July 18, 2011

Diphoterine® Skin Wash Drug Classification Results in Lawsuit

by Andrew S. Wasson

spray.jpgPrevor, a French company specializing in chemical risk management, recently sued FDA in the District Court of the District of Columbia for allegedly misclassifying its proposed product Diphoterine® Skin Wash ("DSW") as a drug-device combination with a "drug" primary mode of action. FDA's classification determines the standards for approval and which Center at FDA regulates (and ultimately controls the approval of) the proposed product. FDA's Center for Drug Evaluation and Research ("CDER") as a rule has jurisdiction over drugs and all combination products where the drug provides the primary mode of action. On the other hand, the Center for Devices and Radiological Health ("CDRH") reviews all device products and all combination products where the device provides the primary mode of action. Generally speaking, drug standards of approval are more rigorous than device standards, thus regulated industry will often attempt to characterize a product as a device rather than a drug if a choice is available.

Here, DSW is intended for use as a "first response" to accidental chemical burns occurring in an industrial setting. DSW comprises 96% water and 4% diphoterine in variously-sized canisters wherein the contents are propelled by pressurized gasses. The complaint avers that the primary mode of action is to "physically and mechanically remove or wash away" the offensive chemical. According to the complaint, this comprises 90% of the intended use. The complaint does acknowledge that DSW has a "chemical" effect as well (neutralizing acidic or basic chemicals residing on the skin), but that this chemical effect comprises only 10% of its intended use.

The complaint requests injunctive relief and a declaratory judgment: (1) vacating FDA's finding that DSW is a drug and not a device, (2) vacating FDA's determination that DSW is a combination product with a drug primary mode of action, (3) declaring that FDA's determination was arbitrary, capricious, or an abuse of discretion, and (4) declaring that DSW is a device, or at least a combination product with a device primary mode of action.

Accordingly, the definitions of "device" and "drug" are critical. For example, the Federal Food, Drug & Cosmetic Act ("FD&C Act") defines a device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory" but also places one of three limitations on such a product: (1) it must be recognized in the NF or USP, (2) it must be "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals," or (3) it must be "intended to affect the structure or any function of the body of man or other animals, and which 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." 21 U.S.C.§ 321(h). By comparison and contrast, the FD&C Act defines a "drug" as including articles recognized by official compendia, but also broadly encompassing, "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and " articles (other than food) intended to affect the structure or any function of the body of man or other animals." 21 U.S.C.§ 321(g).

The FD&C Act's definition of a term like "drug" poses an interesting case study in the relationship between legal and cultural definitions and how they inform each other. The definition of drug, for example, has undergone several revisions since the 1906 Pure Food and Drug Act, and all of them reflecting the complex relationship between its then-popular usage as well as the hoped-for usage by self-interested regulated industry. For an excellent history, see Lewis Grossman's Food, Drugs, and Droods: A Historical Consideration of Definitions and Categories in American Food and Drug Law. Looking forward, query whether the current definition of "drug" has outgrown some of its more archaic appendages (e.g., the USP requirement) or even actually makes sense (see the conjunctive use of "and").