Late last week Allergan initiated a novel approach to avoiding FDA regulatory action on off label promotions: a lawsuit, complete with a request for an injunction against FDA. Specifically, Allergan alleges that because FDA prohibits promotion of off label uses for Botox, Allergan’s First Amendment right of free speech is being violated. Allergan would like the court to grant an injunction to prevent FDA from taking any action during the course of the lawsuit. Allergen claims that it is being wrongfully prevented from “…sharing relevant and truthful information with physicians regarding the risks and benefits and techniques for off label uses…” Allergan complains that FDA “allows” doctors to use products off label, while preventing drug companies from providing information, but appears to neglect to mention that FDA lacks the authority to control physician’s actions in this regard.
Needless to say, success for Allergan would pretty much put regulation of drug promotions out of business. Experts generally think that a win for Allergan is unlikely. Then why do it? For one, Allergan is currently under a requirement to provide a REMS for Botox, including warning about off-label uses. Second, the New York Times reported Saturday 10/3/2009 that federal agents in Georgia were investigating promotional practices regarding off-label use of Botox for headaches. Perhaps Allergan is acting on the old saw, “The best defense is a good offense”.
This posting is provided by Bill Stoltman, J.D., Camargo’s Senior Director of Quality Assurance and Compliance firstname.lastname@example.org.