False Claims Act prosecution did not deter off-label drug use in the case of neurontin

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


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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Amines / therapeutic use*
  • Anticonvulsants / therapeutic use*
  • Cyclohexanecarboxylic Acids / therapeutic use*
  • Drug Industry / legislation & jurisprudence*
  • Gabapentin
  • Humans
  • Liability, Legal
  • Marketing / legislation & jurisprudence*
  • Off-Label Use / legislation & jurisprudence*
  • United States
  • United States Food and Drug Administration
  • gamma-Aminobutyric Acid / therapeutic use*


  • Amines
  • Anticonvulsants
  • Cyclohexanecarboxylic Acids
  • gamma-Aminobutyric Acid
  • Gabapentin