Sights levelled at dodgy tests

PHARMACEUTICAL giants are under fire as the national medical regulator investigates dodgy Covid tests — with four rapid tests already removed from the market.

The Therapeutic Goods Administration (TGA) has already suspended one sponsor and another is under investigation as part of its post-market analysis of the tests available to Australians.

“Two entries in the ARTG, sponsored by different companies, have been suspended from the ARTG, one of which is now cancelled and the other remains suspended. The suspended entry is still under investigation by the TGA,” a Department of Health spokesman told News Corp.

“Another sponsor has received an infringement notice for failing to provide information and failing to provide adequate customer support.

“Since January 2022, four Rapid Antigen Tests (RATS) have been removed from the

ARTG.”

The watchdog has cracked down on manufacturers who have failed to provide updated medical research on how the tests stack up against emerging Covid strains.

The TGA has also engaged third-party researchers, including the Doherty Institute, to independently verify the claims made by manufacturers in their supporting studies.

“All manufacturers of included RATS included in the ARTG, are required to provide ongoing study data against variants of concern as they emerge and where suppliers (sponsors) are unable to meet their post-market obligations, the TGA may take regulatory action, such as suspending or cancelling the product from the ARTG, or issuing an infringement notice.”

As of July 22, four tests had been removed with more expected as the review makes its way through other provider.

Pharmaceutical giant Hough Pharma was fined more than $100,000 by the

ofmy The experience patients is the RATS ve te st. are not a sensiti With the new strains, they are particularly not sensitive HESPE DRCHARLOTTE

TGA for noncompliance last month.

Royal Australian College of GP President Dr Charlotte Hespe said it was positive the TGA was reviewing all its rapid antigen and PCR tests to ensure they are compliant but also effective on newer strains of the virus.

Dr Hespe said there were concerns the existing tests were not picking up new mutated strains of the virus — BA. 4 and BA. 5 — that are driving in infections in NSW.

“I’ve had lots of my patients telling me they’ve had lots of negative RATS.

“The experience of my patients is the RATS are not a sensitive test. With the new strains, they are particularly not sensitive,” she said.

“We have always tried to message that it doesn’t matter that you have a negative RAT, if you have symptoms you should be out of the community until you don’t have them.”