TGA new complaint system: compliance notices ineffective

Two outcomes (of 16) TGA complaints have now been received.

AC-E7JS15BB/2018, submitted 3/8/18,  Brand Developers Australia Pty Ltd – Pain Erazor

 

 

 

 

https://www.youtube.com/watch?v=ye6s7qB-4Gc&feature=youtu.be

“Pain Erazor” (ATG no: 276939) won a 2017 Choice “Shonky” award, was the subject of a scathing N.Z. Consumer review, and also a TGACRP complaint (26/03/2018), sent to the TGA, for which I can find no outcome.

Another complaint was submitted to the new TGA advertising portal on 3 August 2018 (see above). In 16 August 2018 I was notified that the complaint was regarded as low priority and had been closed on 7 August 2018 by a “Compliance Notice sent with educational material”.

On 22 August 2018 I informed the TGA that the advertising appeared unchanged and asked what I should do now. The answer is appended.

AC-KD45638R/2018, submitted 15/8/18, Au Remedial, Pain®Gone and Pain®Gone Plus

I suggested this was a “high priority” complaint because the sponsor (&/or other advertisers) were recalcitrant, this type of product had previous upheld complaints, and the sponsor (and others) continued to make claims that I alleged breach the Therapeutic Goods Advertising Code 2017.

On 21 August 2018 I was notified that the complaint was regarded as low priority and had been closed on 7 August 2018 by a “Compliance Notice sent with educational material” sent to a number of advertisers.

On 22 August 2018 I informed the TGA that the advertising by Au Remedial Pty Ltd (the sponsor) appeared unchanged and asked what I should do now. The answer follows:

From: MCLAY, Nicole <Nicole.McLay@health.gov.au>
Sent: Friday, 24 August 2018 14:29
To: ‘Ken Harvey’ <ken.harvey@medreach.com.au>
Subject: RE: Outcome of therapeutic goods advertising complaint regarding Brand Developers and Transcutaneous electrical stimulation probe [SEC=UNCLASSIFIED]

Hi Ken

Our model allows for low level complaints to be handled primarily through an educative approach. Low level complaints will usually relate to an advertiser who hasn’t had contact with the TGA advertising section in the past.

A reasonable amount of time should be afforded the advertiser to review the requirements and adjust their advertising. They may get in contact with us to clarify certain aspects of the Code or their ad. Where a complaint is resubmitted within a short period of time we may choose not to proceed with that complaint.

The escalated approach to complaints, based on risk as well as advertising history, ensures our resources are focussed on the higher level cases, both in terms of public harm but also the influence on other advertisers.

The records from low level complaints become part of our data analysis. We’ll use analysis of advertising complaints to determine where further education is required.

Analysis will also be used to determine where we need to do an assurance review of a closed case.

I hope that helps.
Kind regards
Nicole

Nicole McLay FCPA
A/g First Assistant Secretary, Regulatory Practice and Support
Regulatory Practice and Support Division
Health Products Regulation Group, incl the TGA
Australian Government Department of Health
Location: Symonston, ACT
PO Box 100, Canberra ACT 2601, Australia

 

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About Dr Ken Harvey

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

One Response to TGA new complaint system: compliance notices ineffective

  1. Kolam Katha says:

    I think this advertisement gets it wrong. It should be used as Recto Analgesia – shove it up the nether area and the pain that it causes will neutralise the pain in the original area.

    The TGA could test it out as it appears very suitable for testing in their standard posture “Supine”.

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