TGA reforms? Much ado about nothing.

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Rationalbrain has been eagerly awaiting the outcomes of a recent government review of the Therapeutic Goods Administration – an organisation which has copped a bit of stick on this blog for its rubber-stamping of dubious treatments and devices (see here for example). There was some hope for optimism based on this article a little while ago.

Well, the report is in, and you can read it for yourself here. There’s also an interview on Radio National (thanks Tony) with noted activitist Dr. Ken Harvey here for those who can’t stand the excitement of reading the actual text. The title of the piece on Radio National sums up the report quite well, if you ignore the tired old dog, teeth, bite metaphor: “Health watchdog gets a few more teeth, but still lacks bite“.

The review itself actually cobbles together a bunch of smaller reviews, including:

  • a review to improve transparency
  • a working group and public consultations on advertising of therapeutic products
  • an Auditor General’s report on the regulation of complementary medicines
  • an informal working group on the regulation of complementary medicines
  • public consultations on the regulation of medical devices, and
  • a health technology assessment review.

It was intriguing to read that the  reviews were undertaken not in the recognition that there is something lacking in the monitoring and regulation of bogus therapies and devices, but as ‘a commitment to open government’. This is a pretty flimsy driver for a review, and doesn’t really bode well for some real change.

And a cursory analysis of the recommendations does indeed confirm the lack of any new bite for the TGA. Here’s a brief summary of the key areas:

Communications and stakeholder engagement

This area seems to be driven by the perceived lack of understanding of the role and function of the TGA. As a result, the recommendations are only to better explain the key aspects of the TGA. Lots of good words about communications, consultation, stakeholders, continuous improvement etc etc. But nothing about actually addressing outcomes achieved by the TGA. All the recommendations have been agreed by the government, which is unsurprising given the nebulous nature of those recommendations.

Advertising

Past criticisms of the TGA are based on the inability to act on bogus efficacy claims, and the convoluted complaints process in response to such claims.  Unfortunately, the government’s statement about what they will do seem a bit wishy-washy to me. They have left it to the TGA itself to ‘develop options for consideration by Government in consultation with stakeholders‘. This seems to be bureaucratic code for ‘we don’t want to insist on regulation, let’s delay making any decision at all.”

Complementary Medicines

This is the big one. Of course it includes the issues I have been banging on about on rationalbrain. It basically revolves around non-compliance with regulatory requirements, and the TGA’s inability to enforce orders. And what has the government said it will do?

  • Prepare ‘Guidelines for the levels and kinds of evidence to support indications and claims‘. Hmmm. More guidelines. What about some laws?
  • Examine the regulatory impact of options for enhancing sanctions….”. OK, how many weasel words can we squeeze in here. 1. Examine. 2. Examine the impact. 3. Examine the impact of options. So, we are not going to apply and enforce sanctions. We are going to develop some options, assess their impact, and then examine that impact. And then?
  • Work with stakeholders to develop options to improve labelling…’. Again with the options. What have all these reviews been doing, if not discussing options?

Medical Devices

A whole host of issues exist with medical devices, and the ease with which they can be approved by the TGA. This category provides proof that the government can take some decisive action by saying that:

  • The TGA has been asked to increase the rigour of pre-market regulatory assessment of higher risk medical devices, and to ensure an appropriate level of evidential review is undertaken to assure safety, quality and efficacy of these devices
  • The way in which devices are listed by the TGA will be amended, and,
  • The level of product information on the TGA website will be increased.
Hallelujah. That wasn’t so hard, was it? Why couldn’t exactly the same recommendations be applied for complementary medicines?

Promotion of Therapeutic Products

This deals with the offering of inducements to health professionals to push a particular therapeutic product, whether drug, device or treatment. Currently this is left to the various industry bodies to self-regulate (see discussion of pharmacists recently).
What is the government going to do?
The Government’s preference is to maintain an emphasis on self-regulation and strongly supports industry’s initiative to harmonise their codes of conduct to incorporate the working group’s high level principles.
Clearly, self-regulation is such a run-away success that we want more of it. Perhaps using television, newspaper, or real estate industry self-regulation as a model will inspire confidence.

Conclusion

An assessment of the categories above? Fail, Fail, Fail, Pass, Fail.
All in all, a pretty disappointing outcome. Some forced changed with respect to devices, but in the main, more options and more consultations with stakeholders and more reviews.

I don’t think they’re really serious, do you?

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