FDA Releases Detained Shipment After Company Brings Suit

Nov 19, 2010   

November 18, 2010

Last week, Amphastar filed a Notice of Withdrawal, voluntarily dropping its Motion for a Preliminary Injunction in the Companys suit against the FDA. The Motion, which was filed just eight days earlier, concerned the detention of two shipments from Amphastars foreign-manufacturer. The two shipments detained by the FDA contained semi-purified heparin, an intended starting material, for which the Company needs to complete the FDAs qualification process. To secure approval from the FDA, the Company must get the raw material and its source approved before they are able to move forward. Because Amphastar needed these materials released in order to ultimately gain FDA approval, the Company sought injunctive relief to secure the release of the shipments.

The Motion raised serious issues as to the appropriateness of the detention. According to the Motion, while the first shipment was initially released by an FDA Customs Officer after samples had shown no contamination, the FDA rescinded the release. Citing a “mistake,” the Agency reopened its investigation and again detained the shipment. The FDAs basis for detaining the heparin was two-fold. First, the FDA notified Amphastar that the heparin was misbranded because the packaging lacked “adequate directions for use.” Second, the FDA informed the Company that the foreign-manufacturer of the heparin was not registered with the Agency
While Amphastar refuted these allegations in the Motion, the FDA soon responded by releasing the detained materials. Because Amphastar obtained the relief they were ultimately seeking, the Company voluntarily withdrew their motion. Interestingly, this is not the first time the FDA has released shipments after legal action has been taken against them. Rather, it is becoming more common to see the Agency release shipments after the legality of their detentions are challenged in court.

Last year, as lead counsel for Seagate, we successfully obtained the release of detained shipments by bringing suit and challenging the legality of the FDAs actions. Under circumstances similar to Amphastars situation, the FDA detained a series of shipments being imported into the country without alleging that the specific products were contaminated. After several unsuccessful communications with the FDA, the company attempting to import the products decided to pursue legal action. As Seagates lead counsel, we brought suit against the FDA, challenging the legality of the detention and seeking injunctive relief. Just weeks after the suit was filed, the Agency “voluntarily” released the detained shipments and removed the Import Alert that it placed on these products. For more details about this suit, the Complaint can be found here.

This pattern of detention and release upon being challenged in court is not new. As far back as 2007, while serving as lead counsel for Allied, we were able to secure the release of detained entries by bringing action against the FDA. Allied sought our help after several of its shrimp entries were detained upon arrival and the FDA refused to release the shipments. Despite receiving test results showing the shipments were not contaminated and were compliant with FDA standards, the Agency would not budge until formal action was brought to challenge their practices. However, after we brought suit to challenge the detention, the FDA quickly released the shipments. The Complaint can be accessed here. Because a trend has developed with the FDA releasing detained products as a response to being challenged in court, it appears that the Agency is more willing to cooperate with companies after formal action is taken against them.

For more information on FDA enforcement measures or import compliance, please contact us at contact@fidjlaw.com.