The Never-Ending Saga of Off-label Promotion
Jenny McVey, Associate Director, FRA Life Sciences
The concern of misbranded products leading to patient harm and potential fraud is inarguable. The FDA has held a long-standing position on off-label communication; however, in light of recent federal lawsuits that have increased the uncertainty of its enforceability, as well as the growing need for data-driven medicine, the agency has been under pressure more than ever to update their regulatory position. This article will outline industry’s response and the long-awaited guidance from the FDA around off-label communication.