FDA Issues Post-Depomed Policy Statement; Agency Doubles Down on Clinical Superiority Requirement

December 22, 2014

By Kurt R. Karst & Michelle L. Butler –       

Ever since FDA withdrew a notice of appeal in Depomed Inc. v. U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592, to the U.S. Court of Appeals for the District of Columbia Circuit (see our previous post here), rumors were swirling that FDA was working on a statement to clarify how the Agency would proceed with administering its orphan drug regulations in a post-Depomed world.  Indeed, the Agency was working on something.  In a notice, styled as a “clarification of policy,” that will be published in the Federal Register on December 23, 2014, FDA addresses the effects of the Depomed court decision.  But FDA’s “clarification” is likely not what most folks were expecting. 

As we previously reported, on September 5, 2014, the U.S. District Court for the District of Columbia granted Depomed Inc.’s (“Depomed’s”) Motion for Summary Judgment in a lawsuit initiated with a September 2012 Complaint (see our previous post here) and ordered FDA to recognize orphan drug exclusivity for GRALISE (gabapentin) Tablets “without requiring any proof of clinical superiority or imposing any additional conditions on Depomed.”  The District Court found that “the plain language of the exclusivity provisions of the Orphan Drug Act requires the FDA to recognize exclusivity for any drug that the FDA has designated and granting marketing approval.” 

At the time, we thought the decision could have far-reaching implications for FDA’s orphan drug program (and perhaps beyond).  Indeed, we laid out a bunch of potential issues in a prior post.  But FDA, in the Agency’s “clarification of policy,” pushes all of these concerns to the side (at least for now).  In short, FDA says that the U.S. District Court for the District of Columbia’s decision in Depomed is limited to GRALISE.  As such, the Agency will continue to apply its clinical superiority regulatory paradigm insofar as orphan drug exclusivity is concerned.  Specifically, FDA states:

In consideration of any uncertainty created by the court’s decision in Depomed, the Agency is issuing this statement.  It is the Agency’s position that, given the limited terms of the court’s decision to GRALISE, FDA intends to continue to apply its existing regulations in part 316 to orphan-drug exclusivity matters.  FDA interprets section 527 of the FD&C Act and its regulations (both the older regulations that still apply to original requests for designation made on or before August 12, 2013, as well as the current regulations) to require the sponsor of a designated drug that is the “same” as a previously approved drug to demonstrate that its drug is “clinically superior” to that drug upon approval in order for the subsequently approved drug to be eligible for orphan-drug exclusivity.

In essence, FDA is doubling down on its pre-Depomed regulations.  Perhaps this out-of-left-field-strategy is FDA’s way of drawing out another lawsuit from an affected sponsor so that the Agency can have another crack to relitigate the issue in court.  We’ll see.