Australia’s drug and medical device watchdog, the Therapeutic Goods Administration, needs a complete overhaul to distance it from the health industry and allow consumers to sue it for negligence, say academics and consumer advocates after the regulator quietly announced moves to classify all pelvic mesh devices high risk after years of controversy.
“The current regulatory framework is a complete bypass of the interests of consumers. They don’t have a stake at the table,” said University of Canberra academic Wendy Bonython, after the TGA said the new classification would mean “higher evidentiary requirements” before new devices are approved for use in Australia, and for existing approved devices.
The move comes more than a decade after many pelvic mesh devices were cleared for use by the TGA with little or no independent evidence of safety and efficacy.
The announcement on the TGA’s website on October 26 also follows evidence at a Senate inquiry about the devastating and permanent consequences of mesh surgery for thousands of Australian women, and a class action by women against mesh manufacturer Johnson & Johnson.
Dr Bonython and University of Canberra associate professor Bruce Arnold told the Senate inquiry the TGA’s “industry-funded model of regulation” raises questions about the regulator’s independence in the wake of a string of device scandals, including pelvic mesh, joint prostheses, breast and contraceptive implants, cardiac stents and pacemakers.
The failures indicate “systemic weaknesses in the prevention of and response to foreseeable harms”, with the “enormous” cost borne by individuals and the broader community, they said.
“Trying to run a regulator on a shoestring, particularly a medical device regulator, is a bit of a false economy because if we’re not investing in the regulator, chances are we’re going to be subsidising its failures through things like the National Disability Insurance Scheme or Medicare, or lack of productivity,” Dr Bonython said.