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July 10, 2007 Pharma Times

GSK and Bayer breach Code of Practice

Bayer and GlaxoSmithKline have been named and shamed via adverts in the medical and pharmaceutical press after falling foul of the Association of the British Pharmaceutical Industry’s Code of Practice.

The ABPI’s Prescription Medicines Code of Practice Authority slapped Bayer on the wrist after the company displayed a leaflet already ruled in breach of the Code at a recent scientific meeting.

Earlier this year, the company was ordered to withdraw any promotional material for its impotence booster Levitra (vardenafil) promoting its efficacy just 10 minutes after dosing, but one batch of such leaflets slipped through the net at the British Association of Urological Surgeons conference on June 29.

Bayer voluntarily advised the PMCPA of its mistake, and claimed in its submission that the failure to withdraw the leaflet was an oversight. Even so, the panel ruled that it had breached the following clauses of the Code: clause 2, bringing discredit upon, or reducing confidence in, the pharmaceutical industry; clause 9.1, failing to maintain a high standard; and clause 22, failing to comply with an undertaking.

Appeal upholds GSK complaint
An appeal board also 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. By Selina McKee

more information:
Australia: Levitra marketing criticized: http://www.cbgnetwork.de/1542.html
FDA Orders Levitra Ad Off the Air: http://www.cbgnetwork.de/471.html
Plug pulled on Bayer Levitra campaign: http://www.cbgnetwork.de/1254.html