The regulator is continuing its crack down on compounded Ozempic after announcing a consultation on banning the practice last week.
On Friday the TGA, with the assistance of the Victorian Department of Health and the Victorian Pharmacy Authority, raided Como Compounding Pharmacy in Melbourne’s South Yarra, continuing its crackdown on compounded weight loss medication.
On Friday, the TGA announced that it had seized a substantial amount of medication, including compounded semaglutide, the active ingredient in the diabetes turned weight-loss drug Ozempic.
Compounded tirzepatide, the active ingredient in “twincretin” weight-loss drug Mounjaro, was also seized, according to the ABC.
TGA officers also seized peptides and human growth factor, both of which have also been linked to weight loss, although the evidence is mixed and side effects abound.
The TGA said it would allege that these items were “unlawfully manufactured”.
Compounding in large quantities rather than on a per-script basis is illegal without a manufacturer’s licence.
“The TGA held serious concerns around the safety and efficacy of the medication if it were to be dispensed to the public,” the regulator noted in a statement.
Semglutide, the active ingredient in the diabetes turned weight loss wonder drug Ozempic, has been in short supply since 2022, leading some pharmacists to compound the medication to meet the skyrocketing demand.
Semaglutide is also the active ingredient in Novo Nordisk’s TGA-approved obesity drug Wegovy, which has not reached Australia due to the shortages.
Head of the TGA Professor Anthony Lawler warned of serious consequences for any pharmacists compounding unlawfully, which includes mass-producing compounded medication before receiving a prescription.
“It is important that pharmacists understand that they are most likely breaking the law if they are manufacturing or supplying medicines prior to receiving a prescription, except in very limited circumstances,” he said.
According to the TGA, illegal import, manufacture, advertising, supply or export of therapeutic goods may incur financial, civil or criminal proceedings.
The regulator said patients with concerns about dispensed medicines should speak to their doctor and that concerns regarding a clinical practitioner should be raised with AHPRA.
“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,” said Professor Lawler.
The raid coincided with the launch of a “targeted” consultation over whether to prevent compounding of GLP-1 receptor agonists, like semaglutide, amid concerns over safety and compounding en masse.
The regulatory action to disallow compounding of particular medicines has precedent, as similar exclusions were made for medicinal cannabis products in 2021.
Related
On Friday, Consumers Health Forum of Australia (CHF) released a statement which said that it was “comfortable with the call the TGA has made” that the mass distribution of Ozempic by compounding pharmacies was not safe.
CHF said it understood the proposed ban, but the supply issue remained and should be dealt with.
“While public safety must remain the primary consideration for medicines, CHF believes that there are other options available to the government to protect the public while also providing better access to Ozempic,” it said.
The group said the government should work together at all levels to “harmonise standards which audit and review compounding pharmacy services”.
That the federal government should work to improve local supply of Ozempic and should convene a roundtable of stakeholders to workshop supply and use solutions, it said.
“What we are hearing from consumers is that ever since Ozempic has become better known as a rapid weight loss drug for celebrities, suddenly people living with conditions like diabetes, who need the drug for medical purposes, can’t get it,” said CHF CEO Dr Elizabeth Deveny.
“For some it’s almost like their supply has dried up overnight.”
The TGA said that it would continue to work with the Victorian Department of Health and the VPA to “assess the significant number of materials seized, as their investigations continue under relevant laws and regulations”.
As the race for the next even bigger weight-loss blockbuster drug continues, Novo Nordisk has been exploring long-lasting GLP-1 molecules administered like a vaccine that could help “maintain weight loss and have cardiovascular benefits”, according to chief scientific officer Marcus Schindler, STAT reports.
Main image supplied by TGA
