MUNDIPHARMA DISAGREES WITH TGA ASSESSMENT

December 20, 2019 - 2 minutes read

REACTIVE STATEMENT

After an extensive review of various Targin materials developed by Mundipharma Australia for Healthcare Professionals, the Therapeutic Goods Administration (TGA) issued several infringement notices as it considered that a sole statement which was included in all of the materials was in breach of the Medicines Australia Code of Conduct (the Code).

The TGA considered that the statement, included below, is ambiguous as it is unclear whether it positively promotes the use of opioids as an important part of multimodal pain management, or whether it expresses caution due to the potential risks, or both.

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

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.

Mundipharma respectfully disagrees with the TGA’s assessment of the statement but respects the important role of the TGA in regulating the pharmaceutical industry along with Medicines Australia.

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.

Based upon this single statement the TGA issued several infringement notices as the statement appeared in various different materials, and was applied to all strengths of Targin.

The statement is no longer in use, but we will continue to caution Healthcare Professionals on best practice in the prescription of opioids.  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.

Mundipharma has comprehensive and robust systems and processes in place to ensure that all of our materials and claims are supported by strong medical evidence and scientific guidelines and are in full compliance with all applicable laws and industry standards.