January 18, 2007
Schering-Plough to pay $435 million in marketing, pricing case
Schering-Plough and its Schering Sales Corp. division were sentenced to pay $435 million Wednesday as part of a settlement with the Justice Department over accusations the companies engaged in off-label marketing and lied about drug prices, the Associated Press reported.
Under the settlement first announced in August, Schering Sales Corp. pleaded guilty to conspiracy and agreed to pay a criminal fine of $180 million. Parent company, Schering-Plough agreed to pay another $255 million to resolve civil aspects of the case. The sentencing ends an investigation by the Justice Department and the US Attorney’s office in Boston that began in 2001.
Federal investigators said Schering-Plough marketed drugs for uses that had not been approved by the FDA. An example was Temodar, a drug the FDA approved to treat a type of brain tumor called anaplastic astrocytoma. Prosecutors said Schering-Plough promoted Temodar to treat several other types of brain cancer, indications which the FDA had not approved. The company also promoted the unapproved use of Intron A for the treatment of cancer on the surface of the bladder, prosecutors said.
Although doctors are allowed to prescribe drugs for unapproved uses, drug companies are prohibited from marketing drugs for off-label uses.
US District Judge Patti Saris scolded Schering and the entire pharma industry for promoting non-FDA approved uses for drugs. She noted that several other major drug companies have also been fined for illegal marketing including Pfizer, which in 2004 agreed to pay $430 million on allegation that Warner-Lambert, which Pfizer acquired in 2000, promoted non-approved uses of the anti seizure drug Neurontin.
“You cannot thumb your nose at the FDA,” Saris said in the AP report. “At the end of the day, you can’t market off-label. … It’s wrong.”
Brien O’Connor, an attorney for Schering-Plough, said in the AP report that the company never lied to doctors about the uses the drugs had been approved for, but simply spoke to doctors and gave them peer-reviewer articles about other uses for the drugs. “We told the truth about Temodar and Intron and we didn’t mislead the doctors,” O’Connor said.