Statements like “multi-use” and “dual-purpose” go a long way in the world of advertising. Who doesn’t want more bang for their buck when it comes to product capability?
Consumers are naturally drawn to adaptive, compact solutions – the “all in one” tool that serves a range of needs without compromising on quality.
UK pharma giant, GlaxoSmithKline certainly had this idea in mind when its reps began marketing Advair, Paxil and Wellbutrin for multiple off-label treatments, conditions for which the drugs were never designed and for which they had no FDA approval.
Now Glaxo faces $105 million in settlement fees to more than 40 American states who responded to the sales tactic with a resounding “no,” making it clear that the buck stops here for off-label advertising.
But do fines really work?
Just two years ago in 2012, GSK paid the largest fine in pharma history – $3 billion – for promoting off-label uses for its anti-depressant drugs. In the case of Paxil, the company also sponsored medical journal articles that supported its use in children, even though clinical research has proven the drug can lead to suicidal tendencies in teenagers.
And the depression drug Wellbutrin? GSK has repeatedly marketed it for other applications, including weight-loss and sexual dysfunction.
In response to the fine and to re-build the company’s image, Glaxo CEO Andrew Witty said in 2012, “On behalf of GSK, I want to express our regret and reiterate that we have learned from the mistakes that were made.”
Stronger penalties needed to ensure compliance
Despite Witty’s promise of reform, recent events indicate that the enormous $3 billion payout, and this month’s $105 million fine, amount to little more than slaps on the wrist. Such punishments are doing nothing to dent the Big Pharma pocketbook – or prevent repeat marketing offences.
Over the last two years, in addition to GSK, Abbott Laboratories and Johnson & Johnson have paid marketing fines totalling more than $1 billion. It would seem that in comparison to profits made, these multi-billion dollar penalties are simply absorbed by Pharma giants as an acceptable cost of doing business.
In the interests of pharmaceutical quality control and public health, whistleblowers are now calling for CEO resignations and the enforcement of individual culpability in cases of promotional fraud.
Glaxo refuses to accept responsibility
Although the company agreed to settle claims, this time officials admitted no wrongdoing with regard to off-label marketing tactics. Professionals in the field and students in pharmaceutical courses understand that while doctors are legally permitted to prescribe one drug for a range of conditions, drugmakers are not allowed to suggest alternative uses that have not been approved by regulators.
Ongoing legal breaches in pharma promotion have sparked debate over a range of related issues, such as the demand for public access to trial data, more detailed warning labels, and much tougher penalties for law-breakers.
How do you think pharma marketing violations could be more effectively prosecuted?