FDA Illegally Regulates Some Devices as Drugs: Attorney

Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA regulation of some medical devices as drugs violates the distinction Congress has drawn between the two regulatory schemes. “FDA’s position that it may regulate devices as drugs is plainly not authorized under the Federal Food, Drug, and Cosmetic Act (FFDCA),” Shapiro writes in his firm’s FDA Law Blog. “FDA should act promptly to bring itself into conformity with the statute.”

In his analysis, Shapiro cites FDA’s regulation of barium sulfate, a radiological contrast agent, as a drug, along with over-the-counter skin protectants such as petrolatum. In each instance, he says, the products do not achieve their primary intended purpose through chemical action on or within the body or via metabolization, as is required for a drug.

He says the agency’s core argument is that the law’s definitions for a drug and a medical device are not mutually exclusive and thus the law does not prevent all devices from being drugs. While the FDA position arguably comports with the literal words of the drug and device definitions, Shapiro says, once one steps back and looks at the big picture, it is not supported by the basic scheme and operation of the FFDCA and is even contradictory to it.

“If a product is within the definition of a device,” he writes, “Congress has decreed that it must be regulated under the device authorities. This is so even when it would be administratively convenient to do otherwise. Only an amendment to the FFDCA could give FDA the authority it claims.”