By Kurt R. Karst –
On April 15th, Judge Ellen S. Huvelle of the U.S. District Court for the District of Columbia granted FDA’s Motion to Dismiss a Complaint filed last September by ViroPharma Incorporated (“ViroPharma”) in connection with the approval of ANDAs for generic versions of the company’s antibiotic drug of last resort, VANCOCIN (vancomycin HCl) Capsules. The Washington Legal Foundation, in an amicus brief, joined ViroPharma in its opposition to FDA’s Motion to Dismiss. ANDA sponsor Akorn, Inc. (represented by Hyman, Phelps & McNamara, P.C.) filed an amicus brief supporting FDA.
As we previously reported, ViroPharma’s Complaint alleges that FDA violated the Administrative Procedure Act (“APA”) when the Agency failed to engage in notice-and-comment rulemaking “before effectively amending its [ANDA] regulations to permit a waiver of the in vivo bioequivalence requirement based on 21 C.F.R. § 320.24 even when none of the waiver criteria of 21 C.F .R. § 320.22 are satisfied.” ViroPharma requested declaratory relief from the court, including “that the plain reading of FDA’s regulations requires an ANDA applicant seeking a waiver of the in vivo bioequivalence testing requirement to first meet one of the criteria set forth in 21 C.F.R. § 320.22,” and that a May 2008 FDA decision concerning generic PRECOSE (acarbose) – that 21 C.F.R. § 320.24 provides an independent basis for waiving the in vivo testing requirement even when none of the criteria of 21 C.F.R. § 320.22 is satisfied – constitutes an amendment to FDA’s ANDA bioequivalence regulations.
In her 11-page opinion, Judge Huvelle ruled that ViroPharma lacks standing. Will Judge Huvelle’s decision help to clear the way for FDA approval of ANDAs for generic VANCOCIN for which there are, according to ViroPharma, 11 pending applications? And will FDA now wrap-up consideration of ViroPharma’s citizen petition (detailed in Akorn’s amicus brief) and issue a response? We patiently await answers to these questions.