Consequences of TGA failure to act on complaints about illegal products

Therapeutic goods must be entered by the sponsor in the Australian Register of Therapeutic Goods (ARTG)  before they can be legally sold.

The purpose is to ensure consumers have some protection against potentially dangerous or fraudulent goods &/or misleading and deceptive claims made about them.

Given the TGA’s risk-based regulatory system, the protection provided is greater (but not absolute) for goods the TGA declares high-risk such as prescription pharmaceuticals and implantable devices. The TGA evaluates these goods prior to marketing but the assessment of medical devices is less rigorous than pharmaceuticals and has many flaws as shown by the Implant files. In addition, patient experience post-market may disclose serious adverse events that had not been picked up before the product was launched as shown by the withdrawal of Vioxx (Rofecoxib) and many examples in the Implant files.

The protection provided for goods the TGA regards as lower-risk, such as complementary medicines and Class I and II medical devices, is much less. There is no pre-market evaluation. For complementary medicines sponsors merely certify that the product meets  legislative requirements: the ingredients are taken from the TGA approved list, they are manufactured under GMP standards and evidence is held for claims made. Similarly, for lower-risk medical devices, sponsors merely certify that the goods meet an essential principles check list.

The only additional checks are a limited amount of post-marketing surveillance by the TGA and the complaint process. The former has shown high rates of regulatory non-compliance and the latter is flawed by TGA inaction as shown in the cases detailed on December 3, 2018.

If a medicine or device is marketed in Australia without going through the above process it is being supplied illegally (a breach of the Therapeutic Goods Act 1989 s.42DL(1)(g)) and the potential for harm is much greater.

This is a serious breach of the law and I cannot understand why the TGA has failed to act on the cases appended.

The critique by Commissioner Haynes on the regulators of the financial services industry is equally applicable to the TGA. A failure to enforce the law undermines the authority of the regulator whose fundamental responsibility is to do just that. It also encourages others to break the law, leading to a race to the bottom.

Cases 1-3 and 6 are illegal imports from the U.S. where the regulation of supplements is even weaker than Australia and adulteration is rife. For example, GNC the country’s largest retailer of supplements, has recently agreed to pay $2.25 million in a settlement with the Department of Justice as part of an ongoing FDA crackdown on supplements that contain hidden drug ingredients, harmful compounds or don’t truthfully list their ingredients.

Case 4 is an illegal import of an Ayurvedic medicine, of which others have caused lead and mercury toxicity:

Case 5 is illegal supply of a product containing ingredients listed in Schedule 3, 4 or 8 of the Australian Poisons Standard.

In addition, the TGA has found dangerous prescription drugs in illegally supplied Chinese herbal medicines:

As have others:

Researchers have also found dangerous plants in herbal medicines and supplements:

Why doesn’t the TGA act?

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Complementary medicine, Medical Devices and tagged , , , , , , , , , , , , . Bookmark the permalink.

2 Responses to Consequences of TGA failure to act on complaints about illegal products

  1. Ian Watkinson says:

    Hi Ken,
    I advocated for a widow who sat on a massage chair in a shopping centre in Melbourne and without any warnings from the salesperson subsequently fractured her pelvis and will never walk the same again. The lady had an underlying bone weakness and did not stop to think that the force of the massage chair would be a risk to her safety.’

    I reported this to the TGA on her behalf and was told that because the manufacturer’s offshore website, in the opinion of the TGA, did not make therapeutic claims the case would be transferred to the ACCC.

    Later I spoke to the ACCC who said that they would not report back to me, that it is not their policy to report back to consumers, especially as I was not the person who was injured. Given the elderly lady could not use a computer and had no idea of how to make the complaint it was obvious to me that she needed a helping hand. I had no vested interest in helping her other than I had been informed of the incident and felt a strong sense of the injustice she had been experiencing after being told by the retailer that she had no chance of proving that this had happened as there was no CCTV of the incident. They dismissed her when an ACCC mandatory incident report should have been lodged.

    Now two years plus later, the lady informs me that she has never had a call from the ACCC or the TGA. How rude! She expects she will never hear back from the company who’s product, I’m sure, was being sold as having some therapeutic benefit, despite the off shore company’s website supposedly not reflecting this.

    There is an ARTG code for massage chairs but according to the TGA it does not have to be registered if no therapeutic claims are being made.

    I get the feeling that for both the TGA and the ACCC that they just don’t really care about this poor old lady. That is is all too complex for them to investigate, even though I had done most of the leg work for them. Shirley, the lady who was injured, would say the same but is at the very least least grateful that I tried on her behalf to get some action…….sadly to no avail.

    • This is a sad but all too common story. The ACCC claim that they lack the resources to follow up most complaints that allege a breach of Australian consumer law. They focus on the most egregious or those they feel will send a message to industry. In a recent presentation, Nicholas Heys, Deputy General Manager, Enforcement Coordination, ACCC noted they receive around 3200 complaints and enquiries per year; of these around 1100 are assessed, of these 120 get in-depth investigations, and the outcome is 30 matters taken to court plus 30 enforceable undertaking or infringement notices.

      All complaints are logged for trend analysis but clearly this provides little satisfaction to complainants. At the very least the complaint should be acknowledged, and the complainant thanked.

      The TGA also lacks resources to deal with most complaints; their strategy is to declare over 90% of complaints ‘low priority’ and close them by sending an ‘educational’ letter which also informs the company complained about that there will be no follow-up! Not surprisingly, this has little effect on companies who continue to break the law.

      What is needed is an incremental demerit points system similar to driving offences with cancellation of the product licence once repeat offences reach a certain number of points.
      There is to be a review of the TGA complaint system soon; I encourage you to make a submission.

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