This memorandum was written in 1985 by the attorney for the American Association of Homeopathic Manufacturers. The memo warns that if homeopathic products were required to meet to the same standards of safety and effectivess as other drug products, homeopathy would face extinction in the United States. Several passages have been underlined for emphasis. Subsequent negotiations with FDA officials led to the issuance in 1988 of an FDA Compliance Policy Guide that permit homeopathic products "intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment" to be marketed as nonprescription drugs.
As you are aware, a number of adverse regulatory actions have recently been initiated by the Food and Drug Administration against homeopathic products. I am deeply concerned that these actions, as well as certain attitude changes within the Agency, may be indicative of a shift in internal policy toward the stricter regulation of all homeopathic products. It is foreseeable that FDA may attempt to classify all homeopathic substances as "new drugs" requiring premarket clearance. This would represent a virtually unsurmountable burden for homeopathic manufacturers and distributors.
As General Counsel to AAHP, I offer this memorandum to acquaint you with some of the unfavorable actions and trends I have witnessed in recent months, and to suggest the need for an immediate, coordinated effort by the homeopathic industry to work with FDA to maintain a regulatory atmosphere which would permit the continued marketing of homeopathic products without imposition of unnecessary and unreasonable restrictions.
Pending regulatory actions by FDA against two homeopathic manufacturers may present a serious challenge to the continued existence of homeopathy in the United States. The Agency has issued a regulatory letter to Biological Homeopathic Industries, Inc. ("BHI") alleging violations of the new drug provisions of the Federal Food, Drug, and Cosmetic Act. It has also issued another regulatory letter to a homeopathic drug manufacturer in Sumas, Washington. You will recall that BHI was the subject of severe criticism by senior FDA officials at Agency meetings held over the last two years with the homeopathic community. BHI has just retained me as legal counsel in this matter and, because of the potential widespread impact of the proceedings, has authorized me to discuss the case.
The regulatory letter is of particular significance in two respects. First, it was signed by Dan Michels, FDA's Director of Compliance. It is the Agency practice for Michels to sign only the most important regulatory letters. Second, the letter directly contradicts the Agency's past policy toward homeopathic products. The letter states that "we are unaware of any substantial scientific evidence which demonstrates that any of your marketed homeopathic drugs are generally recognized as safe and effective for their intended use," and asks to be advised as to corrective measures the firm intends to take, "including the discontinuance of all marketed homeopathic drugs." Since BHI manufactures a large number of remedies for a wide variety of conditions, the implication is that FDA is taking the position that all homeopathic drugs are "new drugs."
This interpretation was confirmed in a meeting last week with Bill Nychis, National Coordinator of the Drugs and Biologics Fraud Branch, Office of Compliance, and Richard Chastonay, head of the Prescription Drug Labeling Branch. BHI had presented a proposal for the marketing of its products which contain only those ingredients recognized in the Homeopa:thic Pharmacopeia, and which are labeled in accordance with standard homeopathic indications. In essence, we offered an approach which would conform BHI's activities to those of norm in the U.S. homeopathic community for the last 150 years. Mr. Nychis and Mr. Chastonay rejected this suggestion, stating that in his opinion all homeopathic drugs are "new drugs" requiring premarket clearance.
It is well known that both Messrs.Nychis and Chastonay are "hardliners" with respect to homeopathy, but the position advanced by them is totally untenable, and would be the end of U.S. homeopathy. As we have discussed, we have scheduled a meeting with Mr. Michels next week on behalf of AAHP in an effort to reach a satisfactory resolution of the status of homeopathic drugs (see attached letters). The future of homeopathy must not be decided in the context of a regulatory action against a single manufacturer, but it should be determined from a policy point of view after careful consideration in a well-reasoned decision-making procedure.
