Be Careful When Addressing Uses for Unapproved Drugs: Lilly Gets Fined

January 15, 2009 at 10:58 pm Leave a comment

CME provides a safe haven for the discussion of off label uses of drugs. When done correctly, this is a valuable service CME can provide to the medical community. But we have to be careful not to leave that safe haven of reporting the evidence and giving any appearance of marketing. Look at what happened to Lilly. Hopefully no accredited CME provider was entangled in the marketing strategies that cost Eli Lilly a huge fine.

Eli Lilly pleaded guilty to a charge that it illegally marketed the anti-psychotic drug Zyprexa for an unapproved use. They will pay $1.42 billion to settle civil suits and end a criminal investigation.

The plea resolves charges related to Lilly’s marketing of Zyprexa between September 1999 and March 2001 stating that Lilly marketed the drug for the treatment of dementia, including Alzheimer’s-related dementia The drug is not approved for that use. The drug is approved to treat schizophrenia and bipolar disorder.

We know doctors are allowed to prescribe drugs for off label uses but Pharma is not allowed to market a drug for illnesses not approved by the FDA.

We need to continue our due diligence when dealing with content in approved CME activities that address unapproved uses of drugs. I think there are a lot of zeros in a billion.

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Entry filed under: CME, CME Issues, Continuing Medical Education, Physician Continuing Education, Uncategorized.

FDA Guidance on Distribution of Articles Alliance for Continuing Medical Education Member Section Award” Medical Schools

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