‘A classic of TGA bureaucratic obfuscation:’ Harvey


business owners holding up red cards for reprimand

Infringement notices handed to pharmacies including Chemist Warehouse over weight loss product advertising were among incidents noted in a new TGA report

But stakeholders disagree over how well the TGA is managing non-compliant advertising.

The TGA has released its Advertising Compliance Annual Report 2020-21, with a focus on appropriate advertising around COVID-19 and medicinal cannabis.

The report notes that from 1 November 2020, the TGA moved to its new compliance framework.

There was a decline in reports of non-compliance received by the TGA for alleged advertising breaches: from 2,227 in 2019-20 to 2,074 in 2020-21.

Over the year 2019-20 3,047 cases were created and 1,608 closed; in 2020-21 1,140 cases were created and 2,354 closed.

During 2020-21, the TGA issued 127 infringement notices for alleged breaches of the therapeutic goods advertising legislation or conditions of registration related to advertising.

The top reasons for issuing an advertising related infringement notice were the promotion of illegal therapeutic goods to consumers (therapeutic goods that should have been included in the ARTG but were not); and unauthorised use of prohibited and restricted representations.

“COVID-19 continued to be the major focus for advertising compliance for the first three quarters of the year,” the TGA said.

“This included a range of strong and timely actions with warnings, cease and desist notices and a number of cases proceeding to infringement notices.”

The TGA issued 39 infringement notices to 16 entities, totalling $412,056, and contacted more than 189 entities to issue warnings about alleged non-compliance on the subject of COVID.

It issued a directions notice for the unlawful advertising of Ivermectin as a cure for COVID-19; removed several social media posts that were unlawfully promoting the use of Ivermectin and/or Hydroxychloroquine for COVID-19; and took action on the remediation of a website, including removal of references to a homeopathic COVID-19 immunisation product, and references to HIV and EBV.

Another website was removed after it was marketed as a site for other companies to purchase COVID-19 test kits.

On non-COVID-related matters, the TGA issued 88 infringement notices to 12 entities totalling $943,344; and contacted more than 232 entities and issuing warnings regarding alleged non-compliance.

It also removed prohibited and restricted representations about non-compliant complementary medicines advertised on a website.

“The entity was of particular concern given it had an application for a manufacturing licence refused,” said the TGA.

“The website is now compliant, however we will continue to monitor it as part of our assurance program.”

Several hundred advertisements were removed from online shopping platforms.

In the report the TGA also focuses on weight loss products, and medicinal cannabis.

It issued issuing nine infringement notices to four entities totalling $119,880.

These included four notices issued to Chemist Warehouse and My Chemist websites regarding advertising of Fatblaster Clinical; one to Junction Rx trading as My Community Pharmacy over Fatblaster Apple Cider Vinegar and Garcinia Max; and two to Epharmacy Group Pty Ltd, again over Fatblaster Clinical.

Cat Media were handed two notices regarding Fatblaster Original and Fatblaster Apple Cider Vinegar and Garcinia Max.

The TGA also reviewed more than 450 complaints over medicinal cannabis advertising.

“It is anticipated COVID-19 will continue to be central to our work in the 2021-22 year and we will continue to be able to demonstrate our responsiveness and agility in our regulatory approach,” the TGA concluded.

“Now more than ever, we must continue to direct our focus toward public health and safety and ensuring that Australians can continue to be confident that advertisements are truthful and support the appropriate use of therapeutic goods.”

Stakeholder reaction to the report varied.

“I believe the TGA are doing a good job in balancing the response to COVID and advertising compliance,” said Carl Gibson, Chief Executive Officer, Complementary Medicines Australia.

“Complaints are now categorised, and high-risk breaches are prioritised, as they should be.

“With multi-million dollar fines and enforcement actions imposed by the TGA last year, anyone who thinks the TGA isn’t taking advertising complaints seriously is in cloud cuckoo land.”

But public health physician Ken Harvey criticised the report as “incomplete”.

“The TGA’s 2020-2021 advertising compliance report is a classic of TGA bureaucratic obfuscation,” Dr Harvey told the AJP.

“The data and tables are incomplete, and the numbers do not add up. The only conclusions that can be drawn is that, in 2021 the TGA has focused on COVID-19 and medical cannabis complaints and, apart from token efforts, they have neglected the far more common advertising violations of complementary medicines.

“They consistently regard the latter as low priority, despite their frequency and the consumer detriment caused.”

He noted that from July to October 2020 the TGA created 830 cases of alleged advertising violations: 78% were classified as low priority; 20% medium, 2% high, 0% critical.

“No further information was provided about these cases,” he said.

 “From 1 November 2020 to 30 June 2021 the TGA created 271 ‘cases’ against their new ‘intelligence informed’ compliance priorities; mainly COVID-19 (58%) and medical cannabis (25%). They ‘closed’ 649 ‘cases’, presumably including those from earlier times (Table 5).

“Analysis is difficult because the TGA has not spelled out the closure of new cases compared to those received previously. For example, they report meeting 100% of KPIs for 447 high priority completed cases but it is unclear from where these cases were derived.

“They also reported 585 COVID-19 cases closed from 1 November 2020 to 30 June 2021, yet only 341 allegations were received, and 129 cases were created.

“They reported action taken from 1 November 2020 to 30 June 2021 on 1519 cases but again it is unclear when these cases were received and how many are still outstanding.

“For those cases closed in 2020-21, where the TGA identified non-compliance, the issues were categorised into breaches. They identified 935 alleged breaches of the Act from 259 cases (most commonly advertising goods not on the register) and 157 alleged breaches of the code from 54 cases.

“The small number of Code breaches identified by the TGA (compared to those commonly alleged by complainants) appears to reflect the TGA’s assessment that these complaints were of low priority.”

Dr Harvey said that the “tables are incomplete and the numbers given do not add up”.

“The only conclusions that can be drawn is that, in 2021 the TGA has focused on COVID-19 and medical cannabis complaints and, apart from token efforts, they have neglected the more common advertising violations of complementary medicines,” he said.

“They consistently regard the latter as low priority, despite their frequency and the consumer detriment caused.”

 

Previous Going the extra mile
Next World news wrapup: 7 October 2021

NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.

2 Comments

  1. Ken Harvey
    06/10/2021

    See also: Harvey K. The Australian obesity epidemic and the regulation of complementary medicine weight loss products. ANZJPH, 30 September 2021. https://onlinelibrary.wiley.com/doi/full/10.1111/1753-6405.13161

    • Getajob
      07/10/2021

      lol. The quality of research is very poor.

Leave a reply