Off-Label or out of Bounds? Prescriber and Marketer Liability for Unapproved Uses of FDA-Approved Drugs

Professor O'Reilly's study of recent drug review legislation applies a historical and holistic view of promotion practices for unapproved uses of prescription drugs. He faults Congress for moving public health protections away from a strictly protective mode and toward assistance to drug marketers. He argues that the adverse health consequences of "off-label" promotion of drugs are not well understood, and that the 1997 amendments disserved the public health interest while expanding pharmaceutical company profits.