Federal legislation has ‘tied’ the hands of TGA over rapid antigen testing

The Australian man behind COVID-19 home testing kits says federal government legislation has tied the hands of the nation’s drugs regulator in granting approval to rapid antigen testing. The self-test devices, which have shown to be yield an accuracy of 97 per cent, has been approved for use in the United State with the Commonwealth government urged to follow suit. Dr Sean Parsons, the founder of medical manufacturer Ellume, told Sky News Australia the decision to use antigen testing should be a decision for the Therapeutic Goods Administration, not politicians. “For self-testing in Australia for notifiable diseases, there is a special piece of legislation which prohibits them from being reviewed by the Therapeutic Goods Administration,” he said. “Right now, our home test is not able to be reviewed by the Therapeutic Goods Administration or approved for use here and so the TGA’s hands are tied and our hands are tied also. “My perspective on this is that this should be in the hands of regulators, not the legislators, the TGA is a world-class regulatory body, they are more than capable of making a formal decision as to the benefits or risks of this product in Australia better, I venture, than the politicians who are less close to the details there. “So my suggestion, request, indeed, is Mr Hunt, alter that legislation and let the TGA review the benefits of our product and others that do similar things for self-testing, to let the TGA make up their mind as to the benefits and risks for the Australian community.” Via news.com.au — Australia’s leading news site https://www.news.com.au