This memorandum, written in 1985 by attorneys for the American Association of Homeopathic Manufacturers, describes a meeting between the AAHP attorneys and high-ranking FDA officials to discuss whether homeopathic products must be proven effective to remain legally marketable. The memo labels FDA officials who believed that homeopathic products should meet this standard as “hardlines.” Negotiations of this type led to the issuance in 1988 of an FDA Compliance Policy Guide that permits homeopathic products “intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment” to be marketed as nonprescription drugs. Combined with lax enforcement, this policy fails to protect consumers.
To: Members of the American Association of Homeopathic Pharmacists
From: Robert G. Pinco, Robert E. Pokusa
Re: Meeting with Dan Michels, Director of FDA’s Office of Compliance
Date: February 12, 1985
On Thursday January 24, 1985, a meeting was held between representatives of the American Association of Homeopathic Pharmacists (“AAHP”) and Daniel C. Michels, Director of FDA’s Office of Drug Compliance. The meeting was prompted by regulatory action which had been taken by the FDA’s Office of Compliance against certain homeopathic manufacturers within the past month. In particular, the meeting was called to address the position of the office of Compliance regarding the status of homeopathy within the United States and the manner in which FDA intends to regulate the practice of homeopathy. Those present on behalf of the American Association of Homeopathic Pharmacists were Robert Pinco and Robert Pokusa of the law firm of Perilo, Duerk & Pinco, Willard Eldredge, President, AAHP, Donald Lee, president, Boericke and Tafel, Suzanne De Florez, President, Humphreys Pharmacal and John A. Borneman arid Jay Borneman, President and Vice President, John A. Borneman and Sons. The FDA was represented by Daniel C. Michels, Director of Compliance, Albert Lavender, Deputy Director, Division of Drug Labeling Compliance, William Nychis , National Coordinator, Richard Chastonay, Chief of Prescription Drug Labeling Compliance and Joel Aronson, Acting Chief of Fraud Branch. The meeting began at 2:00 p.m. and lasted for approximately one hour and fifteen minutes.
Initially, Bob Plnco introduced those present and stated to Michels that the meeting was requested on behalf of the AAHP and not on behalf of the particular homeopathic manufacturers against whom FDA has recently taken action. Bob explained that the Associa-tion was particularly troubled by certain language contained in FDA’s regulatory letters, which stated that all of the products of the homeopathic manufacturers under investigation were new drugs for which there had been no approved new drug applications. Bob stated that this language implied that the Office of Compliance has now taken the position that all homeopathic remedies are new drugs and that such products will need to be approved by the FDA prior to being marketed. Bob then noted that if this was FDA’s position it would effectively eliminate the practice of homeopathy in the United States, since there are no homeopathic products which have been approved under the new drug application process.
Bob then went on to outline the basis for the practice of homeopathy in the United States and the arrangements which had been reached with FDA in the past. In this respect, Bob noted that homeopathy has been practiced in the United States since the early 1800’s and that the practice of homeopathy was specifically recognized in the Federal Food, Drug, and Cosmetic Act. [He reminded Michels that the author of the 1938 Food, Drug, and Cosmetic Act, Senator Royal Copeland, was a homeopathic physician.] Bob also pointed out that in the past the AAHP had reached certain agreements with the FDA relating to the practice of homeopathy. These included an informal agreement relating to the over-the-counter use of homeopathic products as well as the recognition by FDA of the legitimate rights of homeopathy to exist as an alternative to traditional medical practice. Bob stated that the homeopathic community was not seeking an exemption from regulation by the FDA, but was merely trying to determine what was expected of it and how it could determine whether the practices within the homeopathic community complied with FDA’s perception of the legitimate practice of homeopathy.
Dan Michels, responded on behalf of the agency. Michels initially noted that the FDA’s perception of the practice of homeo-pathy within the United States today is markedly different than the perception a few years ago. It was Michels’ view that until recently the practice of homeopathy was relatively small, that the majority of products manufactured were produced in conformity with the Homeopathic Pharmacopeia, that such products were limited to the use of health care professionals, that most products contained no specific indications for use and that most of these products consisted of individual ingredient remedies.
Michels then went on to note that there has been a dramatic change in the marketplace in the past several years and that the Pharmacopeia and the AAHP have not kept abreast of these changing conditions. In this respect, he noted that there are now numerous homeopathic products on the market which are being sold for a variety of serious conditions and that these are of particular concern to the FDA. Michels also noted that the whole issue of the legitimate sale of homeopathic products has somewhat muddied the fact that a great number of homeopathic products are now being sold over-the-counter with specific indications for use and that a much greater emphasis has been placed on marketing these products in a manner similar to the sale of allopathic over-the-counter products.
As a result of the changing nature of homeopathy, Michels said that he was not in a position to articulate any “neat” formula which could be used to determine whether certain products are legitimate homeopathic remedies.
In response, Bob Pinco stated several of Michels’ assumptions were not entirely accurate and, Mrs. De Florez, Bill Eldredge and Don Lee tried to correct his misunderstanding. Bob Pinco also stated that the AAHP had been actively seeking to establish a “regulatory” formula which could be utilized by the FDA. He stressed that, given the number of homeopathic products on the market, it would be impossible for FDA to undertake a full review of the products to determine the validity of these remedies. He also emphasized that the traditional homeopathic remedies are not subject to the same type of proof of efficacy as allopathic products and that this causes additional problems for FDA in reviewing such products. Bob stated that the AAHP had, in the past, presented several proposals on regulating homeopathic products.
