Amphastar files suit over heparin shipments

Amphastar Pharmaceuticals Inc. (Rancho Cucamonga, Calif.) filed a complaint in the U.S. District Court for the District of Columbia seeking to require FDA to release two detained U.S. shipments of semi-purified heparin imported from the company's subsidiary in China. Amphastar claimed that without the raw heparin, the company cannot begin the procedure to qualify its subsidiary as a supplier of raw material related to generic anticoagulant enoxaparin, for which FDA is reviewing an ANDA. Amphastar claimed FDA's detention of the shipments is "unlawful" and reflects a "broader pattern of arbitrary, capricious and vindictive behavior" against the company by the agency.

Last year, Amphastar submitted a complaint to FDA requesting that CDER Director Janet Woodcock recuse herself from the review process for generic versions of enoxaparin due to a conflict of interest. In February, FDA's Office of Chief Counsel and the HHS Inspector General concluded there was no conflict of interest but noted that Woodcock had voluntarily recused herself. ...