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 Therapeutic Goods Administration (TGA) regulates more than 10,000 listed products, mainly complementary medicines. Unlike registered prescription medicines, listed products have no pre-market evaluation. The TGA ‘trusts’ each product’s sponsor to obey the rules. There are only two TGA checks on the regulation of listed products: a small number of post-marketing reviews and the advertising complaint system.
TGA post-marketing surveillance assesses around 160 listed products a year (out of more than 10,000). Over the last five years, on average, around 75% of products assessed have consistently been found non-compliant, mainly because companies are unable to produce evidence to substantiate claims for efficacy.
Since July 2018, the TGA has had enhanced investigative and compliance powers to take over the advertising complaint system. The previous Complaint Resolution Panel (CRP) had upheld virtually all the complaints it received but had no power to sanction companies which repeatedly breached the Therapeutic Goods Advertising Code. While there was support for the TGA takeover, there were also concerns that the TGA had rarely acted on non-compliance with Panel determinations previously forwarded by the CRP.
Under the new complaint system, the TGA classified most complaints as ‘low priority’ and closed them by sending an ‘educational letter’ to the company concerned. This letter reminding the company of their regulatory obligations, but also pointed out that no further action would be taken. In the first year of the TGA takeover, there were around 2,000 complaints; in the second year, there were more than 3,000. Delays in dealing with complaints increased.
A review by consultants recommended that the TGA should stop dealing with individual complaints. As a result, outstanding and most new complaints were now closed by sending complainants a letter stating that their complaint will be used for ‘intelligence’ to set priorities.
‘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 also 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
- Complementary medicines advertising policy Part I: unethical conduct in the Australian market before July 2018
- Complementary medicines advertising policy Part II: unethical conduct in the Australian market after July 2018
- Launch of TGA Advertising Hub – Initial experience of submitting complaints
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):
See also the appended correspondence:
——— Forwarded message ———
From: Kenneth Harvey <firstname.lastname@example.org>
Date: Thu, 12 Nov 2020 at 15:51
Subject: Re: Rapid Recovery Hangover Relief – Outcome of advertising complaint – AC-BGKWMZBG/2019
To: TGA Advertising <email@example.com>
Dear TGA advertising people,
This product is still being advertised today, e.g.
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?
On Thu, 12 Nov 2020 at 14:59, TGA Advertising <firstname.lastname@example.org> wrote:
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.
Advertising Compliance Section
Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606