Can we have confidence in the Therapeutic Goods Administration?

Jun 30, 2021

Two recent decisions by the TGA have further reduced the confidence that health professionals and consumers have in the regulation of complementary medicines. The first was allowing complementary medicines as a reward for people vaccinated against COVID-19. The second was approving a TGA assessed (Aust L(A)) application for Caruso’s Prostate EZE Max.

On 7 June 2021, the TGA amended the Therapeutic Goods Advertising Code to allow rewards, including complementary medicines, to be given to people vaccinated against COVID-19. The TGA’s rationale was that complementary medicines are low-risk, large complementary medicine companies might positively influence vaccination rates, and the regulatory changes are time-limited (they cease on 31 December 2022).

Another view was that this decision would open the floodgates to complementary medicine companies and pharmacies offering dubious immune boosters over winter and ineffective homeopathic products that might encourage the use of homeopathic vaccines.

Ironically, in 2017 a complaint about Chemist Warehouse distributing free samples of complementary medicines at the AFL grand final resulted in the TGA “working” with Chemist Warehouse to ensure that in 2018 the samples only contained allowed sunscreens. This intervention appears to have been forgotten.

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On 26 May 2021, Caruso’s Prostate EZE Max became the first herbal complementary medicine to receive an Aust L(A) listing. The TGA assessed pathway was introduced on 19 March 2018. It allowed sponsors of complementary medicines to list their products using intermediate-level health claims if supported by a pre-market assessment of scientific evidence by the TGA. The aim was to encourage more evidence-based products and help consumers choose them by designating them AUST L(A) and allowing a “TGA assessed” symbol on the pack and promotional material.

The Caruso’s product contains herbal extracts of Prunus Africana (Pygeum), Serenoa repens (Saw palmetto extract), Epilobium parviflorum (willowherb), Cucurbita pepo (pumpkin seed oil), and lycopene (found in tomatoes and some other red fruits and vegetables).

The TGA assessed indication is, “For the relief of nocturia (night-time urinary frequency) associated with medically diagnosed benign prostatic hypertrophy (BPH).” My colleagues and I are unaware of any published evidence that supports the TGA-assessed indication. We asked Caruso’s if they had conducted unpublished, more definitive, clinical studies on their product. We did not receive a response.

The TGA was also asked for more information about their decision. They said they do not usually disclose details of a company’s application and dossier to people outside that company, but this information may be accessible under the Freedom of Information Act.

This raises serious questions of transparency and consistency of TGA decision-making. If Caruso’s has provided more definitive (albeit unpublished) clinical trial results to the TGA, these should be critically assessed and have a summary placed in the public domain, as the TGA does for newly evaluated prescription medicines (AusPARs). This would allow health professionals and consumers to compare the Caruso’s herbal product with prescription medicines. Why should the TGA’s assessment of complementary medicines be less transparent and inconsistent with prescription medicines?

Three years after the AUST L(A) pathway was introduced, there are only two AUST L(A) products listed on the Australian Register of Therapeutic Goods (ARTG). One is controversial, Caruso’s Prostate EZE Max, the other is unremarkable, Care Pharmaceuticals Hydralyte Orange Flavoured Effervescent Electrolyte Tablets.

The paucity of AUST L(A) products after 3 years suggests that the industry considers a better return on investment comes from spending money on celebrity endorsement and promotional hype rather than undertaking research and paying the higher fees required for AUST L(A) listing or AUST R registration.

The Therapeutic Goods Amendment Bill (No. 4) 2000 allowed low-risk medicines (labelled AUST L) to be listed automatically in the Australian Register of Therapeutic Goods (ARTG) following self-assessment of regulatory compliance. Most listed medicines are complementary medicines.

A 2021 complementary medicine industry snapshot showed a revenue of $5.69 billion with a growth of 15% per annum and export revenue of $1 billion. There are now over 10,000 listed medicines (mainly complementary medicines) on the Australian Register of Therapeutic Goods (ARTG), with around 2000 new listings each year.

An application for listing costs the industry $860; the annual charge to keep it on ARTG is $1,160, hence the TGA’s yearly income from listed products is around $13.3 million. The industry adds this cost of regulation to the price consumers pay. But in return, consumers are not protected from products that don’t work, nor rampant unethical promotion from an exploitative industry.

There are only two TGA checks on the regulation of listed products: a small number of post-marketing surveillance 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, about 75% of products evaluated have consistently been found non-compliant, mainly because companies were unable to produce evidence to substantiate claims for efficacy. Delisting non-compliant products merely result in companies relisting the same or similar products.

The TGA dealt with an increasing backlog of complaints by ceasing to deal with individual complaints. Consultants said it was not in the public interest to provide more resources. As a result, the TGA now ignores most complaints about unethical advertisements and fails to apply timely and significant penalties to most Code breaches.

Thus, there is little incentive for complementary medicine providers to change their ways. So, what’s the harm? So-called low-risk products do not mean there is no risk. Direct harm is caused by poorly disclosed adverse events, such as allergic reactions to Echinacea, liver failure from high dose green tea supplement, and interaction with conventional medicines. Indirect harm is caused by consumers forgoing more evidence-based remedies (often to the detriment of their health) and wasting their scarce financial resources on ineffective products. Meanwhile, research that might produce valuable products from indigenous and traditional medicines is forgone.

Given this, it is not surprising that the confidence of GPs and consumers in the TGA’s regulation of complementary medicines is low. Recent decisions by the TGA reported above, are likely to reduce this confidence even further.

Paul Gibson, CEO of Complementary Medicines Australia, has explained the current policy settings: The industry, the CMA and the TGA work together to promote the appropriate regulation and advancement for our world-class sector, one that supports a growing number of jobs nationally and internationally”.

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