The US District Court for the District of Columbia recently ruled that the US Food and Drug Administration (“FDA”) exceeded its authority when it regulated a contrast agent as a drug instead of a medical device. In overturning the FDA’s decision, the court noted that the agency “does not have discretion to regulate all contrast agents uniformly, irrespective of their defining features under the statute.”
The suit centered around Genus Medical Technologies’ Vanilla SilQ contrast agent. Vanilla SilQ is a radiopaque barium sulfate liquid suspension that is used as a contrast agent for radiographic studies. Genus took the position that Vanilla SilQ should be regulated under the medical device pathway as it meets the requirements that the contrast agent is “intended for use in the diagnosis of disease or other conditions,” and “does not achieve its primary intended purpose through chemical action within … the body of man … and which is not dependent upon being metabolized for the achievement of its primary intended purpose.” In support of its position, Genus noted that Vanilla SilQ is inert and does not chemically interact with cells or tissues to serve its purpose, “[i]ngesting it does not affect the chemical bonds or molecular structure” of the gastrointestinal tract, and is “ ‘neither absorbed nor metabolized’ by the body.”
The FDA, on the other hand, took the position that Vanilla SilQ meets the definitions of a drug as it is ”intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man.” The FDA conceded that Vanilla SilQ also meets the definition of a medical device, but argued that the agency has the “discretion to decide how to regulate a diagnostic product that falls within both categories.” The FDA also argued that some contrast agents only meet the definition of drugs, and that it has the discretion to regulate all contrast agents, even those that meet both of the definitions of drugs and devices, “as drugs for the sake of uniformity.”
However, the court was not persuaded by the FDA’s argument. Rather, it noted that adopting the position that the contrast agent is a drug, even though it meets the definition of a medical device, “would read out the exclusionary clauses altogether,” and that this would be contrary to well-established tenets of statutory interpretation that require that all statute provisions have an effect. The court concluded “[i]f a product that meets both definitions is nonetheless treated as a drug, then the device-drug distinction would be rendered meaningless. Put otherwise, the FDA could classify any diagnostic device as a drug because no limiting principle would trammel its authority.”
To date, the FDA has not commented on the ruling, and it is not clear if the agency will appeal the decision.