FDA is Sued Over Product Designation Determination; Lawsuit Seeks Device Declaration and to Vacate FDA’s Drug Findings

By Kurt R. Karst & Jeffrey K. Shapiro

French company PREVOR has filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s determination that PREVOR’s Diphoterine® Skin Wash (“DSW”) is a drug-device combination product with a “drug” primary mode of action. Hyman, Phelps & McNamara, P.C. represents PREVOR in the lawsuit.

DSW consists of a liquid substance contained inside a canister. It is intended to help prevent and minimize chemical burn injuries that occur due to accidental exposure to chemicals and is intended to be used in the industrial setting as a “first response” method. DSW is sprayed onto the skin to physically and mechanically remove or wash away the offensive chemical from the skin. A secondary purpose is to neutralize the acids and bases that are washed off the skin. The Complaint alleges that uncontradicted data show that over 90% of the overall intended purpose of the product comes from a physical washing effect, and that less than 10% of the intended purpose comes from a chemical neutralization effect.

Under the FDC Act and FDA’s implementing regulations, a product that is a “device” is generally subject to the regulatory authority of FDA’s Center for Devices and Radiological Health (“CDRH”), while a product that is a “drug” is generally subject to the regulatory authority of FDA’s Center for Drug Evaluation and Research (“CDER”). Some products, termed combination products, contain both drug and device components.

In October 2009, OCP issued a Letter of Designation to PREVOR in response to the company’s August RFD. OCP concluded that DSW is a drug-device combination in which the liquid is the “drug” constituent part and the canister is the “device” constituent part. OCP further concluded that DSW has a “drug” primary mode of action and assigned primary jurisdiction of the product to CDER for regulation. In March 2010, PREVOR requested that FDA’s Office of Special Medical Programs (“OSMP”) reconsider OCP’s October 2009 determination. More than a year later, however, on April 25, 2011, FDA’s OSMP issued a letter affirming OCP’s October 2009 determination.

The Complaint states that DSW is a liquid that meets the statutory definition of a “device,” because its primary intended purpose is not chemical, but physical/mechanical, and alleges that FDA’s jurisdictional determination is arbitrary, capricious, and contrary to law under the Administrative Procedure Act. PREVOR also alleges, among other things, that FDA “erroneously ruled that a product does not meet the definition of a device if there is any chemical action within or on the body of man in achieving its primary effect,” and that FDA’s decision “conflicts with numerous prior decisions by FDA to regulate products as devices because their primary effect is physical, despite having some chemical effect.”

PREVOR is seeking injunctive relief and a Declaratory Judgment that would vacate FDA’s finding that DSW’s solution is a “drug” and not a “device” and designation of DSW as a drug-device combination product with a “drug” primary mode of action, and thatDSW is a “device,” or, in the alternative, that DSW is a drug-device combination product with a “device” primary mode of action.