Bob then proposed that a workable approach for determining the validity of a particular product might be to: (a) determine whether the ingredients in the product are contained in the Homeopathic Pharmacopeia of the United States; (b) determine whether the indications for use are consistent with the specific symptomatic indications in the homeopathic literature; and (c) limit homeopathic over-the-counter products to those which are similar to products contained in FDA’s OTC monographs. Bob stated that this was not a final proposal, but merely one option that would provide a system which was predictable and capable of application by the FDA.
In response, Michels agreed that the agency did not have the resources nor the inclination to review all existing homeopathic products. Michels requested that the AAHP dust off the recommenda-tions which they had previously submitted to the agency, combine these with any new recommendations and come up with a general proposal. Bob indicated that the AAHP would welcome this task and that such general recommendations would probably be similar to the points noted above.
Finally, Michels emphasized that FDA’s concern did not focus on all of homeopathic products or manufacturers, but that the FDA was concerned with the rapid growth in homeopathy and the potential for abuse as new companies come into the market and attempt to sell products for a wide variety of uses.
At this point, Michels asked for input from the other members of the office of Compliance, most notably Albert Lavender, Deputy Director, Division of Drug Labeling Compliance and William Nychis, National Coordinator. [Both Mr. Lavender and Mr. Nychis are enforcement “hardlines.”] Nychis and Lavender immediately raised questions as to the manner in which the effectiveness of homeopathic products could be measured, the status of combination homeopathic products and the method suggested for determining whether products were legitimate homeopathic remedies.
Initially, Nychis expressed concern that under any of the methods proposed by the AAHP there would be no basis for proving the effectiveness of these products. In response an attempt was made to show that homeopathic remedies were not capable of being reviewed in the same manner as allopathic products, but that under the formulation proposed the specific ingredients in each product could be viewed against the homeopathic literature to insure that the indications for particular products conformed with such literature. In addition, we noted that if ingredients were limited to those contain in the Homeopathic Pharmacopeia there would be some assurance that the products contained ingredients which were generally recognized as effective in the homeopathic community. In the past, both Nychis and Lavender had expressed doubts as to the status of all homeopathic products based on the lack of proof of efficacy and they reiterated this position at the meeting.
A second issue which was raised by both Nychis and Lavender related to the status of combination products. Neither Nychis nor Lavender were willing to concede that combination homeopathic remedies could be marketed on the basis that specific ingredients were previously recognized as being grandfathered. There was no resolution on this point and it is clear that Nychis would like to limit new combination products on the ground that any new combination of ingredients results in a new drug product.
The third point which was raised related to the proposed method for determining which products were, in fact, homeopathic remedies. Both Nychis and Lavender argued that the Homeopathic Pharmacopeia should be accorded no status except as a technical source book for the preparation of certain homeopathic ingredients. Thus, they argued that a requirement that homeopathic products contain only ingredients found in the Pharrmacopeia was no assurance that such product would be a valid or effective homeopathic remedy. In response, we noted that in making a determination as to which ingredients were to be included in the Homeopathic Pharmacopeia a comprehensive review of the ingredient, including its potential uses and the substantiation for such uses, was undertaken. Therefore, the Homeopathic Pharmacopeia was somewhat different than its allo-pathic counterpart.
A second point which was also raised related to the fact that not all persons darning to be homeopaths recognized the legiti-macy of the Homeopathic Pharmacopeia. The point was made that manufacturers whose ingredients were not recognized in the Pharmaco-peia would still claim that these were valid homeopathic remedies. A response to this contention was not clearly articulated at the meeting, however, a simple response would be that the AAHP proposal is not intended to be all inclusive. Rather it would provide a simple basis for determining whether certain products re recognized homeopathic remedies. In those instances where a manufacturer wishes to market a product which contains ingredients not found in the Homeopathic Pharmacopeia, the manufacturer would hear the burden of establishing that the specific ingredient was recognized in the homeopathic community and that there was support for its use in a particular formulation.
By the end of the meeting it was evident that William Nychis and Albert Lavender would continue to press for a strict standard against.which all homeopathic products would be measured. If these individuals were able to set policy, each homeopathic product would be deemed to be a new drug which would require prior approval by the FDA. However, it was also clear that Dan Michels, the senior FDA official at the meeting was looking for some middle ground between the hard-line articulated by his staff and the position of the AAHP. His call for the Association to submit a detailed proposal as to the method for regulating homeopathic products was a clear manifestation of this middle ground position.
Given the opportunity presented at the meeting, it would be unconscionable for the Association and other members of the homeopathic community to let the moment pass on this issue. This is particularly true since it can be expected that Lavender and Nychis will continue to lobby for a extremely strict interpretation as to the status of homeopathy. Accordingly, it is imperative that the Association and others act, and act quickly, to submit to Michels a detailed proposal on the manner in which homeopathic products can be regulated by the FDA. In developing such a proposal we will need to keep in mind that the proposal should he one which can be effectively applied by the Office of Compliance in its dealing with those manufacturers whose practices may he questionable and that such a formulation be one which could be accepted by the vast majority of legitimate homeopathic manufacturers within the United States. In light of the recent activity by the office of Compliance we should plan on submitting such a proposal within the next two months.
This page was posted on December 19, 2002.