Category Archives: Off Label

Shifting Regulatory Landscape for Off-Label Promotion Continues

On Wednesday, July 12, 2017, the Health Subcommittee of the Energy and Commerce Committee held a hearing to discuss proposed legislation that would impact the regulation of off-label use and promotion for drug products. There were representatives from all facets of the industry discussing the potential impact of decreasing regulation of off-label use of drugs and how it could affect patients, the public, manufacturers, and the economy. The FDA last solicited public comment on the issue of off-label use over six years ago, and the…

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Green Light for Aetna in RICO Suit

On April 3, 2013, the First Circuit held that Aetna, Inc. can sue Pfizer, Inc. for its off-label marketing of Neurontin®.  Neurontin® was approved for the treatment of epilepsy, but was allegedly marketed for the treatment of bipolar disorder and neuropathic pain in the mid 1990’s.  Aetna brought RICO and Pennsylvania Insurance Fraud Statute claims based on the off-label marketing. In reinstating the case, the Court found that the plaintiffs were not required to prove that the doctor’s off-label prescriptions were caused by the off-label…

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