Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.

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