TGA approval is sometimes waved around like an imperial flag. Much importance is placed on this ‘imprimatur’. The reality is, TGA approval does not automatically mean that a drug is effective, desirable or even safe! Quite a number of all TGA approved drugs are later recalled or banned due to them later being found to be dangerous or ‘bad’. A significant percentage of TGA approved drugs receive a black box warning. Just because something has TGA approval, there is no guarantee that the drug is safe despite claims by the manufacturer. All TGA approval means, is that a major drug company has paid a lot of money for studies showing efficacy over placebo.
Since January 2016 to the beginning of February 2017 there have been 47 recalls of therapeutic products that have had TGA approval and are now deemed not suitable. The TGA has come in for considerable criticism over the last several years with people such as Senator Nick Xenophon calling for major reform and has described the TGA as a “watchdog in need of a guide dog”. There have been eight (8) enquiries in the last year or so which have made 93 recommendations for reform, from the way it is funded to its secretive system of approving and monitoring medicines and its outdated bureaucracy. Be sceptical of those who claim that just because something has TGA approval, it is somehow safer or better than other products.
By Ron Loftus