Update on Allergan v US off-label case in DC District Court

by Ben Vernia | February 20th, 2010

Many pharmaceutical companies are watching with interest the suit by Allergan against the FDA for an order permanently enjoining the United States from enforcing the Food, Drug and Cosmetic Act against the company for providing information to physicians regarding an off-label use of the company’s blockbuster drug, Botox. On January 25, District Judge John D. Bates entered an order extending the schedule for briefing in the case.

Both sides have now moved for summary judgment, and both are supported by amici curiae. The US’s motion is backed by the advocacy group Public Citizen; Allergan is supported by the National Spasmodic Torticollis Association, the National Spasmodic Dysphonia Association, the Allied Educational Foundation, and the Washington Legal Foundation. (The off-label use at issue in the case is the treatment of spasmodic dysphonia; although Botox is most widely known for cosmetic uses, it is on-label for treating certain conditions associated with cervical dystonia, severe primary axillary hyperhidrosis, and strabismus and blepharospasm associated with dystonia.)

Under the scheduling order, the US has until March 8 to file its opposition to Allergan’s motion and its reply in support of its own motion; Allergan has until March 22 to file a reply brief on its own motion for summary judgment. The Court set April 7 for a hearing on the motions.

The US argues in its brief that Allergan’s complaint is not ripe for review, and that the FDCA is constitutional. Allergan’s complaint and motion argue the FDA’s regulations and enforcement of the Act leave inadequate “breathing room” for constitutionally-protected truthful speech concerning off-label uses.

The company’s complaint can be found here. The briefs currently filed:

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