Pharma 101 - Pharmaceutical Fraud » Off-label use

Effect on Off-Label Marketing in the 2010 Budget Details?

Nolan and Auerbach — Wed, 10 Jun 2009 01:59:45 +0000

The Department of Health and Human Services recently released its budget proposal for 2010. As it relates to the FDA, HHS is looking to build

on the $1.1billion included in the recovery Act for comparative effectiveness research. The funds requested will continue efforts to produce state-of-the-science information on what medical treatments work best for a given condition.

Not only will these findings enhance medical decision-making by patients and their physicians, they will likely close the door a little bit more to the success of off-label marketing of pharmaceuticals for indications that have little to no science to back up the claims of efficacy. Physicians will hopefully have a readily available source from which to compare treatments and drugs.

Purdue Pharma Agrees to $19.5 Million Settlement Over Off Label Marketing of OxyContin

Nolan and Auerbach — Fri, 25 May 2007 16:14:53 +0000

Purdue Pharma has agreed to settle claims by 26 states and the District of Columbia for marketing and promoting OxyContin for unapproved uses i.e. for use every 8 hours as opposed to the FDA approved dosage of every 12 hours. The states alleged that FDA rules were violated by Purdue promoting OxyContin as the painkiller “to start with and the one to stay with” for numerous kinds of pain even though the drug was specifically approved a more limited use in patients who need long-term pain management. Further, the states contend that Purdue paid its sales force based on how much physicians prescribed OxyContin which led to the “misuse, diversion and abuse” of OxyContin according to Connecticut Attorney General Richard Blumenthal. Pursuant to the $19.5 million settlement, Purdue must immediately stop its off-label marketing and heed the warning label contained on its packaging.

To read more click here or more about pharmaceutical fraud at Nolan & Auerbach.

Eli Lilly and Company in More Hot Water

Nolan and Auerbach — Thu, 17 May 2007 14:25:00 +0000

Montana is the latest state to sue Eli Lilly and Company, alleging that the company improperly and fraudulently marketed Zyprexa, an antipsychotic drug for unapproved uses. According to Montana Attorney General Mike McGrath, Eli Lilly improperly promoted Zyprexa for off label use and illegally paid kickbacks to physicians. Lilly created a sales force of 280 persons according to the State of Montana complaint, “to promote Zyprexa exclusively for off-label uses, specifically for long-term-care facilities to maximize off-label use of Zyprexa sales.” Under federal laws, pharmaceutical companies are prohibited from marketing their drugs for off-label or unapproved uses. Lilly’s worldwide sales of Zyprexa were $4.36 billion in 2006.

To read more click here.

InterMune Pays Nearly $37 Million to Settle Claims for Off Label Marketing

Nolan and Auerbach — Mon, 30 Oct 2006 15:10:10 +0000

InterMune Inc., a Brisbane, California, biopharmaceutical company, has agreed to pay the government $36.9 million to resolve criminal charges and civil liabilities in connection with allegations of illegally promoting Actimmune for treatment of idiopathic pulmonary fibrosis (IPF) or lung scarring despite not receiving approval for such treatment by the U.S. Food and Drug Administration. This settlement resolves allegations that InterMune caused the submission of false claims for Actimmune that were not eligible for reimbursement because they were for unnecessary or off label uses. The FDA had approved Actimmune for treating immune system disorders.

For more information please click here.

$30 Million Off-Label Case

Nolan and Auerbach — Sun, 06 Aug 2006 16:28:44 +0000

The State of Mississipi has filed a sweeping lawsuit against the pharmaceutical company Eli Lilly (see www.lilly.com) alleging the pharmaceutical compay illegally marketed Zyprexa (an antipsychotic drug) for off label uses, thereby defrauding the state of Mississippi in excess of $30 million. For more information, click here.