Decision in favor of FDA partially clarifies a somewhat gray area of the law regarding medications.
Issues of the Case
The FDA had issued a guidance document addressing how it would regulate homeopathic pharmaceuticals. The agency withdrew that guidance and subsequently added 6 prescription products a manufacturer wanted to import to its import alert list. The manufacturer sought an injunction to stop withdrawal of the guidance and seizure of its products.
Facts of the Case
In 1988 the FDA had adopted a guidance document titled Conditions Under Which Homeopathic Drugs May Be Marketed. This document reflected
an enforcement discretion decision made by the agency regarding how it would apply federal statutory requirements to pharmaceuticals in this classification. To put this in proper context, it is helpful to review the statutory treatment of homeopathic pharmaceuticals.
The Federal Food, Drug, and Cosmetic Act includes in the definition of a drug those “articles recognized in the official Homeopathic Pharmacopoeia of the United States,” as well as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” A final portion of the definition includes “articles [other than food] intended to affect the structure or any function of the body of man or other animals.” Further, the act declares it unlawful to distribute any new drug without FDA approval. A medication is considered a new drug if it is “not generally recognized...as safe and effective [GRAS/E] for use under the conditions prescribed, recommended, or suggested in the labeling thereof.”
In March 2015, the FDA said it was planning to revisit its enforcement policies applicable to homeopathic drugs. This was done in response to receiving numerous reports of “negative health effects from drug products labeled as homeopathic.”
Since the issuance of the 1988 enforcement guidance document, the agency had never approved a new drug application for a homeopathic pharmaceutical nor had it concluded that a product in that category was generally regarded as GRAS/E. As a general approach to regulating homeopathic products the agency had exercised its enforcement discretion, essentially meaning it withheld action because of a perception of a relatively minimal risk to patients.
In 2017, the agency announced it was eschewing the 1988 Compliance Policy Guide and adopting an approach “consistent with FDA’s risk-based enforcement approaches generally.” The categories of such products that posed higher risks and therefore a higher enforcement priority were “products that had safety concerns reported that contained potentially harmful ingredients or that posed a greater risk of harm to users due to their routes of administration.”
Pharmaceutical firm MediNatura, Inc, manufactured, imported, and distributed homeopathic products into the United States, including 6 from Germany, which were to be administered by injection. Those products met the standards of the FDA’s 1988 compliance guidance document.
In 2020 the agency issued a warning letter to the firm emphasizing that the products were “espe- cially concerning from a public health perspective because injectable products are delivered directly into the body...bypassing some of the body’s key defenses.” It was also noted that the products contained “potentially toxic or otherwise harmful ingredients.” The FDA’s conclusion was that these were “unapproved new drugs” that could not be distributed in the United States without the agency’s prior review and approval.
The manufacturer filed suit against the FDA, advancing 3 arguments that the agency had acted arbitrarily and capriciously or improperly to the detriment of the firm. It sought a preliminary injunction, wherein a federal trial court would order the agency to stop these enforcement actions directed at the firm and its products. The FDA opposed the granting of the preliminary injunction, arguing that neither the seizure nor the review and revision of the applicable FDA enforcement policy was final agency action eligible for judicial review.
While the matter was pending with the trial court the manufacturer dispatched 10 shipments of the involved products to the United States. Nine of those were detained and 1 shipment slipped through. FDA subsequently notified the firm that the 9 seized shipments were being permanently denied admission to the United States, because they were unapproved new drugs, based on the agency’s conclusion that they did not meet the GRAS/E standards. The trial court judge dismissed the manufacturer’s lawsuit. The manufacturer appealed to the relevant US Circuit Court of Appeals.
The appellate court concurred that the agency’s characterization of its changes in enforcement policy regarding homeopathic remedies was not “final agency action” and therefore not subject to judicial review. It also ruled that the manufacturer had failed to meet the standards for issuance of a preliminary injunction. Thus, the FDA prevailed on both arguments.
The Court's Reasoning
The court began by reviewing the criteria for an agency action to be considered “final.” Without belaboring the legal details, the court concluded that the change made by the FDA did not meet the criteria to be considered final.
The arguments related to issuance of the preliminary injunction sought by the manufacturer also came up short.
The burden of proving the 4 criteria needed to appropriately justify issuance of such an order rested with the manufacturer and the arguments advanced were insufficient.
About The Author
Joseph L. Fink III, JD, DSC (Hon), BSPharm, FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.