Thursday, May 6, 2010
What is the "off label marketing" debate all about?
So what is the issue with this "off label marketing" thing?", you ask. Okay, here it is in a nutshell: on the one hand, because the FDA has a duty to protect public safety, it regulates what manufacturers can claim about their products in their marketing campaigns. On the other hand, manufacturers claim the right to freely discuss what they claim are the virtues of their products even if the products have not been approved by the FDA for the purposes the manufacturers want to talk about. As you would expect, consumer and safety advocates side with the FDA's position, while manufacturers, tort reformers and right wing organizations side with the pharmaceutical companies. For more on this go to this short post on Pharmalot; for a comment from the right wing Washington Legal Foundation go here. The WLF has filed briefs challenging the FDA's authority to regulate the manufacturers' statements about their products' non-approved uses. (PS: For readers of the blog who took Professional Responsibility with me in law schoool: you may remember the Washington Legal Foundation as the organization that challenged IOLTA programs to fund legal aid services for the poor.)