Posted by Phillipa on August 12, 2011, at 21:03:58
Never knew this is a criminal offense for a drug company to promote using meds off label. Johnson & Johnson settled a court case involving resperidone and Invega. Phillipa ps if so how can docs do it?
From Medscape Medical News > Psychiatry
Johnson & Johnson Settles Charge in Risperidone Marketing
Nancy A. MelvilleAuthors and Disclosures
August 11, 2011 Johnson & Johnson (J&J) says it has reached an agreement with the US Department of Justice on a misdemeanor charge related to the marketing of the company's antipsychotic drug risperidone (Risperdal), which went generic about 3 years ago after the company lost the patent.
In a regulatory filing with the Securities and Exchange Commission this week, the company said it has allocated an undisclosed amount for a proposed settlement of the charge.
"Discussions have been ongoing in an effort to resolve criminal penalties under the Food Drug and Cosmetic Act related to the promotion of [risperidone]," the company stated in the filing.
"An agreement in principal on key issues relevant to a disposition of criminal charges pursuant to a single misdemeanor violation of the Food Drug and Cosmetic Act has been reached, but certain issues remain open before a settlement can be finalized. The company has adjusted the accrued amount in the second quarter of 2011 to cover the financial component of the proposed criminal settlement."
Multiple Lawsuits
J&J said that the Department of Justice notified the company of its plans to intervene or join in multiple lawsuits that have been filed against the company and its Janssen Pharmaceuticals division.
The various lawsuits, which date back to 2004, allege that the company promoted risperidone and a related antipsychotic drug, paliperidone (Invega), for unapproved uses, including dementia and mood and anxiety disorders, and downplayed potential risks, according to Bloomberg News. The drugs are both indicated for schizophrenia.
The involvement of federal prosecutors in such cases typically indicates that the government is confident that millions of dollars paid for Medicare and Medicaid patients' prescriptions can be recovered, according to an Associated Press report.
Eleven states are seeking reimbursement for the Medicaid or other public funds used to pay for risperidone prescriptions. A jury in Louisiana ordered J&J to pay nearly $258 million to the state in 2010 in relation to charges of making misleading claims about risperidone's safety.
Marketing for Unapproved Indications Illegal
The company was also ordered by a South Carolina judge in June to pay $327 million in relation to deceptive marketing of the drug; however, J&J said in this week's filing that it has asked the judge to reject the verdict.
Attorneys general in about 40 other states have shown interest in possibly suing the company, and the statute of limitations has been lifted while the states "pursue a coordinated civil investigation," J&J said in its statement.
Prior to losing its patent protection about 3 years ago, risperidone generated more than $3 billion in annual sales for J&J, according to the Associated Press.
Although the off-label use of drugs is common, marketing for unapproved uses is illegal, and most major pharmaceutical companies have faced litigation for such marketing practices.
J&J says it will continue to defend itself against the allegations, and expects its challenges to the claims will help to minimize losses.
"There are significant facts in dispute, the damages sought in the claims are unsubstantiated and indeterminate, there are numerous parties involved, and possible outcomes are uncertain," J&J said in its filing.
"For these reasons, the company is unable to estimate a range of loss. However, future negotiations may lead to a narrowing of the areas of disagreement, and the liability may then become reasonably estimable in accordance with applicable accounting principles."
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