A federal court in the District of Columbia has determined that the Food and Drug Administration (FDA) erred when it classified a combination drug-device product as primarily a drug, thus subjecting its French manufacturer to more burdensome regulatory requirements. PREVOR v. FDA, No. 1:11-cv-01187-RMC (U.S. Dist. Ct., D.D.C., decided September 25, 2012). Thus, the court granted the plaintiff’s motion for summary judgment and vacated FDA’s decision to designate the product as “a drug-device combination product with a drug primary mode of action.”

The product, Diphoterine™ Skin Wash (DSW), was developed to mitigate chemical burns in industrial workplaces. It consists of a canister that sprays a solution at pressure on the skin to physically and mechanically remove splashes of acids and bases by washing them away. The solution of 96 percent water and 4 percent diphoterine then neutralizes and dilutes the chemicals. The manufacturer sought a request for designation from the FDA seeking confirmation that “DSW is a device to be regulated by the Center for Devices and Radiological Health.” It has been marketed outside the United States as a device since 1996 and is registered or licensed as a medical device in Australia, Brazil, Canada, and Europe. FDA concluded that the product is a combination of a device and a drug and that the drug constituent part of DSW “provides the greater contribution to the overall therapeutic effect,” thus justifying regulation as a drug.

According to the court, FDA failed to provide a “qualitative analysis” or cite “scientific information” on which it relied and stated only that “Since this liquid achieves its primary intended purposes, at least in part, through chemical action, it does not meet the definition of device.” Because the statute distinguishes drugs from devices in combination products by refer ence to a “primary mode of action,” the court agreed with the manufacturer’s argument that “FDA now prevents a device from having even a de minimus chemical effect because the ‘at least in part’ or ‘even in part’ language is so encompassing.”

In this regard, the court noted, “FDA treated any purpose of DSW as a primary intended purpose, contrary to the more limited language of the statute and the agency’s distinction between primary and secondary in prior precedent.” The court further stated, “FDA treated achievement even in part of any purpose through chemical action as achievement of a primary intended purpose through chemical action. There may be solid scientific reasons for FDA’s new approach but these remain unexplained, at least without defining ‘primary’ in a manner consistent with the law.”