Schering-Plough Says Consent Decree Ends
1 CommentBy Ed Silverman // August 2nd, 2007 // 2:07 pm
$500 million later, the drugmaker is finally free of the shackles of the US Attorney. In a brief statement this afternoon, Fred Hassan announced the May 20, 2002, consent decree was dissolved, following a petition filed in federal court.
The decree, a legacy of former ceo Dick Kogan, involved numerous violations of FDA Good Manufacturing Practices at facilites in New Jersey and Puerto Rico, where dozens of meds are made. The problems cast a dark cloud over Schering-Plough, which was struggling with ways to replace revenue lost to generic Claritin, and hastened the end of Kogan’s stormy tenure.
The dissolution, which Fred called an “important milestone,” isn’t surprising, though. In January 2006, the drugmaker announced it had completed all 212 significant steps and 30 validation actions required by Dec. 31, 2005, under the consent decree. The FDA, by the way, didn’t oppose the petition, according to the drugmaker.
CA MD
For Schering-Plough, I believe that achieving dissolution of the Consent Decree was a piece of cake compared with attempting to comply with their Corporate Integrity Agreement.