CRP and TGA retraction orders revoked by AAT

In December 2010 I complained about a number of claims made in advertisements for Ethical Nutrients “Urinary Tract Support”. These included:

  • “Urinary Tract Support contains a combination of herbs which effectively relieve the symptoms of urinary tract infections such as cystitis”.
  • “Urinary Tract Support has a total effective rate of 96.9%, in cystitis compared to the standard oral treatment result of 88.14%”
  • “The dose to be taken depends on whether you are taking Urinary Tract Support to treat or prevent a urinary tract infection (UTI)”.

The product contained Rosa laevigata root, dry (Cherokee Rose) 1.5 g, Smilax china rhizome, dry (China Root or Sarsaparilla) 1.2 g and Lygodium japonicum whole plant, dry (Japanese Climbing Fern) 832 mg.

I argued that these claims made about this herbal combination could not be substantiated by scientific evidence, were likely to mislead the public and warranted a retraction. I also pointed out that the same claims were found on the sponsor-submitted ARTG public product summary.

In February, 2011 the Complaint Resolution Panel (CRP) agreed that these claims breached the Therapeutic Goods Advertising Code and the sponsor (Health World Limited) was request to withdraw the advertisements, the representations and publish a retraction.

The sponsor declined to comply and the CRP referred the case to the TGA.

On 27 April 2012, (12 months later) the TGA “ordered” the sponsor to comply with the CRP’s request including publishing a retraction of the claims made.

On 28 June, 2012 the sponsor requested a review of this decision. On 28 August 2012,  a delegate of the Secretary, Department of Health and Ageing essentially upheld the TGA’s earlier “order” and once more “ordered’ compliance.

The sponsor then appealed to the Administrative Appeals Tribunal of Australia (AAT). The appeal was heard on 11-13 February 2013 and a decision was handed down on June 7, 2013.

While the AAT agreed that the advertisements breached the Code they nevertheless revoked the TGA’s April 27, 2012 decision and decided not to order that the advertisements or relevant claims be withdrawn or that a retraction be published. The reasons given by the AAT were that the sponsor had withdrawn the disputed claims from advertisements (and labelling) from August 2012 and they now referred to claims being supported by Traditional Chinese Medicine (TCM).

Interestingly, it was revealed in the AAT hearing that Dr Kerryn Phelps, called by Health World, has been since 2003, a consultant to Health World and receives a commission on sales of Ethical Nutrients Urinary Tract Support.

The fact remains that the sponsor continued to promote the efficacy of this product for both treating and preventing urinary tract infection for over 18 months from the time the CRP requested them to desist and publish a retraction. This case also illustrates the long delay that the TGA often takes to review a CRP determination and the use of appeals by sponsors to postpone any definitive outcome.

The complainant, the CRP and the TGA all believed that the serious breaches of the Therapeutic Goods Advertising Code that had occurred in this case warranted the publication of a retraction. The aim was to correct the misinformation promulgated, provide a meaningful sanction to the sponsor and a deterrent to others.

I do not believe that justice has been done when a sponsor is allowed to escape publishing a retraction by refusing to comply with CRP requests and TGA “orders”, prolonging the process by appeals to various authorities and then, 18 months later, “voluntarily” changing the claims made.  This may represent “due administrative and legal process” but it certainly does not provide consumer protection. In short, the current system complaint appears heavily biased in favour of the sponsor.  The Nurofen complaint (2011/06/001) against Reckitt Benckiser (Australia) Pty Ltd is another example, still ongoing.

In a current consultation, “Regulating the advertising of therapeutic goods to the general public” the TGA has suggested that the complaint system would be improved by abolishing the CRP,  allowing the TGA to handle all complaints and strengthening their investigative and enforcement powers.

However, as the above case illustrates, there is great concern at the time taken by the TGA to process referrals by the CRP for non-compliance. The CRP has stated, “Regulation 9 orders issued by TGA for advertising complaint determinations finalised by the Panel after 1 November 2010 will be publicised on the TGA’s website”.

Since November 2010 at least 88 complaints have been referred to the TGA by the CRP because of non-compliance of which only 14 have an “outcome” recorded on the TGA website. This does not engender confidence in the TGA’s ability to deal with all complaints in in a timely and transparent manner.

Hopefully, submissions to the current TGA consultation will make useful suggestions as to how the problems documented above may be overcome.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Complementary medicine, Pharmaceutical Promotion and tagged , , , , , , , , , . Bookmark the permalink.

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