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Glaxo to pay $90 million to NC, other states for Avandia

Release date: 11/15/2012

Cooper and other AGs allege manufacturer misrepresented drug’s safety risks

Raleigh: Drug maker GlaxoSmithKline will pay $90 million to North Carolina and 37 other states to resolve allegations that it unlawfully promoted diabetes drug Avandia, Attorney General Roy Cooper announced Thursday.
Cooper and the other attorneys general allege that Glaxo engaged in unfair and deceptive practices by misrepresenting the safety of Avandia, especially the cardiovascular risks for those who took the drug.
“Misrepresenting a drug is bad medicine and bad business,” Cooper said. “It’s critical that drug makers give patients and doctors accurate, reliable safety information about their medications.”
Under the settlement announced today, Glaxo agreed to reform how it markets and promotes diabetes drugs. The company may not:
  • make any false, misleading, or deceptive claims about any diabetes drug;
  • make comparative safety claims not supported by substantial evidence or substantial clinical experience;
  • present favorable information previously thought of as valid but rendered invalid by more credible recent information;
  • promote investigational drugs; or
  • misuse statistics or otherwise misrepresent the nature, applicability, or significance of clinical trials.
For eight years, Glaxo must also:
  • post summaries of all observational studies or meta-analyses it conducted or sponsors about the effective, safe, and/or appropriate use of its diabetes drugs;
  • post summaries of clinical trials of diabetes products it sponsors within eight months of the primary completion date;
  • register and post all clinical trials it sponsors as required by federal law; and
  • comply with international requirements for manuscripts submitted to Biomedical Journals.
Under the settlement, North Carolina will receive $2,673,740 for consumer protection purposes. The Attorney General also recovered $400,000 for the State Health Plan.
Cooper’s Medicaid Investigations Division recovered an additional $31.8 million from Glaxo earlier this year in a case that involved allegations that the company made false representations about the safety and efficacy of Avandia and other drugs

Media Contact:  Noelle Talley (919) 716-6413