Skepticon 2019, TGA, ACCC, Regulatory Panel Discussion

The Australian Skeptics National Convention returned to the University of Melbourne’s Carrillo Gantner Theatre on 7th and 8th December 2019. One feature was a regulatory panel discussion: Could Australian regulators better protect consumers from misleading and dangerous advertising of products making therapeutic claims?

Ken Harvey, Session Chair
Ken Harvey (Chair) introducing case studies for discussion by the panel

Background: From July 2018 the Therapeutic Goods Administration (TGA) took over the advertising complaint system from the Complaint Resolution Panel (CRP). The TGA were given increased compliance and enforcement powers that the CRP lacked.

The TGA also declared certain products that had received numerous complaints not to be therapeutic goods, thus hand-balling regulatory responsibility to the Australian Competition & Consumer Commission (ACCC). The latter complained they were already overloaded, and a specialist regulator was more appropriate.

Meanwhile, controversial promotion of products at the food-medicine interface, such as self-declared sports supplements and medical foods, highlighted problems with Food Safety Australia New Zealand (FSANZ), State and Territory Food authorities, and their interrelationship with the TGA. There was also concern about the TGA’s new complaint system.

Panel members:

  • Nicholas Heys, Deputy General Manager, Enforcement Coordination, Australian Competition & Consumer Commission (ACCC).
  • John Skerritt, Deputy Secretary for Health Products Regulation, Australian Department of Health.
  • Julie Woods, Discipline Leader (Nutrition), Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University (unfortunately unable to make it due to illness).

Chair and Session organiser:

Presenters:

Photos

Basia Diug
Basia Diug
Paulina Stehlik
Paulina Stehlik
Mal Vickers
Mal Vickers
The Monash Team: Mal, Basia & Ken
The Monash Team: Mal, Basia & Ken
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TGA decision to grant Special Access Scheme B approval for suspended breast implants

Breast implants

I recently submitted a complaint to the TGA about the promotion by JT Medical of ARTG suspended POLYTECH Breast implants (AC-G8RWXAES/2019). I was concerned that these implants were being promoted to the public with no mention of the risks of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

The TGA’s decision to suspend certain breast implants was in response to the increasing incidence of BIA-ALCL and new evidence correlating BIA-ALCL to textured implant devices.

Despite this evidence, following application from six surgeons, the TGA has allowed 36 patients access to suspended breast implants via Special Access Scheme (SAS) B. Such applications must be reviewed and approved by TGA before a suspended product may be supplied to a patient. In granting approval, the TGA must consider the risks and benefits of the device proposed, and why a device currently included in the ARTG cannot be used for the treatment of the individual patient.

Given the reasons for the ARTG suspension, including that the claimed benefits of the highly textured surface of the device was not supported by the manufacturer’s evidence, it is hard to understand why SAS B approval was given, especially when the applications were for cosmetic breast augmentation, not breast reconstruction. In my opinion, these decisions undermine the credibility of the TGA.

The TGA has published, “Information for consumers: What you need to know about unapproved breast implants”. I am concerned that this document hands responsibility for what should be a regulatory decision to an ill-informed consumer in a power imbalance with her surgeon (who may have undisclosed conflicts of interest with the device sponsor).

There is a discrepancy between disclosure of remuneration by prescription medicine companies to Australian doctors compared with medical device companies. The former, stimulated by the ACCC who authorise Medicines Australia Code of Conduct, transparently publish such remuneration; the latter do not! In the USA transparency of payments to doctors by all therapeutic goods companies is mandated by law, in Australia it is not.

I have written to Health Minister Hunt requesting he initiates a Ministerial review of the decision by the TGA to give SAS B approval to use suspended breast implants for 36 patients following applications from six surgeons.

I have also requested he makes disclosure of remuneration to medical practitioners uniform for all manufacturers of therapeutic goods by including this provision as a condition of product listing / registration / inclusion on the ARTG.

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TGA Consultation: Proposed clarification that certain sports supplements are therapeutic goods

See: https://www.tga.gov.au/consultation/consultation-proposed-clarification-certain-sports-supplements-are-therapeutic-goods .

