2010 a record year for FDA fines, forfeitures

Share this article:
During fiscal year 2010 the federal government won a record $3 billion-plus in fines, forfeitures and related actions against drug firms and other FDA-regulated companies, plus more than twice as much in restitutions and profit disgorgement.
In fact, since last January, the Department of Justice's Office of Consumer Litigation, which brings cases for violations under the Food, Drug and Cosmetic Act, has successfully pursued cases resulting in 25 criminal convictions, it says.
The cases involved such matters as the unlawful marketing of drugs and devices, fraud on FDA, and adulterated product distribution.

Additionally, Justice garnered $3 billion in civil settlements and judgments in cases involving fraud against the government in FY 2010, the department says. “This includes $2.5 billion in healthcare fraud recoveries —the largest in history—and represents the second largest annual recovery of civil fraud claims,” it says.

“Moreover, amounts recovered under the False Claims Act since January 2009 have eclipsed any previous two-year period with $5.4 billion in taxpayer dollars returned to federal programs and the Treasury. Recoveries since 1986, when Congress substantially strengthened the civil False Claims Act, now total more than $27 billion.” Most of the cases resulting in recoveries were whistleblower actions under the False Claims Act, Justice says. “Of the $3 billion in settlements and judgments obtained in fiscal year 2010, over $2.3 billion was recovered in lawsuits filed under the False Claims Act's qui tam provisions. Under these provisions, whistleblowers (known as "relators") — many of whom face considerable personal risk in coming forward with allegations of fraud — are entitled to recover between 15 and 30% of the proceeds of a successful suit. In fiscal year 2010, relators were awarded $385 million. Since 1986, when the qui tam provisions were strengthened by Congress, recoveries in qui tam cases have exceeded $18 billion, and relators have obtained more than $2.8 billion in awards.”
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

Click the above link to access the complete Digital Edition of the October 2014 issue of MM&M, with all text, charts and pictures.

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets

Private View: New ways to engage with customers

Private View: New ways to engage with customers

These healthcare social media campaigns successfully use emotion, altruism and the human desire to "brand" oneself to get customers engaged.