Advertising and Promotion Regulatory Affairs Conference

In recent years, the already challenging issues associated with sponsors’ off-label communications have become even more complicated. Following recent court decisions favoring less government restriction of commercial speech in this area, industry and other interested parties anxiously await FDA’s broader policy position, which it committed to comprehensively reviewing in the wake of these First Amendment cases. In the meantime, and also considering the perspectives presented at FDA’s November 2016 public hearing, we will consider where companies might consider altering their traditional policies and where they will want to continue exercising great caution.