FOI application to view TGA “compliance notice sent with educational material” for complaint AC-KD45638R/2018 (Paingone)

Paingone TV Commercial Australia (uploaded 07/01/2018)

This Freedom of Information (FOI) application reveals that the TGA summarised a detailed complaint alleging numerous specific breaches of the Therapeutic Goods Advertising Code 2015 by sending one sentence to the advertisers, “The complaint alleges the advertisement may be misleading to consumers and a reference to scientific information is misleading”.

Given the lack of detail the TGA sent to the advertisers, and advice that the complaint would not be pursued further, it is not surprising that the advertisements remain largely unchanged.

Under the previous complaint system, the CRP forwarded the entire complaint to the advertiser (deidentified if requested). They also provided a public determination on what aspects of the complaint were justified and specific advice on what claims should be removed to comply with the Code. This was educative both for the advertiser, the complainant and the industry. The TGA’s new complaint system provides none of these benefits. It actively discourages complainants. Why bother with submitting a detailed complaint if this information is not passed on to the advertiser and no action results?

The new complaint system has now been in operation for 6 months. It has proved far worse than the system it replaced. Hopefully, it will be reviewed by a new government.  

The background to my FOI application follow.

On 15 July 2018, I submitted a detailed 112 page complaint about the advertising claims of “Pain®Gone”. I noted that this medical device had previously had a complaint upheld by the Complaint Resolution Panel (CRP). However, the sponsor (and others) continued to make claims that I alleged breached numerous sections of the Therapeutic Goods Advertising Code 2015.

My complaint contained the relevant CRP determination, a critique of the unpublished clinical trial used to promote the product and a 2001 Pain Review article, “Transcutaneous Electrical Nerve Stimulation (TENS) and TENSlike devices: do they provide pain relief?” This article noted that information on the clinical effectiveness of high-voltage TENS-pens was lacking; only two small uncontrolled trials had been published and randomized controlled clinical trials were needed.

From: https://www.paingonepen.com.au/ uploaded 07/01/2019

The TGA assigned a low priority to this complaint and it was closed over the period 24 July 2018 to 2 August 2018 by a “compliance notice sent with educational material” to various advertisers.

On 22 August 2018, I informed the TGA that the advertising for this device was unchanged. I was told that a reasonable amount of time should be afforded the advertiser to review the requirements and adjust their advertising. The TGA also noted that records for low priority complaints would eventually be analysed to see if further education was required. To-date (07/01/2019) the advertising remains largely unchanged.

On 17 October 2018 I submitted a FOI application to view the educational letter the TGA sent to the advertisers of this medical device. It noted that I had requested a copy of this letter from the TGA as I was concerned that the detailed allegations of Code breaches may not have been passed on. The TGA had refused this request. They stated that the details (nature) of complaints were included in correspondence with the advertiser without forwarding the complaint itself.

On 24 December 2018, I received the result of my FOI application. My detailed complaint was summarised in one sentence, “The complaint alleges the advertisement may be misleading to consumers and a reference to scientific information is misleading”.

The TGA letter did contain the screen shots of advertising material I submitted but without any of the information I provided about why the claims made breached various sections of the Code. The TGA letter also listed four sections of the Code that may have been relevant (with no explanation) whereas I had alleged breaches of ten.

The TGA letter merely recommended that the identified advertisement should be reviewed as soon as possible to ensure it complied with the law. The TGA also advised that they would not be pursuing this complaint any further at this time, but advertising may be monitored for compliance and any future complaints will be considered on their merits.

I dispute the TGA’s assertion that the details (nature) of my complaint was included in correspondence with the advertiser. Given the lack of detail the TGA sent to the advertisers, and the advice that the complaint would not be pursued further, it is not surprising that the advertisements remain largely unchanged.

Finally, I fail to see why the TGA cannot send the original complaint (in its entirety) to the advertiser (de-identified if requested), as distinct from a brief and unhelpful summary?

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About Dr Ken Harvey

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

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