Allergan fights FDA over Botox off-label speech

by bvernia | October 5th, 2009

Allergan, Inc., manufacturer of Botox, filed suit in D.C. District Court on October 1, seeking declaratory and injunctive relief against the FDA regarding off-label information it wants to provide physicians regarding the drug, whose active ingredient is botulinum toxin. After reviewing adverse events in patients treated with Botox for upper-limb spasticity, the FDA instructed Allergan to modify its package insert (including a “black box” warning), issue “Dear Dr.” letters, and implement a Risk Evaluation and Mitigation Strategy that would require the company to communicate with physicians concerning the risks of using the drug. Allergan wanted to go further, however, providing what it believes is helpful information concerning Botox’s safety and use in this off-label treatment. Fearing prosecution, the company sought a declaratory judgment that the FDA’s regulations, and the Food Drug and Cosmetic Act’s prohibition, is unconstitutional as applied to truthful, non-misleading speech.

The ramifications of the suit clearly extend well beyond Allergan’s communications regarding Botox, and go to the heart of a key strategy that won the Government a record amount in recoveries under the False Claims Act in the fiscal year just ended.

Paul Clement, Zachary Tripp, and Matthew Lash of D.C.’s King & Spaulding represent Allergan in the suit.

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