Mundipharma pays $302,400 in penalties over infringement notices related to marketing claims regarding nine opioid medicines
Mundipharma has paid thousands of dollars in penalties in response to 24 infringement notices issued by the TGA.
The infringement notices relate to a claim used in communications with health professionals regarding nine opioid medicines marketed under the brand name Targin.
The TGA alleged that Mundipharma’s 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.
This related to a statement that appeared in various materials:
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 said it 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.
The TGA considered 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.
In a statement, Mundipharma said it “respectfully disagrees” with the TGA’s assessment of the statement.
“The TGA considered that the ambiguity is caused by the unqualified opening statement that opioids ‘should be used’, combined with the lack of clarity as to whether the harms are intended to qualify the decision to prescribe them,” said the company.
“Mundipharma’s intent with this statement was to proactively and voluntarily urge caution when healthcare professionals chose to prescribe an opioid, and to clarify that this should only be considered in specific circumstances and as part of an overall treatment program if deemed appropriate by healthcare professionals.
“The statement is no longer in use, but we will continue to caution healthcare professionals on best practice in the prescription of opioids,” it said.
“In addition, Mundipharma will continue to strengthen its robust processes to ensure strict compliance with the promotional requirements of the Code and the TGA legislation.”
The company added that it “respects the important role of the TGA in regulating the pharmaceutical industry along with Medicines Australia”.
Mundipharma is the international affiliate of Purdue Pharma, the US company behind Oxycontin which filed for bankruptcy in September last year after it was sued by thousands of municipal and state governments for its role in the overdose crisis.
Purdue settled the opioid litigation to the value of more than $10 billion.
The TGA is currently implementing a suite of reforms in the area of pharmaceutical opioids use, including the significant tightening of the indications to restrict the use of opioids in chronic non-cancer pain.