# The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine

 Title: The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine Author: Wang, Bo; Studdert, David M.; Sarpatwari, Ameet; Franklin, Jessica M.; Landon, Joan; Kesselheim, Aaron S. Note: Order does not necessarily reflect citation order of authors. Citation: Wang, Bo, David M. Studdert, Ameet Sarpatwari, Jessica M. Franklin, Joan Landon, and Aaron S. Kesselheim. 2017. “The effect of federal and state off-label marketing investigations on drug prescribing: The case of olanzapine.” PLoS ONE 12 (4): e0175313. doi:10.1371/journal.pone.0175313. http://dx.doi.org/10.1371/journal.pone.0175313. Full Text & Related Files: 5384770.pdf (719.4Kb; PDF) 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. Published Version: doi:10.1371/journal.pone.0175313 Other Sources: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5384770/pdf/ Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:33030001 Downloads of this work: