Government bans copies of Ozempic weight loss drug after footage of dirty lab raid released

The federal government will ban all pharmacists from making copycat versions of diabetes drugs like Ozempic and Mounjaro, widely used off-label for weight loss, amid public safety concerns.

It comes after a Four Corners investigation revealed an Australian registered pharmacist was running an international pharmaceutical racket that manufactured Ozempic copies and illegally exported it to the United States.

The ABC also found that patients who injected drugs from Total Compounding Pharmaceuticals (TCP) suffered serious side effects including nerve damage, rashes, vomiting blood and bleeding gums, symptoms they believe are linked to the compounded drugs.

Currently, an exemption allows Australian pharmacists to individually reproduce brand-name drugs in times of shortage, meaning that copycat drugs are legal, but they are not subject to the same strict safety checks as brand-name pharmaceuticals.

Federal Health Minister Mark Butler announced today that the loophole will be closed from October, when the active ingredients in drugs such as Ozempic will be removed from the exemptions.

“These exemptions have never allowed for the kind of large-scale production that we’re seeing in this market with products claiming to be Ozempic or Mounjaro. And frankly, they pose a very significant security risk,” he said.

In Australia, it is estimated that at least 20,000 Australians have used weight loss medications, but the true number may be much higher.

ABC reported late last year at least five known compounding pharmacies were making drugs for patients and several telehealth companies were prescribing them.

In February, the TGA raided a Victorian pharmacy, Como Compounding, and seized bottles of compounded semaglutide, the active ingredient in Ozempic, which the agency claimed was illegally manufactured.

Ozempic and Mounjaro are popular “off-label” choices for doctors treating patients who want to lose weight, but the drugs are only TGA-approved for the treatment of type 2 diabetes.

Mr Butler said he was concerned that tens of thousands of patients on compounded versions of the drugs were not aware of potential safety risks, which have also been highlighted by the FDA in the United States.

“There is no oversight of the production of these products, the conditions under which they are produced. There is no oversight of the ingredients that go into these products and there is no formal system for reporting any adverse events,” he said.

“The clearest possible advice from our safety regulators to me was that we need to shut down this market. It poses too great a risk to public safety.”

Pharmacist using Nutribullet in a dirty lab

The announcement comes after footage obtained by the ABC reveals the filthy conditions in which illegal Sydney pharmacy Total Compounding Pharmaceuticals (TCP) allegedly manufactured the Ozempic knockoff.

A video filmed by TGA investigators executing a search warrant shows a commercial premises in western Sydney stockpiled with chemicals and filled with re-used kitchen mixers and blenders.

There are dirty hot plates and equipment used for mixing chemicals on the floor.

The TGA published the vision for the ABC to warn the public about the dangers posed by compounded medicines allegedly made at the facility, which it says are substandard and could pose a serious risk to human health.

The TGA will claim the footage demonstrates the “similar commercial scale” of the operation and that “extremely poor quality standards of compounded weight loss products occurred”.

TCP was able to operate under the authorities’ radar for years, promoting compounded weight loss drugs directly to doctors in Australia and the United States, who then recommended the pharmacy to patients.

The chair of the Medical Board of Australia, Professor Anne Tonkin, a former clinical pharmacologist, said the conditions seen in the video were worrying for doctors and patients.

“A non-sterile facility that produces a material that is designed to be injected is very dangerous indeed,” she said.

“This seems very far from the standards one would expect from a manufacturing plant.

“I think it’s disappointing to think that a registered pharmacist would understand that it was an ethical thing to do and it’s inconsistent with their pharmacy registration.”

The Sydney pharmacist who runs the TCP, Emad Azzer, has now had his registration suspended entirely. His home was raided shortly before the Four Corners program aired last month.

Dr Tonkin said more broadly, the TGA had informed the Medial Board that it had concerns that some compounding pharmacies were using imported raw ingredients that had not been properly safety tested.

“It is very important when mixing something that the raw material is what you think it is and that it is free of any kind of impurities,” said Dr Tonkin.

Doctors’ groups welcome Ozempic copy ban

The proposal to ban compounding of weight loss medications was supported by the Pharmacy Board of Australia, Diabetes Australia, the Medical Board of Australia and the RACGP during the consultation period.

But it was fiercely opposed by several pharmacy groups as well as telehealth companies such as Eucalyptus, which has about 20,000 patients, including many on the compound semaglutide.

Eucalyptus clinical director Dr Matthew Vickers previously said any suggestion of a complete ban on the compound semaglutide would be “disproportionate” given the global shortage and would deny “thousands of Australians access to life-changing medicines them for good”.

Dr Vickers added that Eucalyptus only uses “reputable compounding pharmacies” and had not seen any “unexpected” serious adverse safety events from compounded semaglutide.

He says the company has also commissioned extensive independent testing at three universities, going above and beyond current compounding requirements.

However, RACGP president Dr Nicole Higgins believes the current lack of legal checks and balances for compounding pharmacies more widely means a total ban is necessary for public safety.

“This has been a big business on a large scale that is happening outside of our regulations and our rules,” she said.

“It happened in unsanitary places, which means we could get contamination. It means we don’t know what’s necessarily in that medication.

“People have had numbness and tingling in their hands and feet or localized reactions from the injections.”

The announcement of a ban is set to frustrate patients who have relied on a steady supply of compounded drugs after struggling to access brand-name drugs.

Dr Higgins admitted that removing the compound as an option for patients from October would cause concern for many prescribed weight loss drugs.

“We already have a shortage of this medication for the people it was originally designed for, which is ours [people with] type 2 diabetes. I expect those shortages could get worse and that will cause anxiety for those who have been using Ozempic off-label,” she said.

“We understand this will cause concern for people. Go back, touch base with your GP and your healthcare team who can help you on your weight loss journey,” she said.

The latest TGA shortage update says supply of Ozempic throughout 2024 will be limited due to increased demand in weight loss use. Diabetes drug Mounjaro is also expected to be in short supply until at least September.

Federal Health Minister Mark Butler said the government was working with pharmaceutical companies to mitigate the effects of the ban.

“I’m concerned that this will have little impact on that market, which is why I’ve put in place this four-month transition period,” he said.

“It’s an important part of their treatment and I want to make sure those patients are taken care of first and foremost.”

Loading…