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ISSUE 1 FEBRUARY
Med Aust code conduct

Medicines Australia Code of Conduct: breaches

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 Four of these were withdrawn and three are unresolved.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

Table 1 Breaches of the Medicines Australia Code of Conduct July 2004 - June 2005
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

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

 

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