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Therapeutic Goods Administration Challenged to Do Its Job

By Mal Vickers

Despite a number of reforms, the TGA’s system of labelling therapeutic goods confuses consumers and its complaints resolution process fails to deter repeat offenders.

The complementary industry’s regulator, the Therapeutic Goods Administration (TGA), came under pressure at the 2018 Australian Public Health Conference held in Cairns. During a panel session on “Contested Policy: Complementary Medicines and Advertising Reform” John Skerritt, Deputy Secretary for Health Products Regulation in the federal Department of Health (which oversees the TGA), promoted reforms that the TGA had recently or was about to implement. These include the triaging of advertising complaints, increased investigation and enforcement powers, the new permitted indications scheme, and the proposed AUST L(A) product category. The latter is a new label for complementary medicines that have submitted clinical trial data to the TGA and been assessed to work.

Among these announcements was news that the TGA was finally carrying out a review of gummy supplements, a confectionery product promoted to parents as “gummy vitamins that are packed with healthy nutrition”. The first advertising breach for “Kids Smart Vita Gummies” is dated 2012.

Monash University researcher Alanna Rottler presented a survey of consumer knowledge of the TGA and the regulation of medicines. Ninety-one per cent of the 273 respondents could not make an informed choice about therapeutic goods using the existing AUST-L and AUST-R labels because they had not noticed these small-print labels or had no idea what they meant. For those readers similarly unaware, AUST-R applies to medicines assessed for safety and efficacy (typically prescription medicines) while AUST-L only means that the ingredients supposedly can do you no harm (vitamins, herbal extracts, supplements etc.). Efficacy is untested prior to the sale of products with an AUST-L label.

I presented an analysis of the decisions of the Complaints Resolution Panel (CRP) between 1999 and 2017 before its abolition on 30 June 2018. More than 2000 determinations of complaints about the advertising of therapeutic goods were available for analysis. The CRP referred 755 complaints to the TGA for non-compliance, or to save duplicating CRP determinations where the same advertising problem later reappeared. Referrals to the TGA were essential for enforcement action as the CRP had no powers to enforce its determinations. I found that the TGA lacked transparency as it published the outcomes of only 80 CRP referrals (11%).

One company, Pharmacare Laboratories Pty Ltd, had the greatest number of complaints (104) upheld by the CRP. This was three times more than Swisse (33) and Blackmores (32). Readers may recognise these Pharmacare products from letterbox advertisements for FatBlaster Magnet, Super Krill Oil, Horny Goat Weed for Him, and Horny Goat Weed for Her.

Each year, Pharmacare has had complaints upheld by the CRP following similar breaches of the code. However, the publication of detailed CRP determinations appears to have had no impact on the company’s behaviour. The CRP referred 21 Pharmacare complaints to the TGA for regulatory action, but only two outcomes have been published by the TGA. The most recent is dated 2014; meanwhile, misleading promotions have continued.

I also noted that the TGA’s handling of complaints is much less transparent than the CRP system it replaced. The TGA publishes no information on complaints that it decides are “low priority”, although they are likely describing breaches of the law. The TGA closes these complaints by sending an “education letter” without follow-up to see whether this achieved compliance. It usually does not.

A lively Q&A session took place after the presentations. Terry Slevin, CEO of the Public Health Association of Australia, noted the importance of the research presented by Rottler and myself, which held the TGA accountable. He was also pleased that the head of the TGA had attended and engaged in the forum.

The debate about the TGA’s handling of complaints continues. The TGA argues that its priorities are public health and safety, not the financial interests of consumers. Yet if the TGA fails to act on companies that consistently break the law, misleading and deceptive promotion will continue.

Mal Vickers is a Researcher in the School of Public Health, Monash University.