FDA Withdraws Appeal in the Depomed Case

By Michelle L. Butler –

We previously reported that FDA had filed a notice of appeal in Depomed Inc. v. U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592.  In another turn of events, on November 6, 2014, FDA filed an unopposed motion to dismiss the appeal.  The motion was granted and the appeal was dismissed by the Court of Appeals for the D.C. Circuit on November 7, 2014.  The Order from the Court of Appeals was docketed in the District Court’s docket on November 10, 2014. 

Apparently FDA has decided it will operate its orphan drug program within the strictures of the Depomed decision.  What effect this will have on other aspects of the program remains to be seen.