title: The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine.
abstract: In the past decade, the federal government has frequently investigated and prosecuted pharmaceutical manufacturers for illegal promotion of drugs for indications not approved by the Food and Drug Administration (FDA) ("off-label" uses). State governments can choose to coordinate with the federal investigation, or pursue their own independent state investigations. One of the largest-ever off-label prosecutions relates to the atypical antipsychotic drug olanzapine (Zyprexa). In a series of settlements between 2008 and 2010, Eli Lilly paid $1.4 billion to the federal government and over $290 million to state governments. We examined the effect of these settlements on off-label prescribing of this medication, taking advantage of geographical differences in states' involvement in the investigations and the timing of the settlements. However, we did not find a reduction in off-label prescribing; rather, there were no prescribing changes among states that joined the federal investigation, those that pursued independent state investigations, and states that pursued no investigations at all. Since the settlements of state investigations of off-label prescribing do not appear to significantly impact prescribing rates, policymakers should consider alternate ways of reducing the prevalence of non-evidence-based off-label use to complement their ongoing investigations.
authors.affiliation: Department of Medicine, Stanford University School of Medicine, Stanford, California, United States of America.|Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Bo
authors.identifier: http://orcid.org/0000-0002-0354-4586
authors.initials: B
authors.lastname: Wang
authors.affiliation: Center for Health Policy/Center for Primary Care and Outcomes Research Stanford Medical School & Stanford Law School, Stanford University, Stanford, California, United States of America.
authors.forename: David M
authors.initials: DM
authors.lastname: Studdert
authors.affiliation: Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Ameet
authors.initials: A
authors.lastname: Sarpatwari
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Jessica M
authors.initials: JM
authors.lastname: Franklin
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Joan
authors.initials: J
authors.lastname: Landon
authors.affiliation: Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
mesh_terms: D001569:Benzodiazepines; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D035082:Federal Government; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D000077152:Olanzapine; D013222:State Medicine; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001569:Benzodiazepines; D000077152:Olanzapine