Mundipharma fined for misleading advertising of opioids to health professionals

Mundipharma paid penalties of $302,400 in response to 24 infringement notices issued by the Therapeutic Goods Administration (TGA) within the Department of Health. The infringement notices relate to a claim used in communications with health professionals regarding nine opioid medicines marketed under the name TARGIN.

The notices were issued because the TGA formed the view that Mundipharma had breached the conditions of registration for nine TARGIN medicines, alleging that its advertising to health professionals was misleading, imbalanced and otherwise inaccurate, in breach of the requirements of the Medicines Australia Code of Conduct regarding promotional materials directed to health professionals. As a condition of TGA registration, all sponsors of prescription medicines agree to comply with the Medicines Australia Code of Conduct concerning promotion to health professionals and other matters, irrespective of their membership of that association.

The TGA was concerned that the overall effect of the following statement in Mundipharma’s promotional material did not accurately reflect the referenced guidelines of the Faculty of Pain Medicine, and appeared to positively encourage the prescription of TARGIN medicines for chronic non-cancer pain:

Opioids should be used as part of multimodal pain management plan and in an ongoing trial, as they are associated with potential harms, including unsanctioned use, addiction and overdose.

The TGA considers that opioids should not be represented as a core component of the multi-modal management of chronic non-cancer pain, and the decision to prescribe opioids should be approached with significant caution.

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TGA tackling opioid misuse

Pharmaceutical opioids are now responsible for far more deaths and poisoning hospitalisations in Australia than illegal opioids such as heroin.

Every day in Australia, nearly 150 hospitalisations and 14 emergency department admissions involve opioid harm, and three people die from drug-induced deaths involving opioid use.

The TGA is currently implementing a suite of reforms in the area, including the significant tightening of the ‘indications’ (the appropriate circumstance for use) to restrict the use of opioids in chronic non-cancer pain.

The reforms have been co-designed with the Opioids Regulatory Advisory Group, which includes representation from a range of relevant health professional and consumer groups.

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