Glaxo caught marketing drugs… before approval from regulators

An appeal board upheld a complaint by Sanofi-Aventis over the activities of GlaxoSmithKline’s cervical cancer disease awareness team which, the group claimed, collectively amounted to the promotion of its cervical cancer vaccine Cervarix before it was approved by regulators.

GSK claimed that the team’s role was to educate the relevant health professionals about the burden of cervical cancer and precancerous lesions, the causal role of cancer-causing types of human papillomavirus in cervical cancer, and the importance of the screening programme.

But although an initial ruling sided with GSK, a subsequent appeal ruled GlaxoSmithKline was in breach of: clause 2 and clause 3.1, promoting a medicine prior to the grant of the marketing authorisation which permits its sale or supply.

Advertisements regarding the firms’ inappropriate conduct appeared in the British Medical Journal and The Pharmaceutical Journal last week.

The public naming and shaming of companies breaching the Code has come under criticism in the past for being too weak a punishment. But as the PMCPA’s Niamh MacMahon explained to PharmaTimes UK News, it is not only an effective sanction against the organisations breaking the rules but, importantly, also helps to raise awareness over what constitutes acceptable behaviour.

Well that’s good – Glaxo has been named and shamed. Thank goodness for the ABPI and the drug industry’s self regulation. I’ll sleep safe in my bed tonight…


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