The Neurontin Controversy: The Saga of Off-Label Drug Regulation Continues
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CitationThe Neurontin Controversy: The Saga of Off-Label Drug Regulation Continues (2004 Third Year Paper)
AbstractThe regulation off-label drugs is a complicated and controversial area of the law. Regulators must protect patientsâ€™ safety without interfering with physiciansâ€™ practice of medicine or manufacturersâ€™ First Amendment rights. The recent Neurontin decisions, which apply the doctrine of false claims to prescription drug regulation, only adds additional complexity. This paper explores the federal governmentâ€™s attempts to regulate the promotion of off-label drugs. It discussed the advantages and disadvantages of off-label marketing, the current regulatory environment, and the implications of the Neurontin lawsuit.
Citable link to this pagehttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8963868
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