The opinion of the court was delivered by: Rosemary M. Collyer United States District Judge
PREVOR, a French company, developed a product called DiphoterineTM Skin Wash ("DSW") to mitigate chemical burn injuries in the industrial workplace. PREVOR sues the Food and Drug Administration for declaratory and injunctive relief to change FDA's designation of DSW as a drug-device combination product with a "drug" primary mode of action. PREVOR claims that FDA erred and thereby violated the Federal Food, Drug, and Cosmetic Act and the Administrative Procedure Act. FDA maintains that its determination was based on the clear language of its governing statute and was not in violation of the APA. The parties cross-move for summary judgment.
The Court concludes that FDA acted arbitrarily and capriciously in designating DSW as a drug-device combination product with a drug primary mode of action. Accordingly, the Court will grant PREVOR's motion for summary judgment and deny the cross-motion of the FDA.
PREVOR developed DSW to prevent and minimize chemical burn injuries that occur in the industrial workplace due to accidental exposure to chemicals. It has been marketed outside the United States as a device since 1996 and is registered/licensed as a medical device in Europe, Canada, Brazil, and Australia. When a water shower is not available, DSW provides an alternative "first-response" to chemical exposure. "DSW consists of a liquid substance contained in a canister propelled by pressurized gas." AR 001. The liquid substance is colorless and ordorless and is comprised of roughly 96% water and 4% diphoterine. Id. at 003. "DSW is used by spraying the pressurized contents of the canister on to the skin to physically and mechanically remove splashes of acids and bases off the skin by washing them away." Id. at 001. "DSW is intended to: (1) remove splashes of acidic or basic substances off the skin by physically and mechanically washing the chemicals away from the skin, and (2) neutralize and dilute acids and bases." Id. at 002. PREVOR states that "[t]he first use is a physical/mechanical mode of action (comprises approximately 90% of DSW's overall effect), while the second one is a chemical mode of action (comprises approximately 10% of DSW's overall effect)." Id. "Dissolution of the acids and bases has a minor, incidental effect, comprising less than 1/2 % of DSW's overall effect." Id. at 001.
The Federal Food, Drug, and Cosmetic Act ("FFDCA"), 21 U.S.C. § 301 et seq., gives FDA jurisdiction over, inter alia, the regulation of drugs and devices. The statute defines "drug" to mean, in part, "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)(1)(B) & (C). It defines "device" to mean
[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) 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) 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.
Id. at § 321(h). The critical distinguishing element applicable in this case is that a product that "achieve[s] its primary intended purposes through chemical action within or on the body" is excluded from the definition of a device.
The FFDCA recognizes that a product may be both a drug and a device, which the law labels a "combination product." 21 U.S.C. § 353(g). A combination product is defined by regulation as: "A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity." 21 C.F.R. § 3.2(e)(1). FDA considers the DSW canister/liquid solution, as a whole, to be a combination product. "PREVOR believes that DSW is a single-entity product with two modes of actions [sic] -- physical and chemical -- where the physical mode of action is primary and the most predominant in achieving the product's intended use." AR 001.
Pursuant to the FFDCA, FDA has designated agency components to regulate combination products. See 21 U.S.C. § 353(g)(1); 21 C.F.R. § 3.4. To determine which agency component will regulate a given combination product, FDA assesses a product's primary mode of action ("PMOA").*fn1 See 21 U.S.C. § 353(g)(1). Each constituent part of a combination product contributes a "mode of action" -- "the means by which a product achieves an intended therapeutic effect or action." 21 C.F.R. § 3.2(k). "A constituent part has a device mode of action if it meets the [FFDCA] definition of device . . . and it does not achieve is primary intended purposes through chemical action within or on the body of man or other animals . . . ." 21 C.F.R. § 3.2(k)(2). "A constituent part has a drug mode of action if it meets the [FFDCA] definition of drug . . . and it does not have a . . . device mode of action." 21 C.F.R. § 3.2(k)(3). A primary mode of action is defined as:
[T]he single mode of action of a combination product that provides the most important therapeutic action of the combination product. The most important therapeutic action is the mode of action expected to make the greatest contribution to the overall intended ...