FDA Review of Homeopathy

Update – August 2015

The U.S. Food and Drug Administration (FDA) has extended its comment period regarding Homeopathic Product Regulation to 21 August 2015. Our prior comments to the FDA (see below) are unchanged, but we encourage you to take advantage of this opportunity to solicit your own comments (electronic or written), or share ours, before this deadline. We also stand in support of others making similar comments, such as the Society for Science-based Medicine.

You may also like to review Regulation and Prevalence of Homeopathy (Wikipedia).

In April 2015, the FDA conducted a two-day public hearing as an open “listening” session to solicit public testimony to help inform the FDA about how to proceed toward modifying current regulatory policies regarding homeopathic products. The FDA asked for written comments before, during and following the hearing (deadline was 22 June 2015). The full agenda can be found here.

Given inherent concerns about the growth of the homeopathic industry despite the scientific consensus regarding its lack of efficacy and scientific implausibility, the EBVMA has submitted the following written comment to the FDA. We thank all of the members who contributed their thoughtful feedback and suggestions. Questions or comments may be sent to info@ebvma.org.

Wednesday, 8 April 2015

 

Food & Drug Administration
Division of Dockets
Management (HFA–305)
5630 Fishers Lane, Room 106
Rockville, MD 20852.

Re: Docket No. FDA–2015-N–0540–0001, Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century; Public Hearing

Regarding the FDA proposed rule regarding homeopathic product regulation pending review in April 2015, the Evidence-Based Veterinary Medicine Association (EBVMA) offers the following concerns, proclamations and recommendations.

The EBVMA is an international non-profit [U.S. 501(c)(3)] professional organization of veterinary healthcare professionals including academic researchers, private practitioners, and nurses. Founded in 2004, we support the research, training and the practice of evidence-based veterinary medicine (EBVM). EBVM is the formal domain designed to integrate the best available research evidence with clinical expertise and the unique needs of each client. Good research evidence is dependent on results from studies that have been well designed, that are statistically sound and have been critically evaluated.

If homeopathic products are to be manufactured, marketed, prescribed and used with assertions that they can treat or prevent disease in animals, they should be held to the same ethical and scientific standards of practice as other drugs or medicinal products.

The current regulatory structure effectively allows most homeopathic products to be marketed and used in animals, with or without the guidance of a veterinarian, and without any of the scientific evidence of safety and efficacy required of most drugs regulated by the agency. Furthermore, the failure to include these products within the same rigorous regulatory framework as any other medicinal product allows unchecked claims on their efficacy. This further distracts the public from the appropriate scientific information and relevant guidance required to make effective and informed decisions on their own or via informed consent under a valid relationship with a clinician.

The internationally accepted scientific consensus, including declarations by the FDA, is substantive and unequivocal that homeopathy provides no therapeutic benefit beyond the placebo effect. This holds true for both those who have the remedies prescribed or choose to administer those products to animals on their own. Further, this limit on any plausible general psychological impact from intervention on humans has little to no direct affect on our non-human patients.

Beyond their lack of efficacy is the concern that homeopathic remedies can in fact cause harm, even death, due to improper labeling of any non-homeopathic active ingredients or due to the failure to properly diagnose and match an appropriate therapy with medicinal products with a history of efficacy based on sound prospective scientific research.

Given this consensus, it is an abrogation of the FDA’s responsibility to protect animal health by allowing therapeutic and prevention claims to be made for these products.

We recommend the FDA take the following actions

  1. Draft and submit to Congress a report that identifies homeopathy as not proven to be effective. The report should recommend changes in the agency’s authorizing legislation that prohibit the marketing and use of homeopathic remedies/preparations without fulfillment of the same new drug licensing requirements applied to conventional drugs.
  2. Produce educational materials for healthcare providers (e.g., veterinarians and veterinary nurses) and veterinary clients that identify the systematic reviews and the actual scientific results (and their relative quality) of trials on homeopathy for the treatment or prevention of any animal disease.
  3. Require all over-the-counter homeopathic products to carry a label similar to that required for dietary supplements under the Dietary Supplement and Health and Education Act of 1994, such as:
    “This/these statement(s) have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
  4. Vigorously enforce regulations prohibiting treatment and prevention claims for homeopathic remedies without fulfillment of the requirements of a New Drug Application.

Signed,

EBVMA Board of Directors and Executive Committee

 

About Stuart Turner

Dr. Stuart W. Turner, a former emergency & critical-care veterinarian in Northern California, is a full-time biomedical informaticist (a healthcare information architect). His background includes post-graduate training, teaching and research in biomedical informatics. His work covers various realms such as clinical decision support, translational medicine, public health (biosurveillance) and the semantic interoperability of health information systems from the design of clinical information models and biomedical ontologies. He is past president of the Association of Veterinary Informatics and the Evidence-based Veterinary Medicine Association.

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About Stuart Turner

Dr. Stuart W. Turner, a former emergency & critical-care veterinarian in Northern California, is a full-time biomedical informaticist (a healthcare information architect). His background includes post-graduate training, teaching and research in biomedical informatics. His work covers various realms such as clinical decision support, translational medicine, public health (biosurveillance) and the semantic interoperability of health information systems from the design of clinical information models and biomedical ontologies. He is past president of the Association of Veterinary Informatics and the Evidence-based Veterinary Medicine Association.