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Authorities raid pharmacy, plan off-brand Ozempic ban
Drug administration investigators have raided one of the country’s largest compounding pharmacies, seizing off-brand Ozempic and other allegedly unlawfully made medication.
It follows the Therapeutic Goods Administration’s announcement on Thursday that it plans to ban the sale of pharmacy-made versions of Ozempic, which are currently legal.
Vials of semaglutide seized by the Therapeutic Goods Administration on Thursday.
TGA investigators executed a search warrant at Como Compounding Pharmacy in the inner Melbourne suburb of South Yarra on Thursday, where they took dozens of vials of the raw ingredient in Ozempic, called semaglutide. The investigators also seized peptides and human growth hormones.
“The TGA held serious concerns around the safety and efficacy of the medication if it were to be dispensed to the public,” it said in a statement.
The head of the TGA, Anthony Lawler, said pharmacies were likely breaking the law if they compounded medicine before receiving a prescription from the patient’s doctor.
“Consumers need to understand that the safety of compounded medicines are not assessed by the TGA, and they are not subject to the same controls over the quality or efficacy of the goods when compared with medicines approved for supply in Australia,” Professor Lawler said.
Ozempic, originally created as a diabetes medication, has been used as a breakthrough weight loss drug. But it is only manufactured by one company, the Danish drug giant Novo Nordisk, and has been in short supply in Australia for more than a year.
That has prompted many consumers to buy compounded versions made by pharmacists, who are allowed to create medicine on a one-off basis when their patient’s regular medication is unavailable.
That exception has been used on a large scale by companies including Eucalyptus, the telehealth start-up behind the Pilot and Juniper brands, to offer patients compounded semaglutide. It has never sourced that medication from Como Compounding Pharmacy, instead using two other pharmacies that have had their medication assessed by outside experts.
Strict standards urged
Eucalyptus clinical director Matt Vickers said it had chosen its partner pharmacies because of their track records in safety and quality, and it had never had a “serious adverse event” reported. Dr Vickers said Eucalyptus supported strict standards for compounding but opposed a ban, adding it would hurt people who needed the medication including people with diabetes.
“A complete ban on compounded semaglutide would be disproportionate while global shortages persist and would deny thousands of Australians access to medication that is changing their lives for the better,” Dr Vickers said.
The TGA proposed the ban on the basis that the ingredients used were often unknown, suspicions some pharmacists were breaching rules on compounding only with a script, and the absence of safety testing by the regulator. It is currently seeking feedback on the proposal and will make a decision, which will have to be approved by the federal health minister, by June.
Novo Nordisk, which has become a $687 billion company in large part because of its weight loss drugs, has urged regulators to stop pharmacies making versions of Ozempic on safety grounds.
A Como Compounding Pharmacy staff member declined to comment on Friday. An email requesting comment was not returned.
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