Off-label drug use is facing some headwinds.

FORBES: Patient Safety and 'Off-Label' Drug Use

Case in point: two new reports looking at off-label use of the hemophilia drug NovoSeven and two soon-to-be-released studies comparing the off-label use of Avastin vs.

FORBES: Patient Safety and 'Off-Label' Drug Use

Dr. Yank and her colleagues used a database of hospitalizations to estimate national patterns of off-label use of the drug.

WSJ: Hemophilia Drug's Off-Label Use Is Faulted

But two studies released yesterday in the Annals of Internal Medicine found no evidence that the off-label use of the drug saves lives.

FORBES: Patient Safety and 'Off-Label' Drug Use

Because making any promotional statement regarding the off-label use of a drug constituted, at the very least, a criminal misdemeanor offense, pharmaceutical companies spent millions of dollars annually on compliance and training programs to deter and detect off-label promotion by sales representatives.

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It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so.

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Jean Slutsky, director of the agency's Center for Outcomes and Effectiveness, said the research was undertaken because clinicians have indicated that uncertainly over the risks and benefits of NovoSeven for the off-label uses posed a dilemma on whether or how to use the drug.

WSJ: Hemophilia Drug's Off-Label Use Is Faulted

Off-label use of NovoSeven has previously raised concerns, partly because a drug that promotes formation of clots can increase risk of heart attacks and strokes.

WSJ: Hemophilia Drug's Off-Label Use Is Faulted

Indeed, in the past, Pfizer (nyse: PFE - news - people ), the world's biggest drug company, owed much of the sales volume of its epilepsy medicine Neurontin to off-label use for pain and for disorders ranging from panic to bipolar disorder.

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