GSK writes off $400M for off-label deal

It's a third strike for drugmakers facing off-label marketing probes: GlaxoSmithKline says it's taking a $400 million charge in the fourth quarter because of an investigation into its sales and marketing practices.

The Colorado U.S. Attorney's Office has been looking into Glaxo's sales practices for nine of its best-selling meds from 1997 to 2004, the company said. According to the Philadelphia Inquirer, GSK previously reported that federal investigators had queried alleged off-label promotion of Wellbutrin SR, an antidepressant often prescribed for bipolar disorder, which is an unapproved use. Sources told the Wall Street Journal that Paxil marketing tactics also are at issue.

Glaxo said the eventual settlement with the feds may vary from the $400 million it's going to charge off now, depending on the U.S. Attorney's findings.

You'll recall that Pfizer announced a $2.3 billion off-label marketing settlement earlier this week, related to its promotion of the Bextra painkiller. And just a few weeks ago, Eli Lilly pledged to pay $1.4 billion to settle mismarketing charges involving its antipsychotic Zyprexa. Will Glaxo's deal be the last for a while, considering the whole jinxes-come-in-threes rule? We'll have to wait and see.

- see GSK's news release
- read the Inquirer story
- check out the WSJ's take