The U.S. Food and Drug Administration’s (FDA’s) definitions of drugs and devices are remarkably similar—far more similar than you would think. Both are defined 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.”

The key difference, according to the Federal Food, Drug, and Cosmetic Act (FDCA), is that a “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.”

Despite the similarities in these definitions, the FDA’s treatment of devices can vary significantly from its treatment of drugs. The net effect is that, on average, its more costly for sponsors to develop and market products as drugs than to develop and market them as devices.

Traditionally, it has been the FDA that has decided whether products brought forward for consideration are drugs or devices.

Enter Genus Medical Technologies.

Unhappy with the FDA’s classification of its line of diagnostic contrast agents as drugs, Genus sued to challenge the decision in court.

In an April 2021 decision by the U.S. Court of Appeals for the District of Columbia Circuit, the court did not overthrow the FDA’s decision regarding the Genus contrast agents. Instead, the court changed the conversation entirely, stating that Congress had not granted the FDA the right to classify products with “such sweeping discretion.”

As a result of this decision, the FDA will now treat products that meet the definition for both “drug” and “device” as devices, unless Congress exercises its right to mandate otherwise.

You can read more about the court decision here. The article includes a link to the Court’s majority opinion.

Wondering what the impact of such a decision might be on your pipeline and development plans? The Pearl Pathways team of regulatory and clinical expert advisors is well prepared to help you understand and navigate issues like this to your advantage. Let us know how we might help.