Allergan Inc’s $600 million settlement with the Department of Justice—over illegally marketing Botox for unapproved uses such as headache—looks bad for the company’s pending application with the FDA to sell Botox for migraines.

Separately, the settlement also forced Allergan’s management to admit in a press release that they do not have First Amendment free-speech rights to discuss off-label uses of Botox while promoting the drug. (Allergan had sued the FDA on that issue; the settlement requires the company to abandon the suit.)

Until recently, Wall Street believed the FDA probably would allow Allergan to market Botox as a therapy for migraines. However, the whistleblower cases behind the settlement reveal that some Allergan executives do not believe the drug is effective on headaches. One suit alleges that Chandra Coleman, Allergan’s regional scientific services manager, stated in a February 2007 meeting that “the data just isn’t there for headache.”


[Source: BNET]