Health Law Daily FDA withdrawal of regulatory policy was an agency action subject to judicial review
Tuesday, October 27, 2020

FDA withdrawal of regulatory policy was an agency action subject to judicial review

By Jeffrey H. Brochin, J.D.

FDA withdrawal of Compliance Policy Guide (CPG 400.400) pertaining to homeopathic drugs was subject to judicial review because enforcement was not left to agency discretion and the recission in fact had legal consequences for the regulated parties.

A federal district court in the District of Columbia has granted in part and denied in part the motion to dismiss filed by the Food and Drug Administration (FDA) in a lawsuit brought by a MediNatura, Inc. (MediNatura) a homeopathic drug purveyor whose imported injectable drugs were listed on the Import Alert roster of the U.S. Customs Service by order of the FDA. Although the drugs were properly labeled and manufactured, the CPG policy that formerly regulated the drugs was rescinded in 2019, leading to the purveyor’s filing of the instant lawsuit (MediNatura, Inc. v. FDA, October 23, 2020, Moss, R.).

History of homeopathic drug regulation. For many years the FDA did not regulate homeopathic drugs until in 1988, the agency issued Compliance Policy Guide 7132.15, Section 400.400 (CPG 400.400 or Policy), that established conditions under which homeopathic drugs could ordinarily be marketed without the FDA’s premarket approval, as long as the drugs complied with statutory and regulatory requirements for labeling, manufacturing, and registration. However, three decades later, as part of an ongoing effort to change the regulatory framework that applied to homeopathic drugs, the FDA withdrew CPG 400.400 in 2019.

Warning letter to MediNatura. MediNatura is a purveyor of homeopathic products, including six prescription injectable drugs that it imports from Germany. In June 2020, following the withdrawal of the CPG, the FDA sent MediNatura a warning letter asserting that its injectable products violated the federal Food, Drug and Cosmetic Act (FD & C Act), and, the agency also added the products to an Import Alert recommending that officials detain them at the border. MediNatura filed the instant lawsuit challenging the withdrawal of CPG 400.400 and the Import Alert, and sought a preliminary injunction.

Nature of the policy. The FDA moved to dismiss the lawsuit on the basis that the recission of the CPG was not subject to judicial review pursuant to the APA, because the agency’s action was not a ‘final agency action’ as required for agency judicial review, and, the policy itself did not have a ‘binding effect’ bur rather, enforcement was subject to agency discretion. The court closely examined the text of the CPG and the FDA’s implementation of the policy in order to properly characterize the policy.

Because the language of the CPG indicated that it specified the regulatory duties of manufacturers of homeopathic drugs, it therefore had legal consequences; and, the FDA’s application of the guidance to industry stakeholders confirmed that understanding. The body of the CPG stated its purpose as ‘providing guidance on the regulation of OTC and prescription homeopathic drugs and delineating those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.’ Therefore, by its own terms, the document pertained to the affirmative regulation of homeopathic drugs and not just--as the FDA claimed--to the exercise of ‘enforcement discretion’. Furthermore, MediNatura was suing to stop the withdrawal of the policy, and as a result, that would make enforcement more likely. Accordingly, the court denied the FDA’s motion to dismiss on the basis that the policy recission was not ripe for judicial review.

Challenge to Import Alert. The court next examined MediNatura’s claim that the Import Alert was procedurally invalid for failing to comply with the APA’s notice-and-comment requirements, and substantively invalid for arbitrarily determining that MediNatura’s products were unsafe. Again, the FDA oved to dismiss those claims on the ground that the Import Alert did not constitute a final agency action, rendering those claims unfit for judicial review.

The court agreed with the FDA that the Import Alert was not a final agency action, because it did not represent the culmination of the agency’s decision-making process. The placement of a product on the Import Alert must, in addition, be followed by two additional steps—detention of the imported drugs and final refusal of admission—during which the agency’s position remains unsettled. Although MediNatura cited to a press release in which the FDA expressed its plans to ‘stop these drugs from entering the U.S.,’, the court was unconvinced, on the record before it, that the FDA was so set in its position about the safety of MediNatura’s products that it would be unwilling to consider arguments to the contrary. Therefore, the court granted the FDA’s motion to dismiss on the basis that the Import Alert was not a final agency action subject to judicial review.

The case is No. 1:20-cv-02066-RDM.

Attorneys: Jason Robert Scherr (Morgan, Lewis & Bockius LLP) for MediNatura, Inc. Kathleen Braun Gilchrist, U.S. Department of Justice, for Food and Drug Administration and Department of Health and Human Services.

Companies: MediNatura, Inc.; Food and Drug Administration; Department of Health and Human Services

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