DOJ To Expand Use Of False Claims Act To Manufacturing And AER Violations
This article was originally published in The Tan Sheet
Executive Summary
Drug manufacturers that sell to the government products that do not meet specifications or that fail to report serious adverse events could face False Claims Act allegations and potentially severe penalties in the near future
You may also be interested in...
Regulatory News In Brief
OTC PPIs add blood-thinner advisory
Leiner Teetered Toward Bankruptcy As FDA Investigated Testing Fraud
Whistleblowers' allegations of stability data manipulation at Leiner Health Products prompted the firm's rapid fall from a leading provider of private-label OTC drugs and dietary supplements to a property bought by a competitor in a bankruptcy court auction
Schering Subsidiary Takes Fall For Criminal Charges Under DoJ Settlement
Schering-Plough's settlement of off-label promotion and Medicaid fraud charges with the Boston U.S. Attorney's office places criminal responsibility with a Schering shell subsidiary