Healthy Skepticism Library item: 1907

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

O'Reilly J, Dalal A.
Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs
Ann Health Law. 2003 Summer; 12:(2):295-324

Abstract:

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 deserved the public health interest while expanding pharmaceutical company profits.

Keywords:
Consumer Organizations Consumer Product Safety Drug Approval/legislation & jurisprudence* Drug Industry/legislation & jurisprudence* Drug Labeling/legislation & jurisprudence* Humans Investigational New Drug Application/legislation & jurisprudence Liability, Legal Lobbying Marketing/legislation & jurisprudence Prescriptions, Drug/standards* Treatment Outcome United States United States Food and Drug Administration*