In Australia, food and medicines are regulated under separate legislated frameworks commensurate with their intended use and the potential risks they pose to public health and safety. Whether a product for oral consumption is a food or a medicine in law can depend on its specific combination of ingredients, claims and overall presentation.

Sports supplements often carry explicit or implied claims relating to sport, fitness or recreational performance that mean they are likely to be consumed for therapeutic use, yet some of them may be considered to be food under law. Yet it is appropriate that those sports supplements that are taken to be for therapeutic use are subject to the same national system of controls that are established for other therapeutic goods.

The TGA is seeking comments from interested parties on a proposed approach to resolve some of the uncertainty around the regulatory status of sports supplements, to ensure they are regulated appropriately to safeguard public health and safety.

The deadline for receipt of submissions is close of business, Tuesday 3 December 2019.

Typical complaints:

https://crampfix.com.au/
https://www.facebook.com/EVOSUPPS/posts/evo-labs-kongone-of-our-best-sellers-kong-back-in-stock-selling-out-fast-get-you/2111690962197095/

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Eligibility for Country of Origin Claims in the Complementary Medicines Sector – RIS Consultation

For background see: https://www.medreach.com.au/made-in-australia-complementary-medicine-taskforce-established-foi-report-outcome/

For the Regulatory Impact Statement Consultation Report. Eligibility for Country of Origin claims in the Complementary Medicines Sector. Department of Industry, Innovation and Science. See: https://consult.industry.gov.au/cool-taskforce/clarifying-eligibility-for-origin-claims/supporting_documents/EligibilityfororiginclaimsintheComplementaryMedicineSectorRIS.PDF

The options suggested:

I support option 3c.

Pros:

  • Consumers would benefit from an easily identifiable visual representation of the proportion of imported ingredients.
  • Consumers would be informed of the proportion of ingredients that are imported.
  • Consumers are already familiar with the combination of AMAG logo and ingredient proportion bar chart from food labelling, so replicating that style on complementary medicines would require little adjustment from consumers.

Cons:

  • Manufactures may not want to provide information on the label that ingredients are imported.
  • More information on the label may be a cost to manufacturers.
  • Cost to manufacturers to track proportion of imported ingredients and adjust labelling as required.
  • Manufacturers may see the bar charts a detriment to their marketing efforts.

Conclusion:

Benefits to consumers should be prioritised over minor problems to manufacturers.

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TGA Therapeutic Goods Advertising Compliance 2018-19 Annual Report: Comments

@TGAgovau

On 1 July 2018, the TGA became the sole advertising complaints handling body as a result of recommendations from the Medicine and Medical Devices Regulation Review (MMDR). The inaugural 2018-19 report on the TGA’s work as the sole advertising complaints handling body is now available: https://www.tga.gov.au/publication/therapeutic-goods-advertising-compliance-2018-19-annual-report. See also:

Some examples of unresolved complaints

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Therapeutic Goods Advertising Consultative Council meeting 17 October 2018

Off to Canberra to present, “An evaluation of the first 12 months of the TGA’s new advertising system” on behalf of Choice.

The research was performed by Monash University Research and “Whack-a-mole” students.

Monash Whack-a-mole project
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Surf Coast Spring Skepticamp VII – 14 September 2019

My presentation, “Shayna Jack, sports supplements and regulators” may be of interest.

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Australian Pharmacies sell contaminated CAMs; TGA regulation ratshit!

Recent Australian research has found nearly 50% of CAM products tested had contamination issues, with some showing the presence of animal ingredients, nuts, wheat, pharmaceuticals and toxins: See:

This is yet another example of the failure of the TGA’s trust-based regulatory system for listed products that has no pre-market evaluation and trusts sponsors to obey the rules. This research amplifies the TGA’s own limited findings on post-market surveillance, their recent consumer survey and the high level of upheld advertising complaints.

No wonder the industry is resisting publication of the names of companies and products failing TGA post-marketing surveillance!

It’s time the Australian National Audit Office (ANAO) repeated their 2011 audit to examine the effectiveness of the TGA’s administration of complementary medicines