Time-Series Analysis of New Users of Ziprasidone, 2003–2012.

<p>Patients were enrolled in UnitedHealth insurance. Adults were defined as ≥18 years old and pediatrics defined as <18 years of age. The first time interval ran from the third quarter of 2003 through the second quarter of 2009, when the US Food and Drug Administration’s Advisory Committee convened to discuss use of ziprasidone in the pediatric population. The skip period included the third and fourth quarters of 2009 to cover the aftermath of the FDA’s Psychopharmacologic Drugs Advisory Committee votes and the agency’s period of deliberation. The second time period ran from the first quarter of 2010 through the fourth quarter of 2012.</p

Demographic characteristics of new users of quetiapine, olanzapine, and ziprasidone in the Optum database, 2003–2012.

<p>Demographic characteristics of new users of quetiapine, olanzapine, and ziprasidone in the Optum database, 2003–2012.</p

Time-Series Analysis of New Users of Quetiapine, 2003–2012.

<p>Patients were enrolled in UnitedHealth insurance. Adults were defined as ≥18 years old and pediatrics defined as <18 years of age. The first time interval ran from the third quarter of 2003 through the second quarter of 2009, when the US Food and Drug Administration’s Advisory Committee convened to discuss use of quetiapine in the pediatric population. The skip period included the third and fourth quarters of 2009 to cover the aftermath of the FDA’s Psychopharmacologic Drugs Advisory Committee votes and the agency’s period of deliberation. The second time period ran from the first quarter of 2010 through the fourth quarter of 2012.</p

Statistical analyses of utilization trends of olanzapine, quetiapine, and ziprasidone, using Poisson regression models.

<p>Statistical analyses of utilization trends of olanzapine, quetiapine, and ziprasidone, using Poisson regression models.</p

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

<div><p>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.</p></div

Statistical analyses of utilization trends of olanzapine before and after federal False Claims Act settlement, using Poisson regression models, July 2004 to January 2011.

<p>Statistical analyses of utilization trends of olanzapine before and after federal False Claims Act settlement, using Poisson regression models, July 2004 to January 2011.</p

Statistical analyses of utilization trends of olanzapine before and after state off-investigation settlements, using Poisson regression models.

<p>Statistical analyses of utilization trends of olanzapine before and after state off-investigation settlements, using Poisson regression models.</p

State participation and settlements in illegal off-label marketing investigations of Lilly for olanzapine.

<p>State participation and settlements in illegal off-label marketing investigations of Lilly for olanzapine.</p

Time-series analysis of new adult users of olanzapine for on- and off-label indications before and after state off-label settlements.

<p>The 11 states that pursued and successfully settled independent state-level investigations were included in this analysis: Alaska, West Virginia, Connecticut, Idaho, South Carolina, Utah, New Mexico, Mississippi, Arkansas, Montana, Louisiana (Minnesota and Pennsylvania also pursued state investigations but had not yet reached a settlement at the time of this paper’s final submission). The figure shows aggregated incident utilization data for olanzapine among these 11 states, with the first time interval spanning the two years before each state’s settlement. The month of each state’s settlement served as the breakpoint for our analysis. The second time period spanned the two-year period following the state settlements.</p

Time-series analysis of new adult users of olanzapine for on- and off-label indications before and after federal settlement under the False Claims Act, with states grouped by type of investigation pursued against the manufacturer, July 2004 through January 2011.

<p>The first time interval included the 54 months from July 2004 through December 2008. The US Department of Justice announced the federal False Claims Act settlement with Lilly in January 2009, which served as the breakpoint for our analysis. The second time period spanned the 24 months from February 2009 through January 2011.</p