title: False Claims Act prosecution did not deter off-label drug use in the case of neurontin.
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.
authors.affiliation: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA. akesselheim@partners.org
authors.forename: Aaron S
authors.initials: AS
authors.lastname: Kesselheim
authors.forename: Devan
authors.initials: D
authors.lastname: Darby
authors.forename: David M
authors.initials: DM
authors.lastname: Studdert
authors.forename: Robert
authors.initials: R
authors.lastname: Glynn
authors.forename: Raisa
authors.initials: R
authors.lastname: Levin
authors.forename: Jerry
authors.initials: J
authors.lastname: Avorn
mesh_terms: D000588:Amines / Q000627:therapeutic use*; D000927:Anticonvulsants / Q000627:therapeutic use*; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D000077206:Gabapentin; D006801:Humans; D016365:Liability, Legal; D040541:Marketing / Q000331:legislation & jurisprudence*; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*
chemical_list: D000588:Amines; D000927:Anticonvulsants; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin