My response to the TGA consultation draft document, “Evidence required to support indications for Listed medicines” is available for download here.
The summary says:
“I commend the TGA for preparing this draft document which builds on a previous draft report and consultation on Listed weight loss products. The new draft is much more comprehensive and provides greater clarity for industry and other stakeholders about relevant regulatory requirements. In addition, the difficulty that industry apparently has in interpreting regulatory guidelines should be minimised by the new requirement that a suitably qualified ‘expert’ must ‘sign off’ on a report detailing the evidence supporting the indications and claims made at the time of Listing. I wholeheartedly support the adoption of the document subject to some additional considerations being taken on-board. The latter are detailed in the body of my response”.
The deadline for response to the TGA consultation document is close of business Friday 25 May 2012.
To-date, industry response has been mixed:
Wendy Morrow of the Complementary Healthcare Council said the group had called an “emergency meeting” in response to the proposal, and would strongly oppose it.
“The expert requirements are something industry can’t possibly comply with,” she told Australian Doctor.
“It would be very difficult to find experts. And once you do find them it would be impossible for most companies to be able to afford them — particularly small companies, but also large companies with hundreds of products on the register. It’s going to be hugely expensive for industry.”
However, the Executive Director of ASMI, Dr Deon Schoombie, said, “The release of the draft paper should set the tone for a thorough examination of the way that complementary medicines are positioned in the Australian market.”
“If consumers are to have faith in the rapidly growing complementary medicines industry, there needs to be a high level of confidence, rigour and transparency around the way that complementary medicines are marketed, including the health claims that are made about individual products.”
“ASMI has long argued for appropriate regulation of the sector, with more accurate and timely advice to the public that helps to protect the credibility of those products that are proven and evidence-based.”