GlaxoSmithKline has been sanctioned concerning its future marketing initiatives after agreeing to a $105 million settlement in the USA regarding alleged unlawful promotion of chronic obstructive pulmonary disease and asthma blockbuster Advair and the antidepressants Paxil and Wellbutrin.
The settlement, which covers 44 US states and the District of Columbia, refers to a complaint that the drugs giant “violated state consumer protection laws by misrepresenting the uses and qualities of certain drugs”, namely Advair (salmeterol/fluticasone), Paxil (paroxetine) and Wellbutrin (bupropion).
The deal was announced by California attorney general Kamala Harris who said that “patient care is undermined when pharmaceutical companies promote uses for drugs that have not been approved by the FDA or pay medical professionals to promote certain drugs”. She also noted that apart from the cash, for the first time in a settlement with a major drugmaker, the decision “imposes strong new rules designed to prevent future misrepresentations of GSK products”.
Patient First Programme
Specifically, GSK must continue its Patient First Programme until at least March 2019, which the attorney general’s office says “reduces financial incentives for sales representatives to engage in deceptive marketing”. In addition, the judgment requires “scientifically trained personnel to be ultimately responsible for developing and approving responses to health are provider questions and for these responses to be unbiased and non-promotional”.
GSK did not admit to any wrongdoing and liability, noting that the claims refer to “historic matters that relate to violations of state trade practices laws and are similar to the matters settled with the federal government in 2012”. Then, the company agreed to pay a massive $3 billion for the unlawful promotion of Paxil and Wellbutrin (bupropion) and for failing to report safety data about its diabetes drug Avandia (rosiglitazone).
GSK taking major strides to change
Those cases related to incidents between 2001 and 2007 and GSK has been actively tackling the problem. In a statement sent to PharmaTimes, Mary Anne Rhyne, director of US external communications, noted that it is the first pharmaceutical company “to commit to fundamental reforms to our business model in the US and around the world by stopping payments to doctors to speak about our products [and] stopping payments to doctors to attend medical conferences”.
She added that GSK is also “cutting the tie linking the pay of our sales representatives who call on prescribers in the US to the number of prescriptions issued. We are rolling out this innovative compensation model in the rest of the world”.
Despite these efforts, GSK still remains under a cloud over bribery and corruption charges from China and elsewhere, and last week the UK’s Serious Fraud Office unveiled a probe into the company’s marketing activities.