Non-transparent outcome of TGA complaint: Sawyer Extractor™ Pump for Snake Bite, AC-22VHXCSG/2018

Screen shot 03/09/2018:
https://www.survivalsuppliesaustralia.com.au/products/sawyer-extractor-kit.php

On 30/07/ 2018 I submitted that this was a “critical” complaint because it undermined accepted public health messages about the treatment of snakebite and was likely to lead to harm or injury if the claims were relied upon.

I noted the product was advertised in a number of publications:

  • https://outdooryou.com.au/view/?id=36
  • https://youtu.be/hM0FFpy-J_E (not in Australian jurisdiction)
  • https://survivalsuppliesaustralia.com.au/products/sawyer-extractor-kit.php
  • https://nethos.com.au/index.php?rt=product/product&product_id=146
  • https://backpackinglight.com.au/sawyer-venom-extractor-kit.html
  • https://pinterest.com.au/pin/413205334553309465/
  • Etc.

On 31/08/2018 I was notified by the TGA of the following outcomes of my complaint about Sawyer Extractor Bite and Sting Kit AC-22VHXCSG/2018:

AC-22VHXCSG/2018The action taken in relation to this complaint was: Formal contact requiring immediate action, Warned – Compliance achieved without formal action – closed, (Advertiser not specified

AC-22VHXCSG/2018Warned – Compliance achieved without formal action – closed, Outdoor You (Sawyer in Australia), 

AC-22VHXCSG/2018, Warned – Compliance achieved without formal action – closed, Backpacking Light, 

Today (03/09/2018) I note this product is still being advertised by:

Conclusion:

Compliance has been achieved on some sites complained about; others may be in progress.

But if the complainant notes there are additional sites  involved (as above via etc.) does the TGA actually perform a search for additional offending product themselves? It appears they do not.

More importantly, even for what the TGA agreed was a critical complaint warranting immediate action by formal contact, there is no useful transparency about the product complained about.

The TGA “outcomes” web pages  merely list 190+ cryptic reference numbers of which all except three are assigned “low priority” with the note, “Compliance Notice sent with educational material”.  Low priority complaints neither list the advertiser (responsible entity) or the therapeutic good complained about.

Because a compliance notice was sent, I presume that the advertisements complained about were judged to have breached the Therapeutic Goods Advertising Code. However, it is impossible for consumers or health professionals to find out what products were involved, let alone whether compliance was achieved.

The three outcomes listed above for “critical” complaints, merely state, “Warned – Compliance achieved without formal action – closed. Two outcomes listed the advertiser, but to find out the product complained about one had to click on the reference number link.

Neither the search function provided in the “outcomes” web pages or the main TGA search allow a search for a particular product complained about or even the category of “critical” complaints.

This means that the TGA provides no help to consumers concerned that they have  purchased a product with upheld complaints, or consumers who wish to check the status of a product currently being advertised, even if the product has been the subject of a “critical” complaint.

In short, the TGA’s new complaint system provides much less transparency than the old Complaint Resolution Panel (CRP).

In addition, the TGA has failed to provide outcomes for large numbers of complaints sent by the CRP to the TGA because it was thought that regulatory action was needed.

This is appalling consumer protection.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Medical Devices and tagged , , , , . Bookmark the permalink.

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