Prevor v. Food & Drug Admin

• Decision Date: 25 September 2012
• Docket Number: Civil Action No. 11–1187 (RMC).
• Citation: 895 F.Supp.2d 90
• Parties: PREVOR, Plaintiff, v. FOOD AND DRUG ADMINISTRATION, Defendant.
• Court: U.S. District Court — District of Columbia

895 F.Supp.2d 90

PREVOR, Plaintiff,

v.FOOD AND DRUG ADMINISTRATION, Defendant.

Civil Action No. 11–1187 (RMC).

United States District Court,

District of Columbia.

Sept. 25, 2012.

John Robert Fleder, Anne K. Walsh, Jeffrey N. Gibbs, Jennifer M. Thomas, Hyman, Phelps & McNamara, P.C., Washington, DC, for Plaintiff.

John William Medford Claud, U.S. Department of Justice, Consumer Protection Branch, Washington, DC, for Defendant.

Eric P. Gotting, Keller & Heckman, LLP, Washington, DC, (amicus curiae) for Alcoa, Inc. and Archer-Daniels-Midland Co.

Richard A. Samp, Washington Legal Foundation, Washington, DC, (amicus curiae) for Washington Legal Foundation.

OPINION

ROSEMARY M. COLLYER, District Judge.

PREVOR, a French company, developed a product called Diphoterine™ 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.

I. FACTS

A. DSW

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 odorless 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.

B. Statutory Framework

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. See21 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”).¹See21 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 therapeutic effects of the combination product.

21 C.F.R. § 3.2(m).

For those combination products whose primary mode of action is that of a drug, the Center for Drug Evaluation and Research (“CDER”) has jurisdiction. See21 C.F.R. § 3.4(a)(1). For those combination products whose primary mode of action is that of a device, the Center for Devices and Radiological Health (“CDRH”) has jurisdiction. See21 C.F.R. § 3.4(a)(2). Assignment to a specific agency component will determine the regulatory requirements for that product and the cost of approval. See Definition of Primary Mode of Action of a Combination Product, 70 Fed.Reg. 49,848, 49, 849 (Aug. 25, 2005) (codified at 21 C.F.R. pt. 3) (“The purpose of the Office of Combination Products is to ensure the prompt assignment of combination products to agency components, the timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of combination products.”).

C. FDA Classification of DSW

On August 13, 2009, PREVOR submitted a Request for Designation (“RFD”) to the Office of Combination Products (“OCP”) at FDA, requesting that it “confirm that DSW is a device to be regulated by the Center for Devices and Radiological Health.” AR 001. Alternatively, PREVOR asked that if the Office of Combination Products determined DSW to be a combination product, “OCP confirm that DSW should be regulated as a device by CDRH.” Id. PREVOR informed FDA that 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. With its Request for Designation, PREVOR included summaries of two studies that “were conducted to compare and quantify the relative contributions of the physical/mechanical effect and the chemical effect of DSW in achieving its intended use.” Id. at 005. PREVOR also described products that the Center for Devices and Radiological Health regulates as devices “that have similar modes of action to DSW.” Id. at 008.²

On October 16, 2009, the Office of Combination Products sent a letter to PREVOR designating DSW as a combination product assigned to the Center for Drug Evaluation and Research for regulation. Id. at 675. The Office of Combination Products concluded:

The liquid appears to have two primary intended purposes: to wash the chemical off the skin and neutralize the chemical that is on the skin. Since this liquid achieves its primary intended purposes, at least in part, through chemical action, it does not meet the definition of device. The liquid does, however, meet the definition of drug at section 201(g) of the Act (21 U.S.C. 321(g)). Accordingly, we have concluded that the liquid is a drug.

Id. at 676. The Office of Combination Products also concluded that the pressurized canister that delivers the DSW solution constitutes a device. Thus, “because the product is comprised of both drug and device constituent parts,” the Office of Combination Products determined that DSW is a combination product. The Office of Combination Products also determined that the drug constituent part of DSW “provides the greater contribution to the overall therapeutic effect of the combination product and, thereby, the product's PMOA,” so it assigned DSW to the Center for Drug Evaluation and Research. Finally, the Office of Combination Products rejected the comparison...