GlaxoSmithKline endocrine/metabolic, neurology news
GlaxoSmithKline finalized a $3 billion settlement with the U.S. government and will plead guilty to misdemeanor charges related to the marketing of antidepressants Paxil paroxetine and Wellbutrin bupropion and failure to report safety data to FDA for diabetes drug Avandia rosiglitazone. According to the Department of Justice, the settlement includes about $2 billion to resolve civil liabilities for promoting off-label uses and paying kickbacks to physicians; making false and misleading statements about Avandia's safety; and reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program. Additionally, GSK entered into a five-year Corporate Integrity Agreement (CIA) with HHS's Office of Inspector General, which includes provisions that require GSK to change sale force compensation that is based on sales goals for territories.
The guilty plea and the sentence are not final until accepted by the U.S. District Court for the District of Massachusetts. Last year, GSK said it had agreed in principle to the $3 billion settlement (see BioCentury, Nov. 7, 2011). ...