PA Homeopathy - Dr. Bernardo A. Merizalde

PA Homeopathy Blog

Apr 2, 2015

Act now


The Food and Drug Administration’s Department of Health and Human Services is holding a public hearing this month to evaluate its homeopathic product regulation. They invite your comments and participation so act now. April calendar saying "Act now"

This action by the FDA—evaluating its “current enforcement policies for drug products labeled as homeopathic from scientific, risk and process perspectives…to promote and protect the public health”—is a great concern because it could be the first step in legislative action to limit the access and use of homeopathic products in the United States. Because there is so much disagreement between the scientific and the homeopathic communities, we as homeopathic users and prescribers need to make our voices heard in this process. You can read the specifics and contact information at http://1.usa.gov/1CnurTM.

However, it is important to clarify that part of the rationale for this hearing is questionable merchants and manufacturers. The current sale of products that are labeled homeopathic when their source is conventional prescription drugs—and  the regulatory process has been avoided—or biological products like hormones or animal tissues—which are not manufactured and tested according to the Homeopathic Pharmacopoeia of the United States, the official compendium of homeopathic products under the oversight of the Homeopathic Pharmacopoeia Convention of the United States, a task force that collaborates with the FDA to provide oversight over homeopathic products in the United States—is indeed cause for concern.

Though the meetings are primarily about such concerns, which are shared by the great majority of physicians and colleagues in the practice of scientific homeopathy, the hearings may have greater implications. That is why I am asking you to act now, as a user of homeopathy for your/your family’s healthcare and contribute a written statement about the effectiveness of homeopathy as a valid modality of medical treatment in public health.

Log on to http://1.usa.gov/19xDY02 and click on the comment tab to 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. Choose from the following based on your experience:

• What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?

• What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?

• Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA’s regulatory oversight of drugs labeled as homeopathic? If so, please explain.

• Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.

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

• A large majority of human drug products labeled as homeopathic are marketed as 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?

• 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?

• 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?

If you read the original notice (at the link provided in the first paragraph), you will see the document calls for “qualified experts,” but there is no specification as to what that would entail. It is possible that people called to be “experts” will have no knowledge or experience with homeopathy. You do, so please act now.

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