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Topic: TGA
A call for clarity in policy around drugs known as “biosimilars”

A call for clarity in policy around drugs known as “biosimilars”

The Pharmaceutical Benefits Advisory Committee and the Therapeutic Goods Administration have been urged to clarify their policies around “biosimilars” – drugs which act in the same way as patented biological drugs, although they may not be exactly the same. Dr Ruth Lopert, who was the TGA’s Principal Medical Adviser from 2008-2011 and Director of the […]

The TGA – a watchdog with dentures?

The TGA – a watchdog with dentures?

Note: A response from the TGA was added on 28 March – see bottom of post. Questions are again being raised about the effectiveness of the Therapeutic Goods Administration as a regulator, with two Canberra University academics suggesting that “a culture of regulatory inertia” is entrenched at the TGA. *** Canberra Law School academics Bruce […]

Consumer group raises concerns about pain medicines – and the company responds

Consumer group raises concerns about pain medicines – and the company responds

Below is an article that ran earlier this week in the Crikey bulletin raising concerns about the ongoing availability of two pain management medicines, and the processes that have enabled this. Carol Bennett, CEO of the Consumers Health Forum of Australia, says the TGA has found the drugs, Di-Gesic and Doloxene, to be of questionable […]

Is the TGA out to lunch? Ken Harvey on the weight loss pill that lets you “have the cake without the calories”

Is the TGA out to lunch? Ken Harvey on the weight loss pill that lets you “have the cake without the calories”

The Therapeutic Goods Administration’s response to concerns about the marketing of a weight-loss pill, which lets you “have the cake without the calories”, suggests that the many reviews and promises of reform have not resulted in real change at the much-critiqued organisation, according to Dr Ken Harvey, Adjunct Assoc Prof of Public Health at La Trobe University. […]

A rather large wrap of recent Croakey articles: public health, health reform, media coverage of health and more

A rather large wrap of recent Croakey articles: public health, health reform, media coverage of health and more

As previously mentioned, Croakey readers are welcome to sign up for (rather irregular) summaries of posts. If you’d like to join the mailing list, please send your email or leave it below. Here is the latest compilation, covering from 6 October – December 23, 2011. The latest readership figures are now also available, showing that […]

Some VERY interesting reading: on the TGA, Ken Harvey, and pertinent questions for public health advocates

Some VERY interesting reading: on the TGA, Ken Harvey, and pertinent questions for public health advocates

Thanks to Australian Doctor for sharing a most informative Ministerial brief on the Government’s response to recent reviews recommending reforms of the TGA (it can be downloaded here, and is worth reading for many reasons, not least for the insights it gives into government processes and communications, as well as regulatory complexities and challenges). Over […]

A new guide to effective risk communication, one of the “greatest challenges” in public health

A new guide to effective risk communication, one of the “greatest challenges” in public health

(Apologies readers for glitches with punctuation; there is a gremlin at play in the system) Risk communication is one of the greatest challenges facing any public health agency; done badly it can cost lives, money, and reputations. That’s according to a new guide released by the Food and Drug Administration (FDA) and US Department of […]

The latest health & medical reading from The Conversation

The latest health & medical reading from The Conversation

Thanks to Froncesca Jackson-Webb, for providing this update of the latest health and medical reading at The Conversation. From scraping by to pizza and pie: how protein price drives obesity By Rob Brooks, Professor of Evolutionary Ecology; Director, Evolution & Ecology Research Centre at the University of NSW For the first time ever, the number […]

Some reaction to the transparency review of the TGA

Some reaction to the transparency review of the TGA

As previously reported, a review released today makes wide-ranging recommendations for improving the transparency and responsiveness of the Therapeutic Goods Administration. Below is some reaction. Dr Ken Harvey, Adjunct Senior Lecturer, School of Public Health at La Trobe University, was the CHOICE consumer representative for the review. He writes: During the consultations, and in some […]

TGA facing a shake-up (maybe), in the quest for greater transparency

TGA facing a shake-up (maybe), in the quest for greater transparency

The Therapeutic Goods Administration faces something of a shake-up if there is effective implementation of the recommendations of a review, released today, that is aimed at improving the agency’s transparency. The review was conducted over seven months and makes 21 recommendations (a summary of these is reproduced below), including that the TGA implement a more […]