Thursday, December 3, 2009
Off label marketing
Just yesterday I ended my torts class this semester making the prediction that the next "hot" topic in Products Liability will be the issues raised by "off label marketing" of drugs. Now the FDA Law Blog is reporting that Allergan has filed a Complaint and a Motion for Preliminary Injunction in the United States District Court for the District of Columbia to prevent the FDA and the federal government from enforcing regulations on the dissemination of information about off-label uses of FDA-approved prescription drugs. The regulations would prohibit Allergan from sharing information with health care professionals on an off-label use of BOTOX. Go here for the full story. Interestingly, the FDA Law Blog also reports that the Washington Legal Foundation, a conservative think tank which for years dedicated a lot of efforts to oppose the use of IOLTA programs for funding legal services for the poor, has filed an amicus brief in support of Allergan, Inc.’s challenge to the FDA’s regulations. The lawsuit and the amicus brief raise important and very interesting issues. According to the FDA Law Blog story, "the WLF’s brief supplements Allergan’s complaint by expounding on two topics: (1) the importance of off-label uses to the practice of medicine and how overregulation of off-label speech is contrary to public health; and (2) the “three foundational First Amendment principles” necessary to resolve Allergan’s claims. With regard to the first topic, the brief stresses that manufacturers are in the best position to provide important off-label information because they – simply put – have the best access to and understanding of that information and the resources to disseminate it. In addition, the amici curiae argue that this information is critical to HCPs, because, among other reasons, off-label uses of prescription drugs often constitute the standard of care." Stay tuned. I am telling you. This is going to be THE topic in Products Liability in the coming year. I have blogged on this topic before here, here and here.