Last week, the Department of Justice and the FDA announced that Janssen Pharmaceuticals has pled guilty to misleading buyers of the drug Risperdal and selling it under fabricated pretenses. Johnson & Johnson and its subsidiary, Janssen, will pay a total of $2.2 billion in settlement money.
$1.72 billion of the $2.2 billion is attributed to a civil settlement with federal and state governments. $485 million will be paid out under criminal fines and forfeitures. The U.S. Attorney General said that the United States Department of Health and Human Services Inspector General will also being enforcing a corporate integrity agreement policy for Johnson & Johnson and Janssen.
Attorney General Holder said that the conduct of Johnson & Johnson has jeopardized the health and safety of patients, as well as damaged the public trust. The "multibillion-dollar resolution," said Holder, "demonstrates the Justice Department's firm commitment to preventing and combating all forms of health care fraud…[and]…proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people."
Risperdal has been in use since 1999 and was officially approved by the FDA for treating schizophrenia and Bipolar I Disorder since 2003. Janssen has now admitted to marketing the drug to doctors for the treatment of agitation associated with elderly dementia and for the use of children from 2000 until 2004. The FDA never approved either of those uses.
The U.S. Department of Justice says that both Janssen, through Johnson & Johnson, knowingly downplayed the risks of stroke and premature death that the drug could cause in the elderly. In addition, the Department of Justice says that Johnson & Johnson paid kickbacks to doctors who prescribed the drug. It is not yet known if physicians associated with the kickbacks will face any charges or fines.
The Department of Justice's investigation of Johnson & Johnson and Janssen came after thousands of complaints and multiple tips that the companies were involved in bogus marketing campaigns, and that possible kickbacks were in play. The FDA commissioner, Dr. Margaret Hamburg, said that when pharmaceutical companies ignore the FDA's requirements, they risk endangering public safety and damaging the trust that patients have in their doctors and the medications they are prescribed. "The FDA relies on data from rigorous scientific research to define and approve the uses for which a drug has been shown to be safe and effective," said Hamburg. "Today's announcement demonstrates that pharmaceutical manufacturers that ignore the FDA's regulatory authority do so at their own peril."