Australia’s health regulator has fined dozens of companies more than $800,000 for illegally advertising or illegally importing health products to profit from the pandemic.
A company has been fined for trying to sell a ‘bionic air plasma’ machine it says could prevent Covid-19 for elderly patients.
Therapeutic Goods Administration data provided to Guardian Australia shows it has issued 81 infringement notices totaling $847,000 to dozens of companies since the start of the pandemic, including for illegally advertising or importing drugs. masks, medical devices, disinfectants, hand sanitizers, peptide products or thermometers.
This week, the TGA filed a lawsuit against Oxymed Australia after it advertised hyperbaric oxygen therapy chambers as a treatment for Covid-19. The company had previously been fined $63,000 and ordered to remove the ads, but the TGA said it had failed to do so, prompting federal lawsuits.
The Oxymed website has since been taken down, the TGA said.
The TGA too fined a company named Markson Sparks for pushing email advertising about her “bionic air plasma medical device”, which she says could prevent Covid-19.
The ad said the device was safe for seniors, according to the TGA.
“Advertising targeting vulnerable groups, including the elderly, is of particular concern to the TGA during these difficult times,” said Deputy Health Department Secretary John Skerritt.
At the end of August, the TGA published a fine of $12,600 to Medical Sales and Service Pty Ltd, based in Western Australia, for the alleged illegal importation of face masks.
The regulator also has fined based in Melbourne Yarra Valley Cleaning Co Pty Ltd $39,960 for claiming a disinfectant was ‘99.9999% effective’ against viruses including Covid-19.
“The advertisement on the company’s website was allegedly misleading and implied that the disinfectant product had entered the [Australian Register of Therapeutic Goods], when it was not,” the TGA said.
“Advertising for therapeutic products must be truthful, balanced and not misleading. This includes all implied claims.
In its early stages, the Covid-19 pandemic led to a large number of test kit vendors entering the market, particularly those providing point-of-care 15-minute rapid test kits that detect antibodies, as opposed to the genetic tests preferred by most. Governments.
Regulatory review of rapid tests has been “accelerated” due to huge demand for testing supplies.
The Guardian revealed earlier this year that a company attempting to provide rapid tests, Promedical, was run by a convicted rapist with little diagnostic experience and was linked to a failed deal to supply test kits to Porto Rico.
The health department had contracted with Promedical to buy 500,000 rapid test kits that it said it could source from China.
The TGA has since fined Promedical $63,000 for advertising violations.
The regulator has also launched a post-marketing review of the rapid tests, led by the Doherty Institute, to “verify their ability to detect antibodies against Covid-19 and inform their best use”.
This review is still ongoing.
The TGA has also asked rapid test providers to “provide updated additional evidence to support performance claims.”
A supplier of test kits has since been removed from the therapeutics register. Seven others have voluntarily withdrawn from the registry.
Further regulatory action is still being considered, the TGA said, and could include changes to the instructions for use provided with the tests to “ensure that sufficient detail is provided on test performance for samples taken at different times after the onset of symptoms”.
“Other regulatory actions may include suspending or canceling non-compliant or poorly performing tests of the [therapeutic goods register]”said a spokesperson.