GlaxoSmithKline, one of the world’s largest pharmaceutical companies, faces record fines of almost $3 billion following the recent settlement of US civil and criminal disputes. The settlement, reported as comprising a criminal penalty of $956.8 million and almost $2 billion in civil damages, is thought to be the largest ever healthcare fraud settlement in the United States and also includes a five year monitoring period by the US Government to ensure ongoing regulatory compliance by GSK.
The investigation is reported in the Telegraph to have been aided by evidence from four former GSK employees, all of whom are entitled as whistle-blowers under US law to share in up to $250m of the total settlement. Amongst the accusations which surfaced during the long-running litigation were that GSK sold medications for unauthorised uses, bribed doctors to prescribe medicines by holding conferences at luxurious destinations and failed to report safety data about a diabetes drug Avandia, which was banned in the European Union after it was shown to have suspected links to heart disease. It is also reported in the Irish Times that the company promoted the drug Paxil for treating depression in under 18s when it was authorised for adults only. Further, it is alleged to have promoted the drug Wellbutrin for weight loss and attention deficit hyperactivity disorder, even though it was approved for the treatment of depression.
The GSK settlement highlights the role of pharma companies in the protection and promotion of public health and the supervision by national regulatory authorities of post authorisation activity. It is reported by the European Medicines Agency that 5% of EU hospital admissions relate to adverse drug reactions.
EU legislation published in 2010, provides for the introduction of new guidelines for the conduct of pharmacovigilance in the EU. The legislation also introduces the concept of a pharmacovigilance “master file”. This will require the marketing authorisation holder to maintain a pharmacovigilance master file and make it available upon request by the national competent authority. It also provides for a new approach to the use of post authorisation safety and efficacy studies. Adverse drug reaction reporting will be more streamlined under the new legislation and it will provide special provisions for medicines that need additional monitoring.
At the end of July 2012, the Minister for Health signed the regulations giving effect to this EU legislation. Pharma companies operating here are advised to familiarise themselves with the policies set out in the legislation as representing quality standards in pharmacovigilance.
Contributed by Ruth Finnerty and Margaret Muldowney
