Under current law, if a drug company wants to promote a new use of its drug, it can do so by submitting an efficacy supplement to the FDA and getting that use onto the label. Or, the company can rely on off-label prescriptions.
While federal law makes it illegal for drug companies to promote drugs for non-approved use, doctors have the right to prescribe what they consider the best treatment for their patients. This is where “off-label” use – that is using a drug approved for one condition to treat another – comes into practice. Today, more than one of seven prescriptions for common drugs are for off-label uses.
A lawyer handling the lawsuits of mentally ill patients is alleging that Eli Lilly carried on a campaign to influence doctors to prescribe its drug for off-label uses. The New York Times broke the story, citing internal documents from Eli Lilly and e-mail messages of its managers showing the company has allegedly been promoting off-label use of antipsychotic drug olanzapine (branded as Zyprexa) to treat dementia.
Currently, olanzapine is only approved by the FDA for the long-term treatment of schizophrenia, maintenance treatment of bipolar disorder, as well as treatment of certain types of acute episodes of bipolar disorder. Even so, Zyprexa is Lilly’s best-selling product with sales of $4.2 billion last year, accounting for 30 percent of its overall revenue. Not a bad return of the effort.
In response to the New York Times story, Lilly argues that numerous studies in the last ten years that the drug has been on the market performed by Lilly, government agencies such as the National Institute of Mental Health, and others, did not show a causal link between Zyprexa and diabetes.
Lilly contends that since Zyprexa was approved by the FDA in 1996, “the labeling provided to physicians identified the potentially clinically-significant weight gain that was observed in more than half of all patients treated long-term with Zyprexa, as well as the diabetes-related adverse events observed in clinical trials.”
Undeer current law, drug makers are barred from pitching doctors directly on unapproved uses of their drugs but, if a doctor or nurse asks a sales representative about it, those questions can be addressed. Companies can also sponsor continuing medical education (CME) sessions where off-label uses can be discussed.
The problem, of course, is that drug companies may push off-label uses of drugs harder than warranted given the evidence. Even if they follow the rules and only hand out journal articles, the information may not tell the whole story since they don’t have to also distribute less favorable studies.
It remains to be seen if the FDA will take action against activities by drug companies that promote off-label uses. If the FDA does take an aggressive stance on off-label use marketing, then it could significantly impact drug sales for companies whose revenues are derived in large part by such off-label use.
