Allergan inks $600M off-label settlement

Pharma marketing got another black eye yesterday when the Department of Justice announced a $600 million settlement with Allergan. The drugmaker agreed to plead guilty to a misdemeanor and pay a $375 million fine and $225 million in civil penalties, all for pushing Botox for off-label uses such as headache, pain and cerebral palsy treatment.

It's far from the biggest off-label marketing settlement we've seen; Pfizer owns that crown with its $2.3 billion deal to resolve charges that it mismarketed the now-withdrawn pain killer Bextra and several other drugs. Eli Lilly's Zyprexa settlement, at $1.41 billion, also outranks the Allergan deal. But the Botox settlement beats out AstraZeneca's $520 million resolution to Seroquel mismarketing claims.

But the details of the Allergan investigation set it apart. The company didn't just tout Botox for off-label uses, DOJ says; it actually paid doctors $1,500 to sit through presentations about the wrinkle drug's versatility. The drugmaker deployed a host of sales reps to help physicians with the paperwork required to get Botox covered for unapproved use, investigators say. Indeed, Allergan made off-label sales of Botox "a top corporate priority," DOJ says in a statement.

Meanwhile, federal prosecutors say they're continuing to probe pharma's marketing practices. "This is part of a departmentwide and administrationwide effort to really crack down on health care fraud," assistant AG Tony West tells the New York Times.

- get the DOJ release
- see the NYT piece
- find the article from the Wall Street Journal
- read the Bloomberg story