Background

The Federal Food, Drug, and Cosmetic Act (FDCA) defines both drugs and devices as products “intended for use in the diagnosis of disease or other conditions,” in the “cure, mitigation, treatment, or prevention of disease,” or “to affect the structure or function of the body of man or other animals.” However, the FDCA states that a medical “device” does not achieve “its primary intended purposes through chemical action within or on the body of man,” and “is not dependent upon being metabolized for the achievement of its primary intended purpose.” In other words, while there is overlap in the statutory definitions of the purposes of a “drug” and a “device,” the way the device achieves its intended benefit is different and, when a product does not achieve its primary purpose by these defined drug-specific mechanisms, the mode-of-action clause sets forth a category of products that FDA must classify and regulate as medical devices.

Recognizing this statutory distinction, the majority opinion of the U.S. Court of Appeals for the D.C. Circuit in Genus Medical Technologies LLC v. U.S. Food and Drug Administration (summarized online here), recently ruled 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.”

FDA invites comments on best practices for drug/device transition process

FDA decided not to appeal the Genus decision and on August 9, 2021, published a notice and request for information regarding its process for ensuring future classification decisions for drugs and devices comply with the Genus opinion, and for ensuring that previously classified products fall into line with Genus. FDA said it “intends to establish a process for the orderly and efficient determination of which products currently regulated as drugs must be regulated as devices under Genus.”

In the notice, FDA said it “expect[s] the determining factor in many cases to be whether the product achieves its primary intended purposes through chemical action within or on the body or is dependent upon being metabolized for the achievement of its primary intended purposes.” The agency noted it will also “examine whether other statutory provisions—beyond the drug and device definitions—indicate Congress intended a type of product to be regulated under either the drug or device authorities.”

FDA expresses concern in the notice that the transitioning of some approved products from drug status to device status may “disrupt the supply of these important medical products or place undue burden on manufacturers or on the healthcare delivery system.” Accordingly, FDA invites stakeholders to comment on the categories of products currently regulated as drugs that may be required to transition to device status under Genus. FDA also invites comments on statutory provisions [other than the drug and device definitions] that may indicate Congressional intention regarding the appropriate regulatory pathway (i.e., drug or device) for certain types of products.

The notice also requests comments on the timing of the transition process, acknowledging that there are differences between the drug regulatory requirements and the device regulatory requirements, and that sponsors of transitioning marketed products will need time to transition from compliance with one to the other. For example, sponsors of transitioning products may need to update labeling, bring facilities into compliance with quality system regulations, and prepare for device inspections. Thus, stakeholders are invited to comment on timelines necessary for this transition, as well as the timelines for the corresponding user fee transitions. Because user-fee deadlines for drugs and generics are approaching, FDA says firms should pay those fees now and ask for a refund after the transition.

Imaging agents

Some medical imaging techniques – such as ultrasound, computerized tomography (CT), magnetic resonance imaging (MRI), and traditional radiology – can depend solely on an imaging device to produce and display images. However, imaging agents (like the one in question in Genus) are sometimes used in conjunction with these imaging devices to provide image enhancement.

Historically, FDA stated that it has 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. Now, due to the Genus decision, FDA said it will 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.

Next steps

FDA said it plans to publish a list of approved drug products that the agency tentatively determined should transition to device status under Genus. After this preliminary list is released, stakeholders will have an opportunity to comment before classification determinations are finalized.

Comments on the notice are due October 8. If you have any questions on how FDA may regulate a certain product, or may wish to submit a comment on the Genus notice, please contact any of the authors of this alert or the Hogan Lovells attorney with whom you generally work.

Authored by Randy Prebula, Heidi Gertner, and Jason Conaty