AAHP’s Views on Aspects of FDA’s Revised Draft Guidance

Since 2015, the Food and Drug Administration (FDA) has been engaged in a reevaluation of Compliance Policy Guide 400.400, Conditions under Which Homeopathic Drugs May Be Marketed. FDA issued a new draft policy in December 2017, and, after a public comment period, it issued a revised draft in October 2019, again with an invitation for public comment.

A number of organizations have taken extreme positions concerning the potential impact of the revised guidance, possibly because of a misunderstanding of the legal structure which governs FDA actions. The American Association of Homeopathic Pharmacists (AAHP), which represents the manufacturers and marketers of virtually all homeopathic drugs in the United States (based on unit volume), believes that these extreme and alarmist publications pose a far greater potential danger to homeopathy in the United States than does FDA’s revised draft guidance. No organization has more at stake in this matter than AAHP members and their customers. Upon careful and thoughtful analysis, including more than three decades of interaction with the agency, AAHP does not believe that the revised FDA draft guidance poses a meaningful risk to the continued availability of homeopathic drugs in the United States.

Clearly, FDA has increased the rhetoric in its statements about homeopathy, referring to these products as “unapproved new drugs” and “illegal drugs.” However, FDA’s rhetoric is just that, rhetoric. FDA’s pronouncements about the status of homeopathic drugs reflects the agency’s opinion, and nothing more. FDA’s opinions on the legal status of homeopathic drugs have no binding legal effect. FDA must seek the intervention of a court to enforce its views.

To answer the many questions AAHP has received to explain why its outlook is more positive toward the revised draft guidance than that of others in the homeopathic community, below are points of clarification:

 

Claim: FDA’s revised draft guidance will result in the unavailability of homeopathic drugs in the United States.

Reality: FDA itself has stated that most homeopathic drugs would be unaffected by the revised draft guidance. The revised draft guidance gives FDA no new legal authority it did not have under CPG 400.400. CPG 400.400 did not restrain FDA’s ability to act quickly and decisively to seek the removal of certain homeopathic drugs from the market when it believed the public health so required. Similarly, the revised draft guidance simply lays out categories of homeopathic drugs more likely to be the subject of enforcement action.

 

Claim: FDA has declared homeopathic drugs to be unapproved new drugs and, thus, illegal.

Reality: The legal status of homeopathic drugs is exactly the same now under the revised draft guidance as it has been for the past quarter century.

FDA has indeed stated that homeopathic drugs are unapproved new drugs. It is FDA’s view that any drug which does not have an approved New Drug Application or which is not subject to an OTC monograph is an unapproved new drug. The use of the word “new” does not have its common English meaning here. FDA uses the term “new” to mean a drug which it considers not to be generally recognized as safe and effective.  It is the legal theory which FDA uses for enforcement.  However, FDA’s view is not self-executing. To turn its view into a legally binding position, FDA must (with the permission of the U.S. Department of Justice) bring a legal action against a drug or its manufacturer. Until a court issues a judgment holding a product to be an unapproved new drug, FDA’s view has no legally binding effect.

Further, FDA would have to take action against each marketed homeopathic drug separately. FDA has no authority to declare an entire class of drugs illegal, nor is it likely a court would do so. Likewise FDA has no authority to declare a single ingredient used in many products illegal unless the agency declares a public health crises.

There are more than one thousand prescription drugs on the market that do not have approved New Drug Applications and have been on the market since the 1960s. These conventional drugs are expected to remain available to the public and FDA has issued another guidance document that explains how it will exercise its enforcement discretion with regard to those drugs.

Finally, FDA itself stated that most homeopathic drugs would not fall within the enforcement priorities outlined in the revised draft guidance.

 

Claim: Homeopathic drugs are grandfathered under the Drug Amendments of 1962.

Reality: The Drug Amendments of 1962 added the efficacy requirement to the Federal Food, Drug, and Cosmetic Act. Congress drafted a provision to that law that exempted certain drugs from the efficacy requirement. Regardless of what Congress’s intent may have been, FDA, with the concurrence of the courts, has read the grandfather clause out of the statute. FDA has not found a single drug to be grandfathered in more than 50 years.  It is unrealistic and dangerous to suggest that FDA will find thousands of homeopathic drugs to be grandfathered.

 

Claim: Homeopathic drugs are generally recognized as safe and effective.

Reality: A drug that is generally recognized by qualified experts to be safe and effective is not, under the statute, a new drug and does not require pre-market approval by FDA. The only drugs that FDA accepts as generally recognized as safe and effective are those OTC drugs that are subject to and in compliance with a final OTC Review monograph.

While the issue of the general recognition of homeopathic drugs has never been litigated, the U.S. Supreme Court has held that general recognition of safety and effectiveness requires at least as much data as is required for approval of a New Drug Application. It is not realistic to believe that a meaningful number of homeopathic drugs can produce that level of data.

 

Conclusion:

AAHP believes that FDA’s revised draft guidance will have little practical impact on the vast majority of homeopathic drugs available in the U.S. AAHP also believes that the greatest existential threat to the industry today is not FDA but rather manufacturers and distributors marketing products not in compliance with current Good Manufacturing Practices. These products risk an FDA recall request, call into question the entire industry’s ability to produce quality products, and taint the industry’s reputation through media coverage.