Off-Label Communications: A Guide to Sales & Marketing Compliance
3. Off-Label Discussion Before and During Clinical Trials
By Mark E. DuVal and Bradley Merrill Thompson
By this point, the book has provided excellent background on the legal underpinnings for off-label promotion and dissemination. The task now is to discuss off-label uses of products in the context of clinical trials. This helps the reader understand how clinical trials intersect with off-label promotion and other forms of communication. Thus the chapter begins with a conceptual layout of how one might view this world. What does a manufacturer confront when it markets a product that has utility well beyond its approved label? Remember, to discuss “off-label” uses implies that the product is already approved, has a label and there is potential for off-label uses of that product. Also, remember that off-label does not mean that the off-label use is inappropriate, nor is it necessarily dangerous. Rather, it means the product is deemed safe enough to be on the market, but it has not been studied for that particular unapproved use.