The health minister says ‘this action will protect Australians from harm and save lives’.
Time is fast running out for Australians to legally access compounded replica versions of type 2 diabetes and weight-loss drugs such as semaglutide and tirzepatide, as the federal government moves to close a loophole that has allowed large-scale production to continue unregulated.
Earlier this week Federal Health Minister Mark Butler announced that from October compounding pharmacists will no longer be legally allowed to compound the drugs.
Semaglutide (Ozempic) is PBS listed in Australia for the treatment of T2D but used off-label for weight loss on an unprecedented scale, while newcomer tirzepatide (Mounjaro) was approved by the TGA last year for patients with T2D, but has so far not been listed on the PBS.
Both drugs remain in shortage throughout Australia, with the TGA’s Medicine Shortage Reports Database showing Ozempic 0.25/0.5mg and 1mg pre-filled injector pens are expected to have limited availability until 31 December this year. Six different strengths of Mounjaro are also listed as “limited availability”, with expected supply to return on 31 August 2024.
National mainstream news outlets including the Herald Sun and The Sydney Morning Herald reported Mr Butler’s announcement.
The move will limit access for an estimated 20,000 Australians who have been buying compounded versions of the drug because they can’t access the branded products due to a global shortage.
Mr Butler revealed the ban would be achieved by removing GLP-1 receptor agonists from an exemption list that allowed pharmacies to compound the medications, from 1 October. Civil and criminal penalties under the Therapeutic Goods Act may apply to anyone who breaches the new regulations, the SMH reported.
“I’m really concerned in the way in which this market has developed that compromises public safety,” he said.
“We recognise there is a valid place for compounding in certain circumstances. This action will not affect compounded medicines other than GLP-1 receptors. While I understand that this action may concern some people, the risk of not acting is far greater.
“You only have to look to the recent reports of individuals impacted by large-scale compounding to realise the dangers posed. This action will protect Australians from harm and save lives.”
TGA Chief Medical Advisor Professor Robyn Langham reportedly backed the plan, and was quoted in the Herald Sun as saying it was “the right action to take”.
The change will take effect from 1 October 2024, to allow patients time to consult with their doctor and find alternative treatments. The HS reported the government said the ban had the support of the RACGP, the Medical Board of Australia, the Pharmacy Board of Australia, Diabetes Australia, the Eating Disorders Alliance of Australia, as well as all state and territory health departments.
“The TGA will work with key medical, pharmacy and consumer stakeholders to support patients and their practitioners to navigate the change, and where appropriate help with guidance in finding alternative and safe medicines,” Professor Langham said.
The SMH said companies compounding the drugs could not be contacted because the government’s decision was not public until late last night, but reported they had previously argued their actions helped make important medicines available to Australians who would otherwise be worse off.
“Without the medication and without the ongoing lifestyle changes that we are trying to do for these patients, the overwhelming data says that those patients will put the weight back on,” it reported Eucalyptus chief executive Tim Doyle had said.
