What’s the Hang-up? Apotex Sues FDA Over Compliance Failure That’s Stalling ANDA Approvals

By Kurt R. Karst –      

Those of us who work in the drug approval world know that a high degree of coordination among various FDA components is necessary for a smooth and efficient approval process.  This is particularly true for ANDA generic drug approval, where the Office of Generic Drugs (“OGD”) must coordinate with the Office of Compliance to, among other things, schedule facility inspections (domestic and foreign) and close all inspectional issues.  OGD will not approve an ANDA unless the Office of Compliance has given a clean bill of health for the facilities covered under the application.  In recent years, coordination between OGD and the Office of Compliance seems to have broken down.  These days it is not uncommon that OGD is in a position to approve an ANDA, but for clearance from the Office of Compliance on a manufacturing facility covered under the ANDA.  Sometimes it is merely a paperwork exercise, and sometimes more is involved.  Well, one company has said “enough!” 

Earlier this week, Apotex Inc. and Apotex Corp. (collectively, “Apotex”) filed a Complaint against FDA in the U.S. District Court for the District of Columbia seeking declaratory and injunctive relief for FDA’s alleged failure to confirm that an Apotex facility that manufactures drug for two pending applications – ANDA Nos. 201505 and 200832 – for generic versions of the popular blood pressure-lowering drugs AVALIDE (irbesartan/hydrochlorothiazide) Tablets and AVAPRO (irbesartan) Tablets operates in conformance with current Good Manufacturing Practice.  According to Apotex, both ANDAs were ready for approval on September 27, 2012 when 180-day exclusivity expired.

Apotex states in its filing that FDA (or, more specifically, the Office of Compliance) has failed to clear the facility:

despite the fact that such compliance recommendations were made for other recently approved Apotex ANDAs that rely on this manufacturing facility, including one that was approved just last week on September 25, 2012.  FDA’s unreasonable delay is in part due to its inability to locate an inspectional report that the agency should have long-since created and reviewed.  By failing to provide this compliance confirmation, Defendants are depriving Apotex of its right to have two pending ANDAs treated the same way that FDA has treated several other, similarly situated ANDAs.

Apotex’s two-count Complaint alleges that FDA’s actions violate the Administrative Procedure Act (“APA”) “because those actions have denied Apotex approval for ANDAs 201505 and 200832 for no reason other than FDA’s inability to process necessary paperwork” (5 U.S.C. § 706), and that “FDA owed Apotex a specific duty to approve those ANDAs when 180-day exclusivity expired” (28 U.S.C. § 1361, mandamus). Apotex seeks, among other things, an interim order directing the Office of Compliance to immediately issue a compliance recommendation to OGD for ANDA Nos. 201505 and 200832, and an orANDAs.  der directing OGD to immediately approve the applications.  Apotex also wants preliminary and permanent relief enjoining FDA “from withholding a compliance recommendation for any Apotex ANDA that relies on facilities that FDA has found to be acceptable in that the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are adequate to assure and preserve its identity, strength, quality, and purity.”

This is certainly a case to watch, although it could be a non-event if FDA promptly acts on the Apotex ANDAs.