textbooks.
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