Mundipharma Pty Ltd (Mundipharma) has 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.
About infringement notices
The TGA can issue an infringement notice where it has reasonable grounds to believe a person or business has contravened the Therapeutic Goods Act 1989 (the Act). The payment of an infringement notice is not an admission of guilt or liability.
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.
Health professional advertising must comply
All sponsors of prescription medicines must comply with the Medicines Australia Code of Conduct when promoting to health professionals, whether or not those sponsors are members of Medicines Australia. The TGA advises sponsors of this requirement when sponsors register their prescription medicines for supply in Australia.
The TGA is reminding sponsors of prescription medicines to ensure that all the claims and information included in their advertising to health professionals are unambiguous. Any ambiguous claims or information may be imbalanced, inaccurate or misleading and therefore potentially breach the Medicines Australia Code of Conduct.
Complaints about advertising for prescription medicines
In the first instance, complaints about the advertising of prescription medicines to health professionals should be lodged with either:
The TGA expects prescription medicine sponsors to engage constructively with the self-regulatory system, irrespective of whether they are members of the industry body concerned.
Any complaints the TGA receives about the advertising of prescription medicines to health professionals will initially be referred to the appropriate industry body for consideration under its specific code.
The advertising of prescription medicines to consumers is prohibited. Complaints about advertising of medicines and other types of therapeutic goods to consumers should be lodged with the TGA.