Tough and transparent: TGA set for overhaul

The TGA will work to improve its "engagement with the community", establish a new advisory council and toughen penalties for advertising breaches in a sweeping overhaul aimed at broadening its industry focus to include consumers.

The changes were announced by the administration yesterday after more than 18 months of reviews into the regulatory body and amid widespread concerns that its policing lacks transparency, is too ineffectual and is too restricted in scope.

The reform document, TGA reforms: A blueprint for TGA's future, said the body would now spend the next 12–18 months giving "priority to actively engaging with the community and providing improved information and education materials".

The reforms would "ensure that the regulatory framework... remains able to adapt with flexibility to new scientific developments and emerging community expectations" and "enhance public trust in the safety and quality of therapeutic goods", it said.

The TGA is to work with government and stakeholders to build a "more effective approach to sanctions and penalties" for breaches of advertising rules according to the document.

Any changes should "act as a deterrent" and "bring the current therapeutic goods advertising arrangements into line with other areas of government regulation".

The TGA noted "poor" compliance and "lack of incentives" for suppliers to adhere to its regulations for complementary treatments.

"The flow-on effect of non-compliance... is a reduction in community confidence in the existing regulatory framework and the TGA's oversight of therapeutic goods more generally," advises the report.

The TGA will also give suppliers "increased guidance and cautionary notes... about the potential consequences of providing misleading or unsubstantiated claims". The reforms will also see the body recalling products from the market if they are delisted from the Australian Register of Therapeutic Goods.

However, the report stopped short of answering calls for compulsory labels on all complementary products explaining that the TGA had not tested them for efficacy.

La Trobe University senior lecturer in public health Dr Ken Harvey, an adviser on several TGA reviews, noted that the government accepted many reform recommendations but said he was "particularly concerned" that some much-needed improvements were subjected to "further investigation and consultation".

"What was wanted was a clear statement on the label, on promotional material and above the shelves of complementary medicines that reflects the regulatory reality," he said.

Dr Harvey, a long-standing ALP member, quit his party membership because of his dissatisfaction with the reforms.

In an email sent to his Victorian branch, the department of health and Health Minister Nicola Roxon, he also cited the "failure of democratic reform... at the recent national conference and the failure of the party to be progressive on refugees, climate change, the mining tax, etc".

By Byron Kaye; sourced from Medical Observer.