My resignation from the Therapeutic Goods Advertising Consultative Committee (TGACC) was precipitated by the non-response of Adj Professor John Skerritt, Deputy Secretary, Health Products Regulation Group, Department of Health, to long-standing issues raised yet again at the Skepticon 2020 regulatory panel session (see below). These include ineffectual and token enforcement of complementary medicines violations by the TGA.

The problem has got worse with the TGA’s recent implementation of recommendations from the Review of the Therapeutic Goods Advertising Framework. The TGA has now got rid of its backlog of complaints by closing all complaints received (including new ones) with the following response.

‘Your complaint has been finalised. The information you provided will be used by the TGA to inform compliance and enforcement activities under the TGA’s updated advertising compliance framework. The TGA is transitioning towards responsive regulation by utilising an intelligence led, risk-based approach to compliance activities. Thank you for bringing this matter to the attention of the TGA’.

Why would anyone bother to submit any more detailed complaints now this is the only response? Presumably, the TGA hopes for just this reaction. They will then be able to cite a falling-off of complaints as ‘evidence’ that unethical advertising has been brought under control. See the articles below.

• Ken Harvey: Review of the Therapeutic Goods Advertising Framework
• Top doctor resigns TGA role over concerns with policing of fringe medicine
• Angry CHOICE rep quits TGA
• Why I quit TGA committee

• 

My talk (which sets out the issues) is available: Ken Harvey: Background to the Review

A video of the session is available below (Q&A starts at 51:57 minutes):

My resignation letter. Response from Adj Prof John Skerritt and Health Minister Greg Hunt

See also the appended correspondence:

——— Forwarded message ———
From: Kenneth Harvey <kenneth.harvey@monash.edu>
Date: Thu, 12 Nov 2020 at 15:51
Subject: Re: Rapid Recovery Hangover Relief – Outcome of advertising complaint – AC-BGKWMZBG/2019
To: TGA Advertising <tga.advertising@tga.gov.au>

Dear TGA advertising people,

I was intrigued by your appended response to this complaint, first sent to the TGA on 10 September 2018 and again on 31 October 2019.

This product is still being advertised today, e.g.

• https://www.chemistwarehouse.com.au/buy/89651/rapid-recovery-hangover-relief-5-dose-20-capsules
• https://www.mychemist.com.au/buy/89652/rapid-recovery-hangover-relief-2-dose-8-capsules

It is still listed on the ARTG (no 297954) with a permitted indication: ‘Helps decrease/reduce/relieve symptoms of occasional hangovers’, despite the lack of evidence for this indication. 

Yet, your new advertising framework lists ‘hangover products’ as priority 2! 
Why have you closed this complaint, but taken no action?

Also, I have pointed out that additional hangover products have recently been listed on the ARTG

• ARTG no: 314758 – N+ Hangover Relief  See: https://mrvitamins.com.au/products/nadvita-9354721000063
• ARTG no: 304293 Hangover Relief  See: https://www.bodyarmour.com.au/

Why have you not asked the sponsors to justify the claims made and the ‘traditional’ indications cited

Do you believe these products are appropriate, given public health concerns about Australian alcohol consumption?

Please respond. Or, should I be writing to the Minister of Health (and Shadow Minister) about these matters?

Sincerely,

Ken

On Thu, 12 Nov 2020 at 14:59, TGA Advertising <tga.advertising@tga.gov.au> wrote:

Dear Sir/Madam,

Your complaint (Case Ref. CC-39UT49KT/2019*) received on 31/10/2019 in relation to the advertiser, The Trustee for CW IP Unit Trust T/as Chemist Warehouse for the advertising of Rapid Recovery has been finalised.

The action taken in relation to this complaint was: Reviewed in accordance with the updated advertising compliance framework.The outcome was: Case closed.

The TGA has closed this complaint and the information you provided will be used to inform the compliance activities of the TGA.

Our new advertising compliance framework describes the TGA’s intelligence led, risk based approach in responding to reports of non-compliance.

Compliance activities under the new framework are focussed on three key priority areas. 
For more information, please visit our approach to managing advertising compliance.\

While your case has been closed, the information you provided will help the TGA to understand what issues are causing the most harm to Australian consumers, and where to focus our compliance monitoring and enforcement efforts.For more information on the TGA’s Regulatory Compliance Framework, please visit the TGA website.

Thank you for bringing this matter to the attention of the TGA.

Kind regards
Advertising Compliance Section
Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606

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