The Agency attitude toward homeopathic drugs, as expressed to BHI, was not created in a vacuum, but is consistent with other recent developments. Homeopathic manufacturers have been feeling an immediate and direct impact from FDA's antiquackery campaign. The Agency is under considerable pressure from Congress, notably from Congressman Claude Pepper, Chairman of the Health and Long Term Care Subcommittee of the Committee on Aging, to take enforcement action against fraudulent drug products. In response, FDA and other agencies have begun a coordinated effort which has led to a series of detentions, seizures, criminal proceedings, and other adverse actions against alleged food supplement products. One prominent example of the current antiquackery campaign is the pending criminal proceeding brought against General Nutrition Inc. and its individual officers. The defendants are charged with conspiracy to defraud FDA by labeling the product Oil of Evening Primrose as a food supplement, but promoting it for therapeutic uses through media publicity, literature, and oral representations. Other counts charge misbranding of the product, in violation of the Food, Drug, and Cosmetic Act. This lawsuit is somewhat unusual in the creative application of the conspiracy statute, with severe criminal penalties of a maximum 5-year jail term and $10,000 fine.
Another action by FDA which may have a substantial negative impact on homeopathy is the Agency's modification of its combination drug policy. According to the Agency's latest Compliance Policy Guide issued to its field staff, almost all combinations of ingredients not specifically permitted by an OTC monograph will be viewed by FDA as "new drugs" requiring an approved New Drug Application prior to marketing. (Compliance Policy Guide 7132b.16 provides that combination products marketed after the-start of the OTC Review on May 11, 1972 are "new drugs" and subject to regulatory action if the Agency has dissented from an OTC panel's Category I recommendation for the combination, if the panel has recommended that the combination or one of its active ingredients is Category II or III, or if no OTC panel has considered the specific combination.) This policy is consistent with recent patterns of enforcement actions against combination products, such as toothpastes.
Although the Guide applies by its terms to OTC ingredients which are subject to the conditions of a final monograph (i.e., allopathic drugs), I believe that the policy expressed in the Guide will be extended to homeopathic drugs as well. In my experience, a general tightening in the regulation of all drugs by FDA will mean a commensurate tightening in the regulation of homeopathic drugs. The Compliance Policy Guide indicates to me that the Agency is heading toward a "snapshot" theory of regulation. In other words, only those conditions (ingredients, combinations, dosage levels, indications) which existed at the time of the OTC Review will be classified as Category I or generally recognized as safe and effective (GRAS/E). All other conditions will be considered "new" and consequently require NDAs. The "snapshot" theory is a rigid, inflexible approach to drug regulation which would effectively preclude or inhibit any further growth in the OTC market.
The homeopathic industry has largely enjoyed a laissez faire regulatory approach by FDA since 1978, when we forged the informal agreement with the Agency according favorable marketing status to homeopathic products. This agreement is now over six years old, and it appears that its effective life may be coming to an end. The weakening of the agreement is due in part to the fact that some of the senior personnel who consented to the Agency's noninterference with homeopathy have left the Agency, are leaving, or no longer occupy positions of influence. Current staffers in Compliance, such as Rudolf Apodaca, Richard Chastonay and Bill Nychis, are advocating a hard-line approach to drug regulation in general, including homeopathy, in particular. The Congressional interest in antiquackery actions has placed additional pressures on FDA to take regulatory action. Finally, homeopathy represented a relatively small share of the U.S. drug market in 1978 and FDA expected this medical specialty to wither and die. Its growing popularity is another factor in FDA's reconsideration of its enforcement policy.
It is clear that the status of homeopathy is currently undergoing reassessment by FDA. It is crucial that the homeopathic community in general and the homeopathic industry, in particular, have substantial input into the decision-making process. The first step is to develop a coordinated plan for the regulation of homeopathic products which is acceptable to the industry. Industry spokesmen must then approach FDA in a nonadversarial fashion, as representatives of the entire legitimate homeopathic community dissociated from any individual companies or actions. We must be prepared to use our strength with Senator Hatch, senior management at Health and Human Services, and high level FDA personnel.
It is imperative that the homeopathic industry take immediate steps to resolve the status of homeopathy with FDA before the Agency formulates any unilateral policy. once FDA issues a formal policy pronouncement, the chances of reaching an agreement which is acceptable to homeopathy will be greatly reduced. Our meeting with Dan Michels is a step in the right direction, but it is only the first step. We must be prepared to take whatever action is necessary to secure the position of homeopathy in the United States, before it is regulated out of existence.