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”; this statutory language is often referred to as the “mode” or “mechanism-of-action” clause.

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 mechanisms, the mode-of-action clause sets forth a category of products that FDA must classify and regulate as a medical device.

Since 2017, FDA has classified Genus’s “Vanilla SilQ” line of diagnostic contrast agents as drugs, while recognizing that the products could also satisfy the statutory definition of a medical “device.” Vanilla SilQ is a line of barium sulfate oral solution contrast agents used in radiographic procedures to enhance the image and allow a more effective diagnosis. In the case at hand, FDA’s Office of Combination Products said Genus’s Vanilla SilQ products meet the definitions for both a device and a drug, and argued FDA thus has discretion to regulate the product as either. Genus challenged this designation, asserting that Vanilla SilQ should be regulated as a device because it does not achieve its primary intended purposes through chemical action in or on the body or through being metabolized.

In siding with Genus, the majority opinion found that “FDA made no factual findings with respect to Vanilla SilQ except that it is an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease,” which are “the minimum findings necessary for classification as a drug.” The court said FDA failed to consider whether Vanilla SilQ also satisfies the device definition, and ruled that the FDCA does not grant FDA discretion to classify as a “drug” any product meeting the statutory definition of a “device.”  The opinion cited FDA’s September 2017 final guidance that said products may be classified as devices even if they are not “instruments” or “apparatuses”; for example, “gels or powders put on the skin” may be classified as devices. The court thus vacated FDA’s decision to classify Genus’s product as a “drug,” and remanded the issue to FDA to adequately assess how the Vanilla SilQ should be classified.

This decision will work to limit FDA’s discretion moving forward, and it requires that FDA regulate as a device any product that “does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.” This may benefit some medical product sponsors, as the regulatory costs to manufacturers are lower if FDA decides to regulate the product as a medical device rather than a drug requiring FDA marketing approval.

On the other hand, the decision leaves FDA with the discretion to determine regulatory classifications "in close cases," and to justify the regulation of any product as a "drug" by undertaking a fact-based, scientific analysis to determine whether that product fits into the definition of "device." FDA may continue to classify and regulate as a drug any product that it determines to achieve its primary intended purpose through "chemical action" and when it is “dependent on being metabolized,” or any product that it finds to be an "article" but not an "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory.”

The decision is not expected to have any impact on FDA’s administrative discretion to regulate drug-device combination products under single marketing application. For example, with drug products that include a delivery system such as an autoinjector, FDA’s policy continues to be to review and approve the drug and device components under a single application, usually an NDA or a BLA, with CDER taking lead review and CDRH consulting on the device-related aspects of the application. In such cases, however, the sponsor typically must abide by the combination product requirements in 21 CFR Part 4 related to product manufacturing and safety reporting. Notably, in recent years, FDA seems to have widened its lens of what constitutes a combination product, with container systems – previously regulated purely as container components of the drug – now being reframed as device constituent parts of a combination product. The Genus decision may, if anything, accelerate this trend.

If you have any questions on how FDA may regulate a certain product, or on approval standards for drugs and medical devices more generally, please contact any of the authors of this alert or the Hogan Lovells attorney with whom you generally work.

Authored by Heidi Gertner, Randy Prebula, and Jason Conaty