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  • Title: False Claims Act prosecution did not deter off-label drug use in the case of neurontin.
    Author: Kesselheim AS, Darby D, Studdert DM, Glynn R, Levin R, Avorn J.
    Journal: Health Aff (Millwood); 2011 Dec; 30(12):2318-27. PubMed ID: 22147859.
    Abstract:
    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.
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