Yet Another Import Issue Resolved by Filing a Lawsuit

By Dara Katcher Levy –

We previously blogged about the Amphastar lawsuit – a suit seeking declaratory judgment and injunctive relief with regard to FDA’s detention of two entries of semi-purified heparin.  Amphastar had responded to each of FDA's allegations,  however, the shipments remained detained. 

On November 5, Amphastar filed a Motion for Preliminary Injunction against FDA alleging that Amphastar was likely to succeed on the merits of its suit and that the company was suffering irreparable harm due to the continued detention of these shipments.  A week later, on November 12, Amphastar filed a Notice of Withdrawal without prejudice of its prior Motion for Preliminary Injunction on the basis that FDA had released the materials shortly after the November 5 Motion had been filed.

It is becoming increasingly common for import issues to be resolved through utilization of the courts (often, limited to initial pleadings) in order to compel cooperation from FDA.