KV Pharmaceutical genitourinary news

FDA filed a reply brief in the U.S. Court of Appeals for the District of Columbia Circuit to KV's appeal of a lower court's dismissal of a suit over the company's preterm birth drug Makena hydroxyprogesterone caproate. KV alleged that FDA's policy of non-enforcement for compounded hydroxyprogesterone caproate products violated KV's right to market exclusivity for Makena under the Orphan Drug Act. In its reply, FDA said that the U.S. District Court for the District of Columbia correctly dismissed KV's suit under the U.S. Supreme Court's ruling in Heckler v. Chaney, which states that "an agency's decision not to prosecute or enforce is a decision generally committed to an agency's absolute discretion." The agency said it has not violated the terms of the Orphan Drug Act and that "section provides no guidelines for how FDA should exercise enforcement discretion."

In its appeal, KV asserted a new claim that FDA must block every imported shipment of API of hydroxyprogesterone caproate on the ground that it is an unapproved drug. FDA said that KV's claim flounders on "Congress's clear intention to allow compounding of drugs from imported" API. The appeal is not yet scheduled for oral argument. ...