Issue 27 / 25 July 2011

JOURNALISTS have long known that the T in TGA doesn’t stand for transparency. Getting an answer from Australia’s drug regulator in response to even the most routine query can be a task of Sisyphean proportions.

Questions to the Therapeutic Goods Administration must generally be submitted in writing, meaning there is little opportunity to clarify the response (assuming there is one), and journalists are almost never permitted to speak directly to the people who actually work in drug regulation and might as a result be best equipped to explain the issues to them.

You might think that how a regulatory body deals with the media is not the most pressing issue but, in my experience, organisations that adopt a paranoid and defensive approach to journalists don’t tend to do a very good job of informing anyone else either.

When the organisation’s key role is regulating drug safety, the provision of quality information to health practitioners and the public would seem to be a pretty important part of what they do.

So, late last year when the federal government set up a review designed to improve TGA transparency, it was welcome news — and not just to journalists.

The many public submissions showed that we in the media were by no means alone in our frustration at the difficulty of getting reliable and timely information from this often secretive organisation.

It might be no surprise that pharmaceutical companies complain about the drug regulator’s communication of its processes and decisions but, when professional associations, individual doctors, consumer health advocates, other government bodies and the media are all joining in the chorus, it seems fair to assume you have a problem.

Certainly, the review panel’s final report released last week would seem to indicate that is the case.

The panel, led by former Commonwealth Ombudsman Professor Dennis Pearce, made 21 far-reaching recommendations to government, most of them focused on improving the organisation’s communication with the public and with stakeholders.

Although the report said the TGA had taken steps to improve transparency in recent years, it was clear there was still a way to go, with recommendations that it provide clearer information on its regulatory processes, work to improve product labelling and reporting of adverse events, and overhaul its website to ensure information was up-to-date and accurate.

One priority should be to explain the difference between registered and listed products, the panel found, as consumers often wrongly assumed that listed products (including many complementary medicines) had been evaluated for efficacy when that was not the case.

All good suggestions. However, with the panel noting some recommendations could not be implemented without additional resources, it will be interesting to see if the sweeping cultural change this organisation needs can actually be achieved.

Jane McCredie is a Sydney-based science and medicine writer.

Posted 25 July 2011

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