05 June 2014
GlaxoSmithKline (GSK) is in yet more trouble with authorities in various different countries as it finds itself on the wrong side of the law.
UK regulator the Serious Fraud Office (SFO) has commenced a criminal investigation looking into the commercial practices of GSK and its subsidiaries.
GSK stated that it 'is committed to operating its business to the highest ethical standards and will continue to cooperate fully with the SFO'.
According to various major media sources, it is understood that the SFO is looking at GSK's conduct across several different countries and jurisdictions, as it has the power to do so under the reach of the UK Bribery Act.
GSK has also settled a lawsuit against 44 US states for a total amount $105 million – the company has been sued for allegations that it unlawfully promoted its asthma drug Advair and its antidepressant drugs Paxil and Wellbrutin.
In addition, the pharmaceutical is forbidden from providing incentive payments to its salespeople, which encourages off-label promotion of drugs and from using paid doctors to promote its products. According to Attorney General Kamala D. Harris, who led the lawsuit, this is the first time in a settlement with a pharmaceutical company, there have been such prohibitions.
The Complaint and Stipulated Judgment, submitted today to the San Diego County Superior Court, alleges that GSK violated state consumer protection laws by misrepresenting the uses and qualities of certain drugs.
Specifically, GSK shall not make promotional claims, not approved or permitted by the FDA that a GSK product is better, more effective, safer, or has less serious side effects or contraindications than has been demonstrated by substantial evidence or substantial clinical experience.
GSK shall not present favourable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions, when presenting information about a clinical study regarding GSK products in any promotional materials.
GSK shall not provide samples of GSK products to those health care professionals who are not expected to prescribe the sampled GSK products for an approved use, but who would be expected to prescribe the sampled product for an off-label use.
Finally, GSK shall also not disseminate information describing any off-label use of a GSK product, unless such information and materials are consistent with applicable FDA regulations and FDA Guidance for Industry.
The British pharmaceutical giant is also currently being investigated by authorities in China, Jordan, Lebanon as well as allegedly Iraq and Poland.