Court Rules Against FDA’s Finding That a Device was a Drug

Regulatory NewsRegulatory News | 09 December 2019 |  By 

Whether the US Food and Drug Administration (FDA) classifies a product as a drug or a device can have huge implications for the sponsor, partly because of how the agency reviews the different products and partly because of the increased cost of bringing a drug to market.

For Missouri-based Genus Medical Technologies’ contrast agent Vanilla SilQ, which people drink before undergoing an X-ray, the US District Court for the District of Columbia recently ruled that FDA made the incorrect decision and that the agent is not a drug.

Marketed since 2015 as a device, as the contrast agent is “neither absorbed nor metabolized” by the body, FDA in May 2017 sent the company a warning letter claiming that its product is actually a drug. In backing its claim, FDA said that contrast agents — which all meet the definition of drugs, but not necessarily devices — must be regulated uniformly.

But the court ruled otherwise, noting that FDA “does not have discretion to regulate all contrast agents uniformly” and because “Vanilla SilQ products, unlike other contrast agents, do not chemically interact with the body, they should be treated as devices.”

The court decision also discussed the issue of combination products and how all diagnostics technically meet the definition of a drug. “If 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,” the court said.

Genus also pointed out how the cost of seeking clearance to market a device is estimated to be $60,000, whereas drug approvals can cost more than $500,000, in addition to annual costs of more than $186,000.

“Congress’s intent was not — as the FDA would have the Court believe — to delegate unfettered discretion to the FDA to regulate all devices as drugs,” the court added in its opinion.

The Washington, DC-based law firm Hyman, Phelps and McNamara, which represented Genus, wrote on its blog: “This is a big win for industry in limiting FDA’s discretion. The decision supports the proposition that, despite some level of deference by federal courts to agencies, the plain meaning of the FDCA places strict limits on FDA’s administrative decisions, and courts will reject FDA’s administrative decisions when they run counter to clear statutory meaning.”



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