FDA Issues Notice on Implementation of Genus Decision

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In early August 2021, the United States Food and Drug Administration (FDA) posted a Notice in the Federal Register about its implementation plan following the Genus Med. Techs., LLC v. FDA decision from the United States Court of Appeals for the District of Columbia Circuit.

The FDA has long regulated imaging agents, such as barium, as drugs (not devices) even though some imaging agents meet the definition of both a drug and device. “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.

However, in the Genus decision, the Court found that the FDA does not have discretion to regulate products that meet the device definition as drugs. The Court of Appeals found that the FDA cannot classify any product that meets the definition of a device as a drug, except for combination products: “devices must be regulated as devices and drugs—if they do not also satisfy the device definition—must be registered as drugs.”

According to the Notice, “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.” Therefore, the FDA plans to regulate products that meet both the device and drug definitions as devices, unless the statute indicates that Congress intended a different classification.

In the Notice, FDA made a commitment to trying to make “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 FDA asked for stakeholder input on what products are currently categorized as a drug that may need to be transitioned into regulation as a device, and also indicated it would likely publish a future list in the Federal Register that outlines which products it determines should make the transition.

What’s Next?

While the initial comment period expired in October, the FDA extended the period until November 30, 2021. Therefore, it is likely to be a bit longer before any additional Notices or implementation rules are made public.

In the interim, FDA noted that Sponsors of new drug applications or abbreviated new drug applications should pay the FY 2022 user fees by the due date to avoid being placed on the arrears list and incurring other penalties. However, Sponsors may request refunds for those fees in the future if necessary, and FDA anticipates refunding user fees for those products that transition from drug status to device status.

Additionally, FDA stated that there is no action needed on marketed products until the FDA notifies the product sponsors.

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