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Make Comments to the FDA Now on the Draft Guidance

Dear NCH Member:

As you know, the Food and Drug Administration (FDA) issued a revised Draft Guidance for regulating homeopathy medicines in October 2019. Subsequent to this action, statements were issued by Americans for Homeopathy Choice (AFHC) and the American Association of Homeopathic Pharmacists (AAHP). Some in the homeopathic community have expressed concerns about whether some statements are “alarmist” or “exaggerated.”  Some in our community are confused by differing statements being released by respected organizations.

The Board of NCH has talked to both organizations and studied their statements. We are providing the following summary to help our members to better understand the situation and to enable them to make an informed decision on their actions.

Summary:

The two organizations have different opinions about the best strategy for responding to the FDA revised Draft Guidance. NCH believes that no one organization is completely right or completely wrong, because no one can predict the new path of the FDA on homeopathy matters, and much of what is written by the FDA is ambiguous and open to interpretation and speculation. 

Both organizations recognize the key issues of the revised Draft Guidance but differ on the expectation of FDA actions and their impact on homeopathic medications and on their availability. The AAHP does not believe the FDA is going to act on their written guidance, for many reasons, including underfunding, and lack of interest. They believe the FDA will leave homeopathy alone, apart from a potential few remedies, that there is no indication of or immediate danger to the entire group of homeopathic medicines and that the best course is to let this simmer down to avoid keeping the focus on homeopathy. The AAHP bases this on their decades long history of dealing with the FDA and their interpretation of the document. As manufacturers, they are especially concerned about the effect this situation may have on their customers, retailers, and chain retailers who are wondering about the stability of the homeopathic medicine market.

AFHC, on the other hand, believes that action needs to be taken now to intervene in the FDA’s revised Draft Guidance, in order to thwart the opportunity that the Guidance gives the FDA the power to act immediately or in the future to restrict homeopathic medicines. They reference wording in the Draft Guidance that supports their concerns about homeopathic medicines being endangered. They recognize that there are several unresolved and unspoken issues in the homeopathy field, and they believe, after years of ignoring them, it is the right time and opportunity to find solutions to them. They believe that solving these issues will strengthen homeopathy and boost its accessibility in the U.S. They also have been educating the FDA about homeopathy in key meetings with high FDA officials and have brought the consumer voice, opinion, and influence. They have the support of consumers and many national homeopathic organizations to convey this information to the FDA and to encourage the FDA to provide continued access, along with the assurance of a pure and safe product.

From the NCH point of view, there are three factors that define each group: outlook, pace, and timing. The manufacturers’ outlook is driven by and dependent upon their past working relationship with the FDA, and their ultimate concern is stability of the homeopathic market. Consumers expect the FDA to answer to their constituents, the consumer, and provide safety without restricting their choice of health treatment. Along with the AAHP, they also want a stable, accessible homeopathic market. In terms of pace and timing, AAHP wants to go more slowly and keep a low profile as they have done in the past. If any problems arise, they will handle them retroactively. AFHC wants to move now, using the consumer power they have garnered and the attention of the FDA to act proactively.

Action:

From the NCH viewpoint, although you may find differing opinions about strategy, we are in agreement that it is important to get as many comments as possible about the revised Draft Guidance to the FDA. You received an urgent call to action from NCH at the end of 2019 and others since. Since that time, the FDA has extended the deadline for comments to May 23, 2020. The goal is to get at least 100,000 comments to the FDA by that deadline. 

To impress upon the FDA that there are many people who are concerned about homeopathy, we are asking you to do two very important things:

  1. Submit a comment to the FDA docket and to members of Congress about homeopathy.
  1. Forward this email to your contacts and get every family member in each household—regardless of age—to submit a comment to the docket.

If you choose to comment:

According to the AFHC, the revised Draft Guidance has some helpful changes and some detrimental changes. Unfortunately, the detrimental changes are very detrimental, and we must now pressure the FDA to revise this Guidance considerably. We can do that by getting a very large number of people to comment on this new draft.

The AFHC gives this summary of the most important points:

  1. The revised Draft Guidance, if adopted, could provide the FDA with the authority to withdraw even properly manufactured and labeled homeopathic medicines from the marketplace.
  1. The FDA intends to use this authority and has even mentioned specific medicines such as Belladonna, Nux vomica and Lachesis mutans in its public statements regarding enforcement.
  1. The authority for this kind of assault on homeopathy will result in the declaration by the FDA that all homeopathic medicines are “new drugs.”

This declaration means that under federal law all homeopathic drugs will become technically “illegal” and subject to withdrawal from the marketplace.

  1. Since the agency has already expressed that it “thinks” that Belladonna, Nux vomica, Lachesis mutans and several other remedies are dangerous, we can anticipate that it will try to remove them from the marketplace as soon as the Guidance is finalized.
  1. Once this happens, the only conceivable way these remedies could be reinstated is to go through what the FDA calls a New Drug Application (NDA). But that’s not going to happen for two reasons:

First, no one can patent homeopathic remedies because they are made from common substances. So, no company would be able to make back the huge cost of going through the NDA.

Second, the NDA is designed for pharmaceuticals and is unable to test the effectiveness of a medicine that is tailored to each individual, rather than given to a large mass of people who supposedly have the same condition. Hence, it is unlikely that any homeopathic medicine would be ruled safe and effective by the FDA.

Help us get the FDA to change the revised Draft Guidance in ways that will protect rather than imperil homeopathy. Using the talking points above, submit a comment directly to the FDA docket by clicking on the button below.

FDA DOCKET

If you prefer, you can submit your comment through the AFHC Voter Voice system using the button below. There you’ll find out how to make a comment. When using this system, your comments will also be directed to your Congressional representatives, as well as the President and Vice President of the United States. You will be asked to enter your contact information including name and email. AFHC created background information to help you construct your own comment to the FDA while highlighting key issues relating to the most recent revised Draft Guidance. 

AFHC CHOICE VOICE

Thank you for your commitment to homeopathy, for learning about this issue, and for taking this important action. 

Deb Dupnik
Executive Director
The National Center for Homeopathy