A federal probe is underway to determine if Abbott Laboratories inappropriately marketed its anti-seizure medication <"http://www.yourlawyer.com/topics/overview/depakote">Depakote for nonauthorized uses, writes the Wall Street Journal. A judge just ordered the lab to provide federal prosecutors with some of its CEOâ€™s emails, the Journal added.
The U.S. Attorney’s Office for the Western District of Virginia is investigating Abbott Labs for “potential federal violations arising out of Abbott’s impermissible off-label marketing of Depakote as a treatment for agitation and aggression in the elderly, and health-care fraud arising out of that allegedly improper use,” wrote U.S. District Judge Samuel Wilson in an opinion dated March 10, quoted the Journal.
Depakote is a U.S. Food and Drug Administration-approved drug that is meant to treat seizures disorders and acute bipolar disorder manic episodes, and to prevent migraine headaches, explained the Journal, which added that Depakote is not approved for the treatment of agitation and aggression in the senior population.
As we have long explained, drug manufacturers are not legally permitted to tout FDA-approved medications for nonapprovedâ€”also known as off-labelâ€”purposes. The practice of off-label marketing is illegal; however, physicians are free to prescribe medications off-label as they see fit.
A number of subpoenas for Abbot documents went unanswered, said the Journal, because the lab said the request was, according to court documents, too burdensome. The subpoenas sought emails sent or received by specific staff from 1996 through 2008, including the recent request for CEO Miles Whiteâ€™s emails, reported the Journal.
The government offered to reduce the request from 13 to three individuals concerning Depakote and potential off-label marketing of Abbott drugs, said the Journal. The lab cited extensive costs, saying it would have to restore back-up tapes containing the emails and fought against the significance of emails concerning off-label marketing of other medications. The U.S. Attorney’s Office in Abingdon, Virginia asked Judge Wilson to order Abbott to comply.
For the most part, Judge Wilson sided with prosecutors, said the subpoenas were not unreasonable and were relevant, and ordered the drug maker to turn over the emails of the CEO and two other key executives at the firm: William Dempsey, a retired executive vice president at the firmâ€™s pharmaceutical products group (Dempsey retired in 2007) and Jeffrey Leiden, former president and chief operating officer of the same group (Leiden stepped down in 2006), reported the Journal.
“The government has indicated that it has evidence that the off-label marketing of other FDA-approved drugs may have followed a similar pattern to the off-label marketing of Depakote,” Judge Wilson wrote. “If this is so, the off-label marketing of these other drugs may raise the same related health-care fraud issues that the marketing of Depakote raises,” Judge Wilson added, quoted the Journal.