I have been in homeopathic practice for 36 years, and for the first time I have reason to think that there may be a serious threat to the availability of homeopathic remedies themselves. The situation is complicated, and this email I am asking you to send a personal letter or email to your elected representatives in Washington DC.
As many of you know, the federal Food and Drug Association (FDA), which is responsible for regulating the homeopathic manufacturing industry to ensure public safety, is proposing a dramatic revision to the “Compliance Policy Guide” which is a set of instructions and guidelines for its inspection teams and all staff members on how to assess and act regarding homeopathic medicines.
The old guide, which is went into effect 30 years ago, gave specific and useful guidelines that have provided an environment in which safety has been maintained at a very high level, and a stable market place enabled so that it is now possible to find homeopathic remedies at health-food and grocery stores and, more recently, at pharmacies like CVS, Walgreen’s etc.
But now, for unknown reasons, and despite two days of supportive testimony and a large submission of technical and scientific data which was submitted to the FDA, a new proposed Policy Guide will completely shift the FDA’s emphasis to enforcement of what it deems potentially dangerous. Should it be approved, it will completely eliminate the specific guidance of the former document. An overview of the new draft guidance (with links to the complete text), while apparently well-meaning, has already created problems in the marketplace.
The FDA is rightfully concerned that some homeopathic medicines marketed to the public have toxic starting materials (for example Belladonna, Gelsemium, Nux vomica, Aconite, and others). But the FDA no longer has the “institutional knowledge” that enabled it to develop the old Policy Guide, and does not understand that because of the very nature of homoeopathic manufacture, the doses of toxic ingredients are well below established levels of toxicity. By naming certain medicines in the new draft, large-scale retailers, wary of liability, are starting to question and may well stop stocking certain items, because of the perception that these medicines may become “illegal.”
Because these particular medicines are extremely useful in a wide variety of illnesses that can be used for self-treatment and sold in the “over-the-counter” market, their elimination would be a serious blow to consumers and to the economic viability of manufacturers participating in the US marketplace.
The current draft does not appear to have taken any account whatsoever of the comments and scientific data from the general public, homeopathic professionals, and industry obtained at or after the public hearing of 2015.
I have personally added comments to the public docket at https:// www.regulations.gov (see also instructions for non-electronic submission). The comment period has recently been extended to May 21st, 2018, so by all means please add your voice. However, I no longer believe that this action is sufficient to deal with the potential threat.
The homeopathic professional community, together with homeopathic manufacturers and others, including the National Center for Homeopathy, has been pursuing several strategies to deal with the situation. After attending the Board of Directors and Annual Meeting of the Membership of the Homeopathic Convention of the United States (my 34th year with this group, which maintains and publishes the Homeopathic Pharmacopeia of the United States) I have learned that there is now outreach to the United States Congress. This strategy is now seen as the most likely to succeed, in order to impress the political leadership of the FDA at their staff are taking actions which will actually make FDA’s job more difficult at the local level, thereby wasting human resources which could be better used for other more pressing issues, for a purpose which is not even justified in the first place.
The Homeopathic Pharmacopeia Convention has always reached out to the FDA to offer information, guidance, and education. These efforts appeared to have borne fruit in 2015 and 2016 resulting in the FDA sending two observers to sit in on committee meetings which were directly relevant to FDA’s mission. But about 12-15 months ago this cooperation completely disappeared without notice.
Senator Orrin Hatch, of Utah, a long-time supporter of “alternative medicine” has graciously authored a letter to the head of the FDA, Scott Gottlieb MD in order to support our efforts. Senator Bob Casey, of Pennsylvania, and 3 other Senators and 5 members of the House of Representatives have also signed on. We are looking to at least double those numbers, and I am seeking your help.
While reputable homeopathic manufacturers and homeopathic practitioners have ABSOLUTELY NO ISSUE with the FDA’s role in ensuring public safety by carefully monitoring compliance with appropriate manufacturing standards, I personally feel that is important that FDA reclaim the institutional knowledge that will enable it to effectively perform its mission to protect the public safety.
Interestingly, Dan Michels, who was the head of the Compliance office at FDA when the prior Policy Guide was negotiated and who had that knowledge, but who retired a number of years ago, was the last person to testify at the 2015 public hearing. He stated that the facts regarding homeopathy had not changed, and that there was no reason to change the policies put into place at that time. By enlisting the support of Senators and Representatives at the nation’s capital, we hope to favorably influence the problems that we see and to move forward into a better relationship with the FDA.
So I am asking you to join with me in contacting your elected representatives in Washington DC. When the voices of their constituents are received, it has much more impact than from other groups. I have it on good authority that your email and/or letter will be read.
I am specifically asking you to write to both of your US Senators AND the Representative for your District to support these efforts. I think that it is important to do as quickly as possible, in order to create a “crescendo” effect.
In the era of the internet, contacting your elected representatives has become straightforward. For the purposes of this particular outreach, please use: https://www.votervoice.net/AAHP/campaigns/57654/respond. While the “boiler plate” suggested here seems good, it is always best to personalize it in some way.
If you have any questions regarding this outreach, please feel free the contact me.
Please feel free to share this with anyone in the United States that you think might be interested.
Thank you for your help.
William Shevin MD, DHt.