To start with, it is very rare that a pharmaceutical company goes to court against FDA for any reason. It is even rarer for companies to call attention to themselves when they do. It is rarer still for the company’s CEO to host an analysts call to discuss the litigation—especially when there is no underlying news driving the suit.
But Allergan Inc. took those unusual steps at the start of October when the company filed suit seeking pre-emptive action to block FDA from enforcing its prohibition on off-label promotion in the context of a new post-marketing Risk Evaluation & Mitigation Strategy imposed on the botulinum toxin brand Botox. ...
This article preview is reprinted from The RPM Report, October 2009. Not a subscriber?
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