The United States District Court for the District of Columbia, in Prevor v. FDA (Prevor II), rejects for the second time FDA’s “erroneous and unreasonable interpretation” of the definition of “device” under the Federal Food, Drug and Cosmetic Act (FDCA) (op. at 21).  The court has remanded the case to FDA to use a lawful standard in determining whether the product “does not achieve its primary intended purposes through chemical action.”

The case arose from Prevor’s second court challenge to FDA’s proposed classification of Prevor’s Diphoterine™ Skin Wash (DSW) as a “drug,” in contrast to Prevor’s belief that the product is a device.  The product consists of a pressurized canister with a liquid solution.  Prevor described the liquid solution as being intended to:  (1) wash chemicals off the skin, and (2) neutralize the chemicals on the skin.  Prevor claimed that the first use was a physical mode of action and comprises 90% of the product’s overall effect, whereas the neutralizing chemical effect was not the primary intended purpose of the product and comprises about 10% of the overall effect.  Prevor also said the product’s “purpose is to help prevent and minimize accidental chemical burn injuries.”

FDA classified DSW as a combination product that would be regulated as a drug because it depended, at least in part, on chemical action within or on the body to achieve one of its intended purposes.  This determination was consistent with the position stated in FDA’s draft guidance issued in 2011, where FDA states: “a product that depends, even in part, on chemical action within or on the body of man to achieve any one of its primary intended purposes, would not be a device.”

In the earlier Prevor I decision, the court rejected FDA’s “new expansive interpretation” of “primary” purpose to mean “at least in part” or “even in part,” which would prevent a device from having even a de minimus chemical effect.  The court criticized FDA for failing to address or explain what makes the chemical effect a “primary intended purpose” of this DSW product.  The court ordered FDA to narrow its interpretation of “primary intended purpose,” and to provide a reasonable basis for concluding that DSW’s chemical effect achieved a primary intended purpose.

On remand, FDA again classified DSW as a drug-device combination product that should be regulated as a drug.  In doing so, however, FDA asserted that the product did not have two intended purposes but only one purpose — “to help prevent and minimize accidental chemical burn injuries.”  The court found that this determination was reasonable, because Prevor had also described the product as having that purpose.   Next, the agency interpreted “achieve” in the chemical action clause to mean “meaningfully contributes to.”   Without the need to ascertain a primary purpose, FDA determined that DSW was a drug on the basis that its neutralizing action meaningfully contributes to the prevention and minimization of chemical burn injuries.

In Prevor II, the court rejected FDA’s interpretation of the term “achieve” as being contrary to the plain meaning of the word.  The court said the word “achieve” means to “accomplish or attain,” and is not synonymous with the term “meaningfully contributes to” (which requires a lesser degree of involvement, such as to help).  FDA cannot substitute a different standard from the one Congress had intended.  Although the court left the precise formulation of the standard to FDA, the court’s ruling means that FDA will be required to apply a standard that requires a greater degree of involvement between a product’s chemical action and its intended purpose than a meaningful contribution.

The impact of the case on FDA’s future classification decisions of combination products remains to be seen.  The court did not decide the ultimate question of whether DSW should be classified as a device or a drug in deference to FDA’s scientific expertise.  Nor did the court find that FDA had acted unreasonably in redefining DSW’s two primary intended purposes as one broadly defined primary purpose, even though the broader characterization allowed the agency to avoid distinguishing between primary and secondary purposes.  This result leaves open the possibility that FDA may reclassify DSW as a drug if the agency reassesses the scientific evidence under a reasonable interpretation of the device definition and reaches the same conclusion.  The court’s remand may also leave open the possibility that FDA may frame a product’s primary intended purpose in such a way that the agency may reasonably find that the product’s chemical action achieves that purpose.

Although the formulation of the precise standard is now in FDA’s hands, the court’s ruling may affect FDA’s apparent policy of favoring the regulation of drug-device combination products as drugs.  Many manufacturers have opposed this policy trend since new drugs have more stringent premarket review requirements than devices.