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Justice Department's Botox Probe Costing Allergan $100M -- And There's No End in Sight

Allergan (AGN) is under siege from prosecutors, according to its annual report, and may burn nearly $100 million in legal fees defending itself against the government. The company previously reported that it had spent $7 million responding to a subpoena regarding the sales and marketing of Botox earlier this year, but that's not the only investigation going on at the company right now. Allergan said:

During 2009 and 2008, the Company incurred approximately $32.2 million and $25.7 million, respectively, of costs associated with the DOJ's inquiry related to Botox®
... Costs associated with responding to the DOJ investigation during fiscal year 2010 are expected to total approximately $30.0 million to $40.0 million
That's $98 million spent on lawyers to assist the Department of Justice in a case where no charges have yet been filed. In addition, Allergan is responding to two more new subpoenas:
  • January 2010: Allergan received a subpoena from the attorney general of Delaware on dry-eye drug Restasis and Acular LS, an eye-drops brand.
  • September 2009: Allergan received an "Investigative Demand" from the DOJ in Oregon regarding Aczone, Allergan's acne drug.
The Botox case revolves around allegations of "off-label" promotion of the drug for the unapproved purpose of migraine treatment. Allergan later filed a suit against the FDA asserting a First Amendment right to promote Botox for migraine. (Allergan denies the events are linked but it's hard to see how they're not, especially as Allergan has applied for approval to market Botox for migraine.)

The company said it believed the Aczone and eye-drug investigations will likely not be material. Botox is a different story, however: "Management is currently unable to predict the ultimate outcome or determine whether a liability has been incurred or make an estimate of the reasonably possible liability that could result," the company said.

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