On October 23, in the District of Columbia, District Judge Randolph Moss denied a preliminary injunction, while allowing the case to proceed to trial, requesting to enjoin the Food and Drug Administration (FDA) from enforcing a ban on the importation of homeopathic injections that fail to meet safety guidelines laid out by federal statutes, as the enforcement decisions by the FDA allegedly violated the Administrative Procedures Act (APA). The court ultimately ruled that while the plaintiff lacked the requisite irreparable harm for injunctive relief at this stage in the litigation, the underlying claims survived a motion to dismiss as precedent confirmed that changes to an agency’s long-standing enforcement policies stood subject to judicial review for compliance with the APA.
The plaintiff, MediNatura, sold homeopathic injections from Germany in the United States until June 2020 when the FDA began banning importations of the injections at airports, on grounds that the injections failed to meet the safety standards imposed by the Federal Food, Drug and Cosmetic Act (FFDCA). The plaintiff argued that the importation ban was an APA non-compliant final agency action, as the FDA until 2019 published guidance stating homeopathic products need not comply with FFDCA requirements due to such products representing low amounts of sales relative to the drug industry overall and based on the reality that homeopathic products contain nominal amounts of stated active ingredients, further diminishing a need for elaborate safety reviews. As the plaintiff previously relied upon the guidance for three decades, alleged MediNatura, such a rescission of the enforcement guidance constituted a final agency action that mandated compliance with the APA’s requirements, including the mandate of a notice and comment period before rescission. Additionally, the plaintiff asseverated, the resigned enforcement standard gave the plaintiff grounds for an injunction to stop the rescission, as otherwise the rescission resulted in irreparable harm, specifically a potential loss of over 40% of the plaintiff’s revenue if injections were barred from import.
The defendant argued otherwise, claiming that the FDA’s previous decision to not require homeopathic products, including the plaintiff’s injections, to comply with the FFDCA in most circumstances, rooted itself in a prior understanding that the market for homeopathic products would remain limited, thus not worthy of disseminating limited agency resources in order to approve every new import, as is done with new drugs generally per the FFDCA. This new information, averred the defendant, warranted the rescission of the previous enforcement guidance for homeopathic products, with the new standard being the standard laid out by the FFDCA for all new drugs. To rescind the prior enforcement exception for homeopathic products, the defendant avowed, is to simply exercise the same discretionary powers that a prosecutor might maintain, and does not constitute a final agency action subject to APA review requirements. As such, the defendant sought to dismiss the plaintiff’s legal action since it was the FDA’s view that non-final agency actions that are rooted in an agency’s discretion of enforcement were per se not subject to judicial review.
The court disagreed, in part, with both parties. The court explained that the FFDCA requires “drug manufacturers to secure approval from the FDA before marketing any new drug.” The court further elaborated that a “drug” under the FFDCA are “articles intended for the ‘diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;’ and articles, other than food, ‘intended to affect the structure or any function of the body of man or other animals.’” Homeopathic injections, whether imported or otherwise, the judge ruled, meet this definition of a drug and statutorily give the FDA discretion to enforce the safety requirements for all homeopathic products, before said products can be marketed in the United States.
The court, however, stopped short of holding that the FDA must enforce the FFDCA standards for all homeopathic products or that the FDA could not legally create exceptions to the enforcement without violating the FFDCA. The court ultimately ruled that such questions could be pursued at the trial phase, as the defendant’s rescission of the 30-year old homeopathic product safety guidance in 2019 was indeed a final agency action subject to judicial review under the APA, as the guidance “created rights or obligations,” given that prior to the rescission of the guidance, the FDA previously enforced its mandates, albeit in lieu of enforcing the requirements of the FFDCA. Theretofore, the court denied the FDA’s motion to dismiss. The court also denied the plaintiff’s preliminary injunction, ruling that the plaintiff failed to provide appropriate evidence of the stated irreparable harm of loss of revenue.
Medinatura is represented by Morgan, Lewis and Bockius, LLP.
