Federal prosecutors want to read Miles White's inbox. And a U.S. judge has ordered the Abbott Laboratories CEO to hand over some of his email messages as part of a federal investigation into whether the company promoted its seizure drug Depakote for off-label use, the Wall Street Journal reports.
Apparently, a U.S. Attorney's Office in Virginia is probing Abbott for "potential federal violations arising out of Abbott's impermissible off-label marketing of Depakote" to treat agitation and aggression in elderly patients, the Journal reports. The drug is approved by FDA to treat seizure disorders, bipolar disorder, and to prevent migraine headaches.
Federal prosecutors have been charging hard against off-label marketing, pressing companies to settle claims of improper marketing with record-setting payments. Often attendant on those probes are lawsuits from states and insurers trying to recoup money they paid for off-label use of the marketed drugs.
Abbott has been under investigation for its Depakote marketing for some months now, but details only just now emerged, the WSJ notes, because of some procedural back-and-forth over subpoenas. The company was fighting some requests for documents, saying they were too broad and burdensome. So the feds have agreed to scale back their requests--and the judge weighed in to order Abbott to comply with many of them, including the order for White's emails.
According to the judge's order, the government says it has evidence that Abbott has engaged in off-label marketing of other FDA-approved drugs, using tactics similar to those it used to promote Depakote. "If this is so, the off-label marketing of these other drugs may raise the same related healthcare fraud issues," the judge wrote.
- read the WSJ story