By Jeffrey H. Brochin, J.D.
Congress did not grant to the FDA sweeping discretion to regulate a device as a drug where the product fell into overlapping definitions, rather, the Act unambiguously requires that a product that meets the device definition be regulated as such.
A federal appeals court in the District of Columbia has affirmed the district court’s grant of summary judgement to Genus Medical Technologies, LLC (Genus or manufacturer) in a lawsuit filed against the FDA challenging the agency’s classification of Genus’s contrast agent as a drug. The court rejected the FDA’s argument that if a medical product satisfies the statutory definitions of both a "drug" and a "device," the Act’s overlapping definitions impliedly grant the FDA broad discretion to regulate the product under either regime. The decision was based in part on the fact that the Act not only provides for different approval requirements, but also different requirements for maintaining the product after approval (Genus Medical Technologies, LLC v. FDA, April 16, 2021, Henderson, K.).
Statutory and regulatory definitions. The FD&C Act grants to the FDA the authority to regulate certain categories of medical products, including drugs, devices, biologics and dietary supplements. Relevant to the instant dispute, the Act defines "drugs" to include: articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. The Act also defines "devices" to include: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Genus’s contrast agent. Since 2015 Genus has manufactured its Vanilla SilQ product line which is a contrast agent used in medical imaging to improve the visualization of tissues, organs and physiological processes. Vanilla SilQ is used in combination with X-ray examinations to enhance the visualization of the gastrointestinal tract for diagnostic purposes. The product’s key ingredient is barium sulfate which coats the inside of the individual’s gastrointestinal tract and facilitates the absorption of X-rays.
Although some contrast agents cannot be classified as devices because they utilize metabolization or chemical action within or on the body of the patient, significantly, the FDA agreed that Genus’s Vanilla SilQ product line appeared to meet the definition of "device" insofar as it does not achieve its primary intended purposes through either of the excluded modes.
FDA classification. In June 2016, the FDA conducted an inspection of Genus’s distribution facility, after which Genus was sent a warning letter on May 2, 2017 notifying it that its products constituted "drugs" within the meaning of the FD&C Act. Genus responded to the letter asserting that its products are devices and that the FDA could not regulate them as drugs because they do not achieve their primary intended purposes through chemical action within or on the body or through metabolization. However, the FDA continued to maintain that the contrast agents should be classified as drugs, noting that "although the Vanilla SilQ products appear to meet the definition of ‘device’ they also meet the definition of ‘drug’ under the FD&C Act because they are articles intended for use in the diagnosis of disease."
Genus submitted a Request for Designation (RFD) for formal classification of VanillaSilQ as a device, but when that failed, they filed suit in district court.
Claim of statutory ambiguity. Relying on the statute’s text, the FDA argued that because it is possible for a product to simultaneously satisfy the linguistic demands of both the drug and device definitions, Congress must have granted the FDA discretion in such instance to choose a classification. Therefore, any product meeting the device definition may be classified as a device, any product meeting the drug definition may be classified as a drug and, according to the FDA’s reading, any product meeting both definitions may be classified as either. To the extent that the FD&C Act is silent on how to treat products that meet both definitions, the FDA argued that the court should read it as a sign of statutory ambiguity and defer to the FDA’s purportedly reasonable interpretation.
Basis for summary judgment. Conversely, Genus argued that because of the definitional overlap, the court should focus on the elements of the device definition that set it apart, including, most prominently, its mode-of-action clauses. Because the drug and device definitions are broadly similar except for the device definition’s mode-of-action clauses—excluding products that achieve their primary intended purposes through "chemical action within or on the body of man" or metabolization—products that do not achieve their primary intended purposes through either excluded mode must be regulated only as devices.
The court concluded that the FDA was mistaken, and that although in theory it may be possible for a product to satisfy both definitions at once, the FDA was ignoring the fact that the FD&C Act’s statutory definitions carry concrete regulatory consequences, and the Act elaborated distinct regulatory regimes for drugs and for devices. It would make little sense for Congress to have constructed such elaborate regulatory regimes 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.
For the foregoing reasons, the court affirmed the decision of the district court that granted summary judgment in favor of Genus.
The case is No.: 20-5026.
Attorneys: Douglas B. Farquhar (Hyman, Phelps & McNamara, PC) for Genus Medical Technologies LLC. Daniel Winik, U.S. Department of Justice, for U.S. Food and Drug Administration.
Companies: Genus Medical Technologies LLC; U.S. Food and Drug Administration
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