Medicines Australia Code of Conduct: breaches
(Aust Prescr 2006;29:16-7)
Medicines Australia has a code of conduct to guide the promotion of prescription drugs by pharmaceutical companies in Australia.1 Complaints are reviewed by the Code of Conduct Committee and the results are published in its annual report. The report for 2005 is available on the Medicines Australia website.2
There were 51 new complaints in 2004-05. Four of these were withdrawn and three are unresolved. As the report includes two complaints held over from the previous year, it contains 46 cases completed by the Code of Conduct Committee.
As usual most of the complaints came from rival companies. It is possible that some complaints are part of a company's strategy as it jostles for market share. In some cases the Code of Conduct Committee had to decide if complainants were abusing the Code.
In 2005 there were 35 complaints in which at least one breach of the Code was found (Table 1), however one case was dismissed on appeal (it involved a $50 000 fine for offering a $500 fee for attending a round table meeting). Details of the complaints can be found in the annual report.2
References
1. Medicines Australia. Code of Conduct. 14th ed. Canberra: Medicines Australia; 2003.
2. 2005 Code of Conduct Annual Report. Canberra: Medicines Australia; 2005. www.medicinesaustralia.com.au
Note: Edition 15 of the Medicines Australia Code of Conduct is available from:
Medicines Australia Level 1, 16 Napier Close DEAKIN ACT 2600
Tel: (02) 6282 6888 Fax: (02) 6282 6299 Website: www.medicinesaustralia.com.au
| Table 1 | | Breaches of the Medicines Australia Code of Conduct July 2004 - June 2005 |
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| Company | Complaint | Sanction imposed by Code of
Conduct Committee | | |
| | | | Drug - brand name | Drug - generic name | | | Abbott | Humira | adalimumab | Withdrawal of promotional material
$5000 fine | | Aspen | Permax | pergolide | Withdrawal of promotional material
Company to undertake education about the
Code of Conduct
$2500 fine | | Aspen | Tazac | nizatidine | Withdrawal of promotional material | | AstraZeneca | Symbicort | budesonide/eformoterol | $100 000 fine for promoting product to advisory boards, reduced on appeal to $25 000 | | Baxter | meningococcal C vaccine | Withdrawal of material for general public
Full-page educational advertisements to be placed in Family Circle, Women's Day, Good Health, and on company's website | | Bayer and GlaxoSmithKline | Levitra | vardenafil | Withdrawal of promotional material from website for general public | | Bayer and GlaxoSmithKline | Levitra | vardenafil | Withdrawal of material for general public
$100 000 fine | | Boehringer Ingelheim | Asasantin | aspirin and dipyridamole | Promotional material not to be used again without qualification | | Bristol-Myers Squibb | Perfalgan | paracetamol | $10 000 fine for promoting product before approval for marketing | | Galderma | Metvix | methyl-5-aminolevulinate | Withdrawal of promotional material | | Galderma | Metvix | methyl-5-aminolevulinate | Withdrawal of promotional material | | Galderma | Metvix | methyl-5-aminolevulinate | Withdrawal of promotional material | | GlaxoSmithKline | Avandia | rosiglitazone | Withdrawal of promotional material
Corrective letter to seminar attendees | | GlaxoSmithKline | Avandia | rosiglitazone | Withdrawal of promotional material
$15 000 fine | | GlaxoSmithKline | Seretide | fluticasone/salmeterol | Withdrawal of promotional material | | Janssen-Cilag | Pariet | rabeprazole | Withdrawal of promotional material | | Janssen-Cilag | Pariet | rabeprazole | Withdrawal of promotional material
Corrective letter
$25 000 fine reduced to $24 000 on appeal | | Merck Sharp & Dohme | Ezetrol | ezetimibe | Withdrawal of promotional material | | Merck Sharp & Dohme | Fosamax | alendronate | Withdrawal of promotional material
Corrective letter | | Novo Nordisk | NovoMix 30 | insulin | Withdrawal of promotional material
$50 000 fine for discussing drug with a
member of the public | | Organon | Puregon Pen | follitropin beta | Withdrawal of promotional material
$5000 fine | | Pfizer | Celebrex | celecoxib | $150 000 fine for media release to the general public, reduced on appeal to $30 000 | | Pfizer | Celebrex | celecoxib | $25 000 fine | | Pfizer | Somac | pantoprazole | Withdrawal of promotional material
$15 000 fine | | Pfizer | Zoloft | sertraline | Withdrawal of promotional material
Corrective letter
$20 000 fine | | Roche | Xenical | orlistat | $20 000 fine for providing unbalanced information
to a television station | | Sanofi-Aventis | Actonel | risedronate | Withdrawal of promotional material
Corrective letter
$50 000 fine | | Sanofi-Aventis | Epilim | valproate | Withdrawal of promotional material
$50 000 fine | | Sanofi-Aventis | Solian | amisulpride | Withdrawal of promotional material
Corrective letter to recipients of guidelines and destruction of remaining copies
$20 000 fine | | Sanofi-Synthelabo | Plavix | clopidogrel | Withdrawal of promotional material
Corrective advertisement | | Serono | Gonal-F Pen | follitropin alfa | Withdrawal of promotional material
Corrective letter
$15 000 fine | | Servier | Diamicron MR | gliclazide | Withdrawal of promotional material
$5000 fine | | Wyeth | Efexor-XR | venlafaxine | Withdrawal of promotional material
$15 000 fine reduced on appeal to $14 000 |
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Content created: February - 2006
