INDIANAPOLIS January 15, 2009, 10:56 am ET · Eli Lilly & Co. said Thursday it pleaded guilty to a charge that it illegally marketed the anti-psychotic drug Zyprexa for an unapproved use, and will pay $1.42 billion to settle civil suits and end the criminal investigation.
OK folks. Dan and I have discussed off labeled use before. There is a reason it is dangerous – no studies, no idea as to effectiveness, side effects etc. There is a reason the FDA has an approval process, and avoiding it has consequences.
So what did Lilly do wrong? The Federal Government alleged (and they plead guilty) to promoting Zyprexa as a dementia treatment, when it had not been approved for such use.
Zyprexa is approved to treat schizophrenia and bipolar disorder. Doctors are allowed to prescribe it for other uses, but Lilly is not allowed to market the drug for any other illnesses because it lacks Food and Drug Administration approval.
The case began in 2004 and was led by the U.S. attorney for the Eastern District of Pennsylvania and the Office of Consumer Litigation of the Department of Justice.
Laurie Magid, U.S. Attorney for the Eastern District of Pennsylvania, said they hoped cases like this put an end to a pharmaceutical practice known as “off-label” marketing.
Laurie – I sure think that is wishful thinking. I read medical records all the time, and the elderly are being prescribed so many anti-psychotics not approved for that use… It is an industry wide issue, and I don’t think one large pay out will make a difference – especially when it is the docs, and not the pharm companies, who ultimately chose what to prescribe.