After court defeat, FDA shifts to regulating some drugs as devices

Regulatory NewsRegulatory News | 09 August 2021 |  By 

The US Food and Drug Administration (FDA) is informing stakeholders and the public that it will soon begin implementing a court decision that may require the agency to transition some products approved as drugs to be regulated as devices.
In April, FDA lost a court battle (Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928) in the US Court of Appeals for the District of Columbia Circuit when it argued it had the ability as a regulatory authority to classify some barium sulfate contrast imaging agents as drugs when they also met the definition of a device under the Federal Food, Drug, and Cosmetic Act. The classification of barium sulfate contrast agents, FDA explained, was “intended to be consistent with a previous court decision” and done so the agency could regulate all contrast imaging agents under an authority in the Center for Drug Evaluation and Research.
“In the Genus litigation, both the District Court and the Court of Appeals, as a matter of statutory interpretation, disagreed with FDA’s view that the Agency had discretion to regulate products meeting the device definition as drugs,” FDA said in a recent notice published in the Federal Register. “The Court of Appeals determined that FDA cannot classify as a drug any product that meets the definition of device, stating ‘[e]xcepting combination products, ... devices must be regulated as devices and drugs--if they do not also satisfy the device definition--must be regulated as drugs.’”
In response, FDA said the US government is not appealing and will align these borderline products with the court decision. “FDA intends to regulate products that meet both the device and drug definition as devices, except where the statute indicates that Congress intended a different classification, and we further intend to bring previously classified products into line with the Genus decision,” the agency stated.
A major change in regulating imaging agents
The move is a major change for FDA because the agency has long regulated imaging agents as drugs, rather than devices, even though some imaging agents meet the definition of both a drug and a device. Imaging agents were regulated by FDA as drugs regardless of whether they serve as an enhancement for imaging devices like ultrasound, CT, MRI, and radiology devices, or are necessary to produce an image, such as in the case of radiopharmaceutical imaging.
“For the past two decades, FDA has generally regulated the imaging agents used in these procedures as drugs without consideration of whether they appear to achieve their primary intended purposes through chemical action within or on the body or whether they are dependent upon metabolization for the achievement of their primary intended purposes,” FDA said. “Following the Genus decision, we intend to reexamine whether individual imaging agents meet the device definition, including whether they achieve their primary intended purposes through chemical action within or on the body or are dependent upon being metabolized for the achievement of their primary intended purposes.”
FDA has asked stakeholders to weigh in on what products currently categorized as a drug may need to be transitioned to being regulated as a device as well as any statutory provisions for what Congress intended a product type’s regulatory pathway to be. The agency also indicated it would likely publish a future list in the Federal Register containing products it determines should make the transition.
“Implementation of the Genus decision will require FDA to transition some approved products from drug status to device status. FDA will aim to effect necessary product transitions in a way that does not disrupt the supply of these important medical products or place undue burden on manufacturers or on the healthcare delivery system,” the agency said.
Federal Register notice


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