A decade later, GMP problems cost Schering-Plough another $165 million
This article was originally published in The Gold Sheet
Executive Summary
Manufacturing problems at four facilities in the late 1990s continue to haunt Schering-Plough. The company paid $165 million last month to settle a related shareholder class action. The shareholders alleged that Schering had delayed disclosure of the severity of the GMP issues and the risk that FDA would respond by holding up approval of its allergy drug Clarinex, a successor to Claritin. FDA delayed the launch by a year ("The Gold Sheet," June 2002)