Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century

December 22, 2015

by Lisa Amerine, ND, DHANP

 

In the spring of 2015 it was announced by the FDA that they wanted to investigate Homeopathic product regulations in particular the labeling of Homeopathic Products. On April 20th and 21st there was a two day public hearing that was designed for the FDA to hear pros and cons about the current regulatory framework homeopathic in place for homeopathy.  There were 8 primary questions the FDA commissioners asked to gain a better understanding of homeopathy and the public’s perception of homeopathy.  The questions asked were the following:

  1. What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?
  2. What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of homeopathic drug products (HDPs)?
  3. Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the HDP 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.
  4. Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.
  5. Is there information regarding the regulation of HDPs in other countries that could inform FDA’s thinking in this area?
  6. 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?
  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?
  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?

 

To read the actual transcripts or to view the recorded video of the event please visit:   http://www.fda.gov/drugs/newsevents/ucm430539.htm

 

The questions were simple and the FDA commissioner team was very interested in the answers given.  The panel was very respectful towards our profession and asked very thoughtful and pertinent questions.  There were approximately 170 people in attendance, 8 FDA commissioners and cameras to provide a live webcam for anyone who chose to listen. The professionalism of our profession was top notch and exactly what I would want it to be at such an event.  The majority of the speakers were well prepared, incredibly professional and spoke highly of homeopathy.  From my perspective as a speaker at this hearing, never once did I feel my fellow colleagues undermined or condescended by questions asked.

I was however, taken by surprise the media’s response.  What the media reported versus what was actually talked about in this hearing were two different things. The media painted a picture that the FDA was out to kill off homeopathy, shut it down and try to once and for all put an end to such medicine. It is an interesting emotion when it is your comments that are twisted or taken out of context from the media.  The media’s reports left the general public confused, fearful and angry.  The unfortunate part to this is the public is upset and standing up against a conversation that is not even remotely accurate.

The goal of the FDA is to keep people safe, limit confusion and make sure the manufacturers are doing follows regulations. There is a lot of products on the market that will label themselves as “homeopathic” when in reality they are a supplement hiding under a few homeopathic remedies so they can make a different type of claim. Even worse there are products on the market that are labeled as “Homeopathic” that have never been homeopathic medications such as “HCG” or “IL4”.  These products are sold to consumers thinking it is homeopathy when in reality those who know homeopathy know very well it is not homeopathic. The problem lays in the portion of the population who does not know how to tell the difference. This is the issue the FDA is trying to clear up, they are not trying to shut down homeopathy. If this was the message the media gave to the public the response would be far different.  The FDA is trying to understand homeopathy and trying to align themselves with experts in the field to keep homeopathy as it is intended to be.

 

The following is the response to certain questions posed by the FDA on behalf of the Homeopathic Academy of Naturopathic Physicians.

 

Testimony by the Homeopathic Academy of Naturopathic Physicians By Lisa Amerine, ND, DHANP April 20, 2015

Introduction: Thank you for the opportunity to speak today at this public hearing. My name is Lisa Amerine; I am a Naturopathic Physician and am board certified by the Homeopathic Academy of Naturopathic Physician (HANP) with diplomate status in Homeopathy. Since a very young age my life has been committed to homeopathy and for the past 11 years I have maintained a highly successful private practice exclusively dedicated to Homeopathy in Lafayette, Colorado. Currently I also sit on the board for the HANP and I am the HANP House of Delegates representative for the American Association of Naturopathic Physicians (AANP), in which I represent the specialty field of homeopathy. I am also a co-leader on what is known as the Materia Medica Pura Project, a collective 30,000 + hour project with the purpose of collecting any existing literature on each homeopathic medicine. This literature includes any proving publications, toxicology reports, and cured cases for every homeopathic medicine. This information is then compiled in one document, the “Materia Medica Pura” and serves as the most up to date information for homeopathic medicines. This on-going project insures that there is up to date and correctly referenced literature on every individual homeopathic medicine.

The Homeopathic Academy of Naturopathic physicians’ is a specialty field recognized with in Naturopathic Medicine. Naturopathic physicians lead our communities throughout the US in natural health care. Physicians who specialize in homeopathy go over and beyond the already vigorous training received in homeopathy at naturopathic medical schools by undergoing further training in homeopathy. Upon completion of this process, which includes an additional board examination, they are awarded diplomate status. Practicing homeopathy is a true specialty in medicine and the diplomate status recognition rewards and acknowledges Physicians who have worked to achieve this status, setting them apart from any others who may be practicing homeopathy, thus Naturopathic Physicians with diplomate status in homeopathy are among the leading experts in homeopathy in the United States. The HANP also serves to further the excellence and success of homeopathy by providing continuing education that further sharpens the skill of not only the Diplomates but by physicians aspiring towards diplomat status. We also are committed to being an education resource for health care providers and the general public who may have questions regarding homeopathy.

Recommendations: HANP would like to respond to three particular questions posed by the FDA.

Question 1. What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?

The licensed homeopathic medical professionals have a vast knowledge of the Materia Medica, which lists the properties of the medicines we use. This literature, when employed in conjunction with consideration of the unique totality of symptoms with which a patient presents, forms the basis for the accurate prescription of homeopathic medicines. Well-trained homeopaths will only prescribe based on these principles. Therefore, medicines labeled as homeopathic, regardless of their source – including human drug and biological products – will not be prescribed unless there is the proper literature found in the monographs to support the prescription. The homeopathic health care professionals, especially those with diplomate status have very busy practices. Frequently we will train our patients regarding basic homeopathic medicines that they can purchase over the counter to take care of simple non-dangerous conditions like an acute cold. The consumers love this because they can try some basic things at home that are often very effective, safe and inexpensive to use. The health care provider likes this because it empowers the patient and leaves time for the physician to treat more serious conditions.

Question 4. Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.

The HANP serves to further the excellence in homeopathy by providing resources and continuing education for providers and the community. In an attempt to further the excellence in homeopathy the HANP believes that FDA’s CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed, needs some clarification. For example: 1. Definition number 2 states, “Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.” While the definition is clear, there is a loophole that many products are taking advantage of. This loophole provides manufactures the opportunity to put a substance in the “inactive” category while leaving the list in the active ingredients listed as HPUS homeopathic remedies that meets definition 2 per the FDA document. These inactive ingredients added are not always stabilizers but often a dietary supplement such as tea tree oil or aloe vera. This allows for manufactures to put products on the market and make an OTC drug claim when otherwise the product would be limited to a dietary supplement status. When this is done the product should not be considered a homeopathic drug, nor should be allowed to be marketed as such. The HANP believes this issue is a good example of where additional clarification could be helpful.

Question 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?]

The Homeopathic Academy of Naturopathic Physicians serves to provide quality education not only to other health care professionals but also to the lay public. Physicians, in particular, those with diplomate status are on the front lines of homeopathic health care and daily field questions from the consumer and from other health care providers regarding homeopathic products. These experts, because of their extensive knowledge of homeopathy can easily provide information regarding products, which are labeled as homeopathic and comment knowledgeably as to their efficacy and safety. There are many health care providers and consumers who know very little about homeopathy. Our goal with in the HANP is to be able to provide these people with quality information that can help guide them. Therefore the suggestion of the HANP is to maintain a team within the FDA that consists of experts in drug regulation, representative(s) of the American Association of Homeopathic Pharmacists (AAHP) and the Homeopathic Pharmacopoeia Convention of the United States as well as an expert clinical physician with diplomate status who is on the front lines of homeopathic health care and who is also committed to providing quality education to the public. A team comprised of such experts in the field is vital and will be able to help clarify any questions as to homeopathic labeling and most importantly help to ensure the safety of the consumer.

In closing today I would like to end with a story, 150 Years ago on a journey across the country on the Oregon Trail a group of explorers got stuck in the Cascade Mountains due to bad weather. They had to abandon their wagons and finish the trip on foot. They chose to bury their most valuable possessions so they could return to them when conditions were more favorable. Amongst one of those things buried was a small book written by a homeopathic physician, Constantine Hering, titled “The Homoeopathic Domestic Physician” and a small homeopathic medicine kit. For these people and people since then, homeopathic medicines have been effective and safe to use at home if their condition was intense enough to need attention but not severe enough for the care of a physician. There are many books such as this book that still guide the consumers in the lay public about making informed decisions regarding drug products labeled as homeopathic. Because homeopathy is safe and it is fairly easy for the consumer to understand what to buy should they have a minor health ailment, the HANP highly encourages that these homeopathic medicines continue to be available over the counter because they are so effective for helping improve the health of the population. Thank you for your time and consideration

 

The two day hearing was full of amazing testimony.  Dr. Amy Rothenberg said “the public loves homeopathy for many reasons including its efficacy but especially for its safety profile. The low cost of the medicines, as well as the consistent quality of product, make them appealing to both physician and patient. The consistency and quality are preserved by the American Association of Homeopathic Pharmacists (AAHP) and the Homeopathic Pharmacopeia of the United States (HPUS), using cGMP, and taught to physicians.”

The  American Association of Homeopathic Pharmacists (AAHP) noted that consumers buy homeopathic medicines based on the advice of health care providers, friends, family members and internet research.

Dr. Carl Robinson a long practicing homeopath out of Texas noted there are three levels to take into consideration when thinking about labeling.  The first level is for the consumer who knows nothing of homeopathy but saw a product at the store and wanted relief.  These people don’t know the difference between botanical medicine, supplement therapy and potentially even conventional medicine.  The second level is for the consumer who has tried homeopathy either because of a referral from a professional, friend, family or self research and saw great results.  This is the case for a speaker at this hearing, the founder of Holistic Moms Network and more importantly the mother of two boys Nancy Peplinsky.  She has come to love and trust homeopathy for many reasons including its safety and very low allergy profile for her children who suffer from allergies.  The third level is the professional who knows homeopathy well.  For this group labeling may not need to be so specific as a well trained practicing homeopath knows that there are potentially several hundred or even thousand indications for one homeopathic medicine.  Dr. Robinson suggested that a team be created to help distinguish between such levels as the issue at hand is very complicated.

A FDA commissioner who was a large part in updating the FDA’s CPG Sec. 400.400 document in the 1980’s, Daniel Michaels, urged the FDA to take note and to pay attention as we are a professional group and we are clearly not going away.  He suggested the FDA gain advice from us as they have for other issues where experts are needed to help guide the FDA.

The events that took place on April 20 and 21st in Silver Spring Maryland are important.  Daniel Michaels said he thought they would go away and never be successful enough to make it to this level, but that did not happen in the 1980’s and it will not happen now.  He is right, while there may be a lot of diversity in homeopathy, it is a real medicine and when practiced correctly homeopathy is amongst the leading modalities known to medicine.