Last week, when we unveiled our Top 10 Pharma Settlements report, we promised to update it as new deals hit the news. We didn't realize we'd need to fulfill that promise so quickly. Today, GlaxoSmithKline officially announced its $3 billion settlement, which puts it squarely on top of that list.
Glaxo's deal covers off-label marketing and kickbacks claims, plus allegations that it held back safety data on Avandia and charged inflated prices to Medicaid programs. It includes a $1 billion criminal fine and $2 billion in civil payments. The civil settlement wraps up four whistleblower lawsuits, so presumably, some former Glaxo employees will soon receive government checks for their share.
The settlement follows years of investigations, and it covers misconduct reaching all the way back to 1994. Besides the fines and penalties, Glaxo will plead guilty to three criminal counts, two for selling misbranded drugs--a typical charge in an off-label settlement--and one for failing to report safety data to FDA.
It's a settlement historic in size and scope, the Justice Department points out in a statement detailing the criminal and civil claims. It also closes a chapter in GSK history. At least that's how CEO Andrew Witty sees it. Just as Justice listed the allegations against his company in its press release, in Glaxo's, Witty lists a series of changes aimed at preventing misconduct. Whether they'll work remains to be seen, of course. Compliance is a slippery goal.
Now that Glaxo has announced its deal, two more off-label settlements are expected this year. Johnson & Johnson's is set to wrap up any day now, or so sources have been saying. And Amgen's is expected to follow. As we pledged before, we'll keep this list updated. Click here to read the full report >> --Tracy Staton (email | Twitter)