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. 2011 Dec;30(12):2318-27.
doi: 10.1377/hlthaff.2011.0370.

False Claims Act Prosecution Did Not Deter Off-Label Drug Use in the Case of Neurontin


False Claims Act Prosecution Did Not Deter Off-Label Drug Use in the Case of Neurontin

Aaron S Kesselheim et al. Health Aff (Millwood). .


Since 2004 the United States has collected approximately $8 billion from fraud enforcement actions against pharmaceutical manufacturers accused under the federal False Claims Act of illegally promoting drugs for off-label uses. Using the case of gabapentin (Neurontin), a drug approved for epilepsy but prescribed for a variety of conditions, we sought to determine whether the enforcement action also influenced off-label prescribing rates. We conducted a segmented time-series analysis using key legal milestones: the initiation of a sealed investigation, public announcement of the investigation, and settlement of the case. Off-label use grew steadily until settlement, when gabapentin prescriptions declined for both off-label and on-label indications. Because enforcement actions targeting illegal off-label promotion might not have a substantial deterrent effect on prescription rates until after settlement, they should be combined with other efforts to combat off-label promotion. These could include additional resources for enforcement and a steep increase in penalties because settlements to this point have been dwarfed by the financial gains to pharmaceutical companies from engaging in improper off-label marketing.

Comment in

  • Confounding factors in off-label drug use.
    Greenberg PE, Pike C, Sisitsky T. Greenberg PE, et al. Health Aff (Millwood). 2012 Feb;31(2):460; author reply 460. doi: 10.1377/hlthaff.2011.1394. Health Aff (Millwood). 2012. PMID: 22323178 No abstract available.

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