Allergan has agreed to pay $600 million to settle charges that it illegally promoted and sold Botox through 2005 for unapproved uses like treating headaches.
In addition to the monetary fine, Allergan has agreed to a five-year corporate integrity agreement requiring the company to publish information about its payments to doctors.
The agreement also requires Allergan to drop its First Amendment lawsuit against the F.D.A., in which it had claimed free speech protections when giving doctors information about unapproved uses of Botox.
Whether or not DDMAC dodged a bullet on this one is debatable -- but the core issue is clear -- if it's off label you can't promote it. And calling off-label promotion "physician education" is just way too cute.
