Off-Label Communications: The Prodigal Returns

Jeffery Chasnow and Geoffrey Levitt

INTRODUCTION

Recent changes in law and policies relating to “off-label” product communications by manufacturers (OLPC) bring to mind the biblical parable of the Prodigal Son.1 In the parable, the Prodigal Son behaves very badly but—to the dismay of his dutiful brother—is welcomed back by their forgiving father. Like the Prodigal, OLPC has a checkered history; for many years, OLPC was banished and distrusted. With a boost from the First Amendment, however, OLPC is rejoining the communities of medical practice and discussion. Much as the wise father welcomed his Prodigal Son home, FDA similarly needs to reconsider its traditions and biases against OLPC.