PA Homeopathy - Dr. Bernardo A. Merizalde

PA Homeopathy Blog

May 13, 2015

Open letter


To friends and colleagues

It was almost one month ago that we appeared in front of the FDA panel to answer the inquiry about “Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework after a Quarter-Century.” The original notice was a request for participants to attend and for written comments, from all interested parties, to be submitted. You can read the specifics and contact information at http://1.usa.gov/1CnurTM.

There were about 43 presenters, with only three who were confirmed skeptics, and two who were neutral. The great majority of the presentations were excellent and presented homeopathy in a clear and coherent manner; it has been rare to see the homeopathic community so united. Most of the presentations are available at the FDA website, though the quality of most of them is not good.

The panel was very respectful and professional. They patiently listened to our presentations, asked relevant questions, and appeared to learn about homeopathy along the way. Time will tell how this unfolds.

At this point, everyone who has an interest in keeping homeopathy available in the marketplace needs to add their voice to the discussion. If you want to be part of this, add your comments to the FDA website.

To submit your written comment, you can log onto http://1.usa.gov/19xDY02 and click on the Comment tab in the upper right of the screen. Make sure you organize and annotate your comments to identify the specific issue or topic to which they refer. Here are the basic questions and some general information.

1) What is your attitude, as a consumer or health care provider, towards products labeled as homeopathic?

(Describe how you feel about homeopathic products)


2) Can you say anything, from your experience, as to the risks and benefits of homeopathic products?

(Describe your own experience using homeopathy. Discuss how long you have used it, and what you have found it helpful for. If you have experience, describe if you see a difference between using conventional medicines and homeopathics)


3) Are the current enforcement policies under the FDA’s Compliance Policy Guide (CPG) appropriate to protect and promote public health? Are there alternatives to the current enforcement policies of the FDA's regulatory oversight of homeopathic? If so, please explain.

(According to the experts in the field and after much deliberation with colleagues and users, evaluating all of the information, the conclusion is that the FDA’s CPG is perfectly appropriate as it is, there is ample proof the FDA has done a very good job monitoring the market and taking out of the market those products which do not comply with homeopathic standards and could potentially be harmful for patients)


4) Are there areas of the current FDA’s Compliance Policy Guide (CPG) that could benefit from additional clarity? If so, please explain.

(The guide is clear enough, as noted above in point 3)


5) Is there information regarding the regulation of homeopathic products in other countries that could inform the FDA's thinking in this area?

(Yes, there is plenty of information out there; homeopathy is used in many other countries extensively with little government interference, and, in some, with government support)


6) A large majority of human drug products labeled as homeopathic are marketed as Over The Counter (OTC) drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?

(Discuss if you have had experience using OTC homeopathic medicines, if you have found the labels to be sufficient to gather information, and whether you would like to have the freedom to choose between conventional and homeopathic medicines)


7) Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?

(The above-mentioned Compliance Policy Guidelines, along with the Homeopathic Pharmacopoeia of the United States, are clear enough for companies to follow when they want to market an OTC homeopathic medicine)


8) Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic?

(Discuss whether you have adequate information to decide to use an OTC homeopathic product, and if not, what would help you gain that information--the stance from experts in the field is that homeopathic OTC products are not different from what is expected of conventional OTC products and are used according to same amount of information)



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