FDA Is Pursuing Its Own Pharma Fraud Investigations; DoJ Nets $2.5 Bil. In FY 2010
One sign that the government is zealously going after the pharmaceutical industry for health care fraud is the line up of criminal investigations FDA has initiated.
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HHS and the Department of Justice note actions taken last year in their Health Care Fraud and Abuse Control Program Annual Report for fiscal year 2011; enforcement actions net a record sum.
FDA appears likely to target flagrant off-label promotion in its first cases under new procedures for using the Park Doctrine and strict liability statutes to prosecute corporate executives and others.
The company agrees to pay $422.5 million to resolve civil and criminal claims related to off-label use and kickbacks, including allegations that it paid doctors' speaking and consulting fees based upon the volume of prescriptions they wrote for its hypertension drugs.