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 deserved the public health interest while expanding pharmaceutical company profits.
O'Reilly
James
J
Dalal
Amy
A
D003255:Consumer Organizations; D003257:Consumer Product Safety; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D011307:Drug Prescriptions / Q000592:standards*; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence; D016365:Liability, Legal; D008119:Lobbying; D040541:Marketing / Q000331:legislation & jurisprudence; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration