D.C. Circuit: FDA Lacks Discretion to Characterize ‘Devices’ as ‘Drugs’

A D.C. Circuit decision, rendered last Friday, handed victory to Genus Medical Technologies (Genus) who also prevailed over the Food and Drug Administration (FDA) before the trial court. The FDA classified Genus’s line of contrast agents used in radiologic procedures including X-rays as drugs, thereby subjecting them to more regulatory approval initially and throughout the products’ lifetime than if they were classified as devices.

According to the opinion, the FDA did so despite its recognition that the products “appear” to satisfy the statutory definition for devices. Genus subsequently filed a complaint, contesting the FDA’s classification as inconsistent with the Administrative Procedure Act (APA) and the FDCA, and later secured summary judgment.

In an opinion written by Judge Karen LeCraft Henderson, the appellate panel agreed that “the text, statutory structure and legislative history of the (FDCA) make plain that the Congress did not grant the FDA such sweeping discretion.”

The court reasoned that the law’s “basic textual architecture” permits one reading only. “A product may be regulated as a drug or a device, but not both, and while a single product may simultaneously satisfy the linguistic elements of two definitions, it is not possible for the FDA to give simultaneous effect to both,” Judge Henderson wrote.

As to the FDCA’s legislative history, the court first noted that the law sets forth two distinct regulatory tracks for drugs and devices. When determining classification, the FDA is required to seek and consider experts’ opinions on the matter. “It would make little sense, then, for the Congress to have constructed such elaborate regulatory regimes — carefully calibrated to products’ relative risk levels — only for the FDA to possess the authority to upend the statutory scheme by reclassifying any device as a drug, no matter its relative risk level,” Judge Henderson said.

Judge Cornelia Pillard joined the judgment, but in a concurring opinion explained that “the majority overshoots in the other direction by insisting the statute unambiguously eliminates all overlap of the drug and device definitions.” The concurrence, nearly the same length as the majority’s 24-page opinion, explained that instead, there is partial definitional overlap.

Genus is represented by Hyman, Phelps & McNamara P.C., and the FDA by the U.S. Department of Justice and the U.S. Department of Health and Human Services.