When is a drug really a device? Court knocks down FDA appeal in trying to sort that grey area
It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.
But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.
The case is a tricky one, as the appeals court even acknowledges in a footnote, “We note that it is not immediately obvious to us how a contrast agent satisfies” one of the FDA’s medical device definition’s requirements. But the court knocked down the notion that if, as FDA claims, a medical product satisfies the statutory definitions of both a “drug” and a “device,” the FDA has broad discretion to regulate the product under either category.
The questionable product in this case is barium sulfate, which works by coating an individual’s esophagus, stomach, or intestines so that physicians can more clearly see areas on a CT scan or X-ray exam. Genus took the argument that barium sulfate can’t be a drug because its “primary intended purposes” are not “through chemical action within or on the body,” whereas the FDA said the products should be classified as drugs “because they are articles intended for use in the diagnosis of disease.”
FDA’s Office of Combination Products, which is officially responsible for providing a formal, binding determination on a product’s classification, said Vanilla SilQ products appeared to meet both the definitions for a device and a drug, although the agency said it wanted to uniformly regulate all contrast agents as drugs.
That initial decision would’ve proved costly for Genus as it’s considerably more expensive to market a drug than a device. The company told the court that seeking device clearance for Vanilla SilQ would cost about $60,000, whereas if it were a drug, Genus said it would cost more than $500,000 to obtain pre-market approval, in addition to a recurring, annual cost of more than $186,000 to keep marketing the products.
Genus then sued FDA in district court in 2019, and later that year, the court ruled in favor of Genus, concluding that the plain language of the Food, Drug, and Cosmetic Act “unambiguously requires that ‘a product that meets the device definition must be regulated as such.’”
The court hearing FDA’s appeal this year, meanwhile, points to the agency’s guidance from 2017 noting that products that may not exactly be instruments or apparatuses still may be classified as devices. For instance, “gels or powders put on the skin” come within the instrument clause when used “as a barrier,” gases can satisfy the clause when “used as space fillers,” and some liquids qualify as devices when “used to clean either surgical instruments or contact lenses,” the court noted.
In siding with Genus, the appeals court also said the agency didn’t go far enough in explaining its decision. “The FDA is not entirely wrong that the drug and device definitions overlap — they do, in part. But it fell short in neither acknowledging the detailed instrument clause nor providing a lawful and nonarbitrary explanation of whether and how regulating Vanilla SilQ as a drug accords with both that clause and the mode-of-action exclusions in the device definition.”
Attorneys at Hyman, Phelps & McNamara, which represented Genus, said the decision has “wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products. The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug.”