Crackdown on replica weight-loss drugs market

Replica versions of Ozempic will be banned from being made in specialised pharmacies, as Labor moves to crack down on an unregulated drug market.

Copycat versions of the popular weight loss drug Ozempic are being manufactured in compounding pharmacies.

Replica versions of the weight-loss drug Ozempic will be banned from being manufactured in specialised pharmacies, as the federal government moves to crack down on an unregulated drug market spawned by the rise of commercial telehealth.

Health Minister Mark Butler has moved to remove glucagon-like peptide-1 receptor agonists, many of which claim to be replicas of Ozempic or Mounjaro, from legislative exemptions which allow compounded copycat weight-loss pharmaceuticals to be supplied to patients outside of the usual drug regulations.

Compounding drugs – in which a replica of a branded drug is manufactured in a pharmacy specialised in providing custom-made drugs to patients – is usually done at a small scale on an individual basis, such as if a rare drug is out of stock or not supplied in Australia.

However, online telehealth company Eucalyptus has recently begun supplying patients of its ­Juniper weight loss platform a copycat salt semaglutide version of Ozempic, manufactured by its partner compounding pharmacies. Juniper has 20,000 patients on its books.

Unlike products approved by Australia’s Therapeutic Goods Administration, pharmacy-compounded products are not clinically evaluated by the independent regulator for safety, quality or ­efficacy.

The salt semaglutide medication is injected by patients with a needle and syringe. Patients are advised that the medication has not been approved by the TGA.

Pharmacies and the telehealth company are also not obliged to comply with Australia’s strict ­system of post-market drug surveillance, including adverse event reporting.

Eucalyptus says it has no reports from its patients of any adverse events and the drugs are manufactured in a safe compounding pharmacy environment that is subject to strict standards. However, the regulator is alarmed, and the government says there are increasing reports of patients coming to harm from GLP-1 RAs, including the hospitalisation of a patient in Australia due to a serious adverse event.

Internationally, the US Food and Drug Administration has also warned consumers about the safety risks of injecting some compounded products, after an increase in adverse events in the US.

“I’m really concerned in the way in which this market has developed that compromises public safety,” Mr Butler said. “To keep Australians safe, new regulations will remove GLP-1 RA, such as those being misrepresented and sold as replica Ozempic or Mounjaro, from the pharmacy compounding exemptions.

“While I understand that this action may concern some people, the risk of not acting is far greater. The No.1 priority in medicines regulation is safety and effectiveness. This action will protect Australians from harm and save lives.”

The change will take effect from October 1.

The move comes after The Australian reported on rising concerns about the way some players in the rapidly growing commercial telehealth sector were operating in a manner that critics described as continually “trying to find a way around the regulator” in the pursuit of profit.

Much of Australia’s health regulation operates through the Medicare system, and because patients pay privately for medical treatment provided via commercial telehealth, no Medicare regulatory processes are engaged or patient records kept.

Many of the start-ups have been heavily backed by venture capital and were highly valued at the peak of the tech boom, but are likely worth much less since the 2022 market crash and are bleeding cash year-on-year.

Concerns have particularly centred around commercial outfits that not only prescribe medications via their tech platforms but also supply those drugs to patients via commercial pharmacy partners. Such a healthcare model contains in-built perverse incentives and has sparked concerns around inappropriate prescription and overprescription.

Given those concerns, there have been calls for a separate regulator to govern the industry – a proposal that is under active discussion by the Australian Health Practitioner Regulation Agency, the TGA, the Australian Medical Association, and others.

TGA chief medical adviser Professor Robyn Langham said the body would work with doctors, pharmacists and patients to support patients to navigate the regulation change and in some cases provide guidance in finding alternative and safe medicines.