Replica Ozempic and Mounjaro to be banned

Chelsea Heaney

22/05/2024 4:37:18 PM

The Government has removed a loophole allowing the mass production of the compounded drugs amid growing patient safety concerns.

Compounding pharmacy lab
The footage, supplied by the TGA, shows a lab in disarray. (Image: TGA)

Compounding pharmacies will be banned from producing replicas of Ozempic and Mounjaro from 1 October, as demand for the social-media-famous-drugs continues to reach new heights.
The Federal Government made the announcement on Wednesday, revealing at least 20,000 Australian patients are currently injecting the compounded replica products, with the majority using it for weight loss.
The Commonwealth said these compounded products’ large-scale manufacture poses a ‘clear risk to human health’.
It comes on the same day as the Therapeutic Goods Administration (TGA) released bodycam footage from a raid of an unsanitary lab, cluttered with kitchen equipment, allegedly used to manufacture semaglutide.
RACGP President Dr Nicole Higgins said the conditions captured in the video were appalling, saying these types of labs are being ‘driven by big business that put profits before patients’.
‘It is, quite frankly, disgusting,’ she told newsGP.
The Federal Government says the concern stems from compounded glucagon-like peptide-1 receptor agonists (GLP-1RA) products being not identical to the TGA-approved products semaglutide (sold as Ozempic) or tirazapetide (sold as Mounjaro).
The new regulations will remove these from the pharmacy compounding exemption, a move which Health and Aged Care Minister Mark Butler said would save lives.
‘While I understand that this action may concern some people, the risk of not acting is far greater,’ he said.
Minister Butler said the four-month period until the regulatory change comes into effect is not meant to give the industry a transition period, but instead to give patients a transition period.
The growth in demand for semaglutide and tirazapetide has led to severe shortages of the medications, with the TGA warning GPs not to initiate new patients unless there are no suitable alternatives.
These shortages are expected to last until at least the end of the year.
Dr Higgins said GPs are ‘often under significant pressure from patients’ to prescribe these medications but should attempt to use consultations as an opportunity to talk about other options.
‘The ethics around using heavy marketing for people that are vulnerable needs to be questioned,’ she said.
‘Although I appreciate that for some this medication makes a significant difference, it’s important we recognise the way these medications are being produced is not safe.’
Minister Butler said he has been working with stakeholders, including the RACGP, who are all in support of the ban ‘with the exception of the businesses that are in the market’.
He said doctors have been told for ‘for some time now’ to prioritise prescription of these medicine to those with diabetes.
‘Diverting supply of these drugs, when they’re in short supply, for alternative purposes is something we’re strongly trying to discourage among doctors,’ he told the ABC.
The TGA is now working with the companies producing Ozempic and Mounjara in attempt to determine when the global shortage will ease.
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Dr John Maxwell Hollingsworth   23/05/2024 12:14:11 PM

Have been a type 2 diabetic for 15 years and was put on Ozempic 3 years ago with good effect. Since December 2023 I have been unable to get Ozempic even though I am a diabetic type2. With the drug getting $800 US overseas and $130 in Australia where do you think most is sold . I have change treatment and will probably never go back on it.