Is it a Drug or Device? Court Requires FDA to Explain Itself

September 26, 2012

By Jennifer M. Thomas & Anne K. Walsh –  

Yesterday, in a big win for industry, District Court Judge Rosemary Collyer granted French company PREVOR’s Motion for Summary Judgment in a case challenging FDA’s decision to regulate PREVOR’s Diphoterine® Skin Wash (“DSW”) product as a drug.  The original Complaint was discussed in an earlier blog post here, and the briefs for all parties are available here, here, here, and here.  PREVOR was represented by Hyman, Phelps & McNamara, P.C. (attorneys Jeffrey N. Gibbs, John R. Fleder, Jennifer M. Thomas, and Anne K. Walsh).  Kudos also to the amici curiae, including the Washington Legal Foundation, Alcoa, and Archer-Daniels-Midland Company.  The case has been closely followed by industry because it involves a new FDA interpretation of the laws concerning combination product classification, as set out in an FDA classification ruling specifically applicable to PREVOR’s product and in two hotly debated draft guidance documents, available here and here (Docket No. FDA-2011-D-0429).

DSW is a “first response” method to help prevent and minimize chemical burn injuries due to accidental chemical exposures, and has long been marketed as a medical device in Europe, Canada, Brazil, and Australia.  FDA’s Office of Combination Products (“OCP”), however, classified DSW as a drug-device combination product with a drug primary mode of action, and determined that it should be regulated by the Center for Drug Evaluation and Research.  The Agency’s Office of Special Medical Programs (“OSMP”) confirmed that classification.  The D.C. District Court disagreed, and determined that both OCP and OSMP employed a new standard (“at least in part” or “even in part”) in reaching its decision.

In her 18-page opinion, Judge Collyer concluded that FDA acted arbitrarily and capriciously.  Specifically, the Court found that FDA had failed to provide a reasoned basis for its classification decision, stating that its “ipse dixit cannot substitute for the ‘qualitative analysis’ or ‘scientific information’ on which FDA says it acted.”  Instead of scientific analysis, the Court opined, FDA substituted “extraordinarily expansive language” in making its classification decision.  And it did so, without offering “more than its say-so.” 

The Court rejected FDA’s contention that the standard it applied was not new, citing the June 2011 guidance documents as evidence, and noting that the agency “fails to cite a single prior instance in which it has applied an ‘even in part’ standard.”  The Court also adopted PREVOR’s comparison to similar products treated as devices, and characterized FDA’s attempt to distinguish those products as “a most ephemeral distinction.”  

The Court questioned “[w]hether FDA would come to the same conclusions without resort to its extra-statutory interpretations.”  It vacated FDA’s decision to designate DSW as a drug-device combination product with a drug primary mode of action, and remanded the case to FDA to make a determination in compliance with its Opinion.