US$3B Fine Against GlaxoSmithKline LLC for Off-Label Marketing
GlaxoSmithKline LLC (GSK) was fined $3 billion today after pleading guilty to off-label marketing the drugs Paxil and Wellbutrin, and will be monitored for 5 years to ensure compliance.
This is the largest fine that a drug company has ever paid in the U.S., but will have to be approved by a federal court in Massachusetts.
Acting Assistant Attorney General Stuart F. Deler told the media,
For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business. That is why this administration is committed to using every available tool to defeat health care fraud.
Today’s resolution seeks not only to punish wrongdoing and recover taxpayer dollars, but to ensure GSK’s future compliance with the law.
Off-label marketing refers to when a pharmaceutical company promotes a drug for uses that haven’t been approved by the FDA.
According to prosecutors, GSK illegally promoted the use of Paxil for treating childhood depression, despite the FDA approval only for those over 18. Wellbutrin was only approved to treat major depressive disorder, but was promoted for weight loss, sexual dysfunction, substance addictions and attention deficit hyperactivity disorder. GSK also failed to include post-marketing studies for Avandia about increased risk of congestive heart failure and heart attack which should have been included in safety data.
GSK CEO Sir Andrew Witty stated,
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.
In the US, we have taken action at all levels in the company. We have fundamentally changed our procedures for compliance, marketing and selling. When necessary, we have removed employees who have engaged in misconduct. In the last two years, we have reformed the basis on which we pay our sales representatives and we have enhanced our ability to ‘claw back’ remuneration of our senior management.
We have a vital role to play in bringing innovative medicines to patients and we understand how important it is that our medicines are appropriately promoted to healthcare professionals and that we adhere to the standards rightly expected by the US Government.