Pharmaceutical giant GlaxoSmithKline today announced it will plead guilty to marketing drugs for unapproved uses and failing to report safety data.
In what is believed to be the largest ever US healthcare fraud settlement, the company will pay out US$3 billion in criminal fines and civil settlements.
The multinational company was charged with violations of the Federal Food, Drug, and Cosmetic Act for marketing Paxil and Wellbutrin for unapproved uses, including the treatment of children and adolescents. The company also conceded charges that it held back data and made unsupported safety claims over its diabetes drug Avandia.
Read more about the charges on Reuters.
In a media statement, GlaxoSmithKline CEO Sir Andrew Witty said. “Today brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made.
“We are deeply committed to doing everything we can to live up to and exceed the expectations of those we work with and serve. Since I became CEO, we have had a clear priority to ingrain a culture of putting patients first, acting transparently, respecting people inside and outside the organisation and displaying integrity in everything we do.
Our colleagues at the UK SMC collected the following expert commentary
Stephen Whitehead, Chief Excutive, ABPI (The Association of the British Pharmaceutical Industry), said:
“The global pharmaceutical industry has fundamentally changed during recent years; where we have made mistakes in the past, we have tried to rectify them – this is not a patient safety concern.
“Our job has always been to develop medicines that will save and improve patients’ lives, and while we have always strived to be innovative, we are now more transparent, more open, and more engaged than we ever have been before. The industry has become an important part of the healthcare environment – we are not just a provider anymore. We recognise our responsibility, and we will continue to do all we can to put the patient first.”
An MHRA (Medicines and Healthcare products Regulatory Authority) spokesperson, said:
“Promoting medicines for unapproved uses is prohibited. We have robust controls in place for the advertising and promotion of medicines and we won’t hesitate to investigate and take action on any potential breaches of medicines legislation.
“We gave clear advice in 2003 that Seroxat (paroxetine) should not be used in children and we have already removed Avandia from use in UK in September 2010 as part of EU-wide action. Anyone using Seroxat or Zyban should not worry but continue to take their medicine. If you have any questions please speak to your healthcare professional.
“We will be following this issue up with GSK as a matter of priority.”
Background
- Paxil – This product contains paroxetine and it is licensed in the UK under the trade name “Seroxat” for the treatment of depression. However, it should be noted that the licence details indicate that paroxetine should not be used for the treatment of children and adolescents.
- Wellbutrin – This product contains bupropion and it is licensed in the UK under the trade name “Zyban” for the treatment of smoking cessation only.
- Avandia – This brand product contains rosiglitazone. This was licensed by the European Medicines Agency (EMA) for the treatment of diabetes. However it was removed from the UK market on 23 September 2010.
Further information about the advertising of medicines can be found here.
Pharmaceutical companies have a legal obligation to report to MHRA any safety data which may affect the risk benefit profile of their medicines.