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The federal government will ban compounding pharmacies from producing replicas of popular diabetes and weight loss drug Ozempic (Novo Nordisk) following an investigation that found a compounding racket had marketed and sold illegal replicas of the drug in Australia and the United States.
The ban follows raids by the Therapeutic Goods Administration (TGA) on one residential property in Sydney identified by an ABC’s Four Corners story that uncovered the racket, and reports of patients suffering concerning side effects after injecting unregulated drugs.
Dr Namson Lau is a senior endocrinologist at the Royal Prince Alfred and Liverpool Hospitals, and senior lecturer with UNSW, Sydney,where he specialises in cardio-metabolic obesity and diabetes management.
Dr Lau told InSight+ that he has watched the reports with alarm.
“I am supportive of the federal government’s action,” said Dr Lau.
“My understanding is that compounded agents – which do not have to demonstrate rigorous levels of efficacy or importantly patient safety – were mostly servicing the private, non-pharmaceutical benefits scheme (non-PBS) market for the treatment of overweight and obesity, and also more widely used by telehealth and internet-based medical portals, rather than general practitioners or specialists,” said Dr Lau.
“Professional organisations including the TGA, obesity and diabetes organisations, as well as the medical colleges, have previously made statements discouraging health care professionals from prescribing such agents,” he said.
An ABC Four Corners investigation, published last month, found that patients injecting these medications procured from an illegally operating agent named Total Compounding Pharmaceuticals suffered serious side effects that the patients believe were linked to injecting the drugs. The TGA yesterday released footage from the illegal operation.
Long term shortages of Ozempic fuel replicas
Ozempic was first approved for use in Australia by the TGA in 2019 and its popularity spread during the pandemic. Ozempic is the brand name for semaglutide, a GLP-1 agonist medication that works by activating incretin receptors in the body that ultimately slow the stomach emptying process, increase satiety and reduce hunger. Ozempic has been effective in the treatment of type 2 diabetes but in Australia and internationally, it has been used, off-label, to treat obesity.
Due to its success, demand has greatly overwhelmed supply since 2022. In times of shortage, Australian compounding pharmacists are permitted to reproduce brand name medications, but those drugs are not subject to the same safety checks as the originals.
“The shortages occurred from 2019 to 2020 to the present and affect all of the GLP-1 agonist class available in Australia,” said Dr Lau.
“Ozempic is one of two that are on the PBS in Australia of these weekly incretins,” he said; the latest popular medication Mounjaro is part of the newest line of dual incretins, drugs with the actions of two hormones.
“All of these agents are impacted by the shortage, which occurred because of the uptick in the prescription and impact on global supply chains during the pandemic,” said Dr Lau.
Before the federal ban on compounded replicas, Dr Lau said that the shortages were beginning to lift. “The shortage is improving as production lines improve. Certainly from 2023 to now, the shortage has improved but is still noticed by my patients,” he said.
The TGA says that according to Ozempic’s manufacturer, pharmaceutical company Novo Nordisk, supply throughout 2024 will remain limited.
Dr Lau said that he still has concerns about other compounded agents, and highlighted that there needs to be better regulation in general.
“This regulation does not directly address the issue that for other compounded agents, there remains no need to demonstrate safety and efficacy,” said Dr Lau.
Shortages a major blow for patients with diabetes and obesity
Dr Lau said that his patients have seen significant improvements in many areas of their lives through access to drugs like Ozempic, particularly in the case of his patients with type 2 diabetes.
“I see patients off their drugs for months at a time, so people who’ve previously achieved diabetes remission, you know, that clinically significant 10, 15, 20% off their body weight, a better quality of life, their perception of themselves, better musculoskeletal function, better metabolic health, all leading to better cardiovascular risk. And that was eroded by the fact that they couldn’t access a therapeutic agent [such as Ozempic],” said Dr Lau.
Dr Lau said that he is also a major champion of drugs such as Ozempic for patients with obesity.
“The other thing I wanted to highlight is the pitting of people who have significant obesity, against people with diabetes. As an obesity expert, this drug is quite effective for those who have high range obesity, with other metabolic complications, including sleep apnoea, with this agent there were significant improvements in the quality of life. And [the shortages are] extremely disheartening to them, because they struggle with long term obesity management,” said Dr Lau.
“And I think that one positive take is that I think there’s a greater awareness that obesity is not a failure of willpower, it really is a disease state. And now you have these agents which are uniquely potent, and they can make positive change in people with obesity,” he said.
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The black market will now explode making the problem even worse. As usual , there is no problem that can’t be made worse by government.