Court dismisses KV suit against FDA

A judge in the U.S. District Court for the District of Columbia dismissed a suit from KV Pharmaceutical Co. (OCTQB:KVPHQ) against FDA over the company's preterm birth drug Makena hydroxyprogesterone caproate. KV filed suit in July alleging that the agency's policy of non-enforcement for compounded hydroxyprogesterone caproate products violated KV's right to market exclusivity for Makena under the Orphan Drug Act. Judge Amy Berman said KV's allegations relate to FDA's discretionary enforcement activities and are therefore "unreviewable claims." She said in her ruling that the "case is fundamentally an effort to get the court to direct and oversee the FDA's enforcement activities, and that it cannot do." KV could not be reached for comment (see BioCentury Extra, July 6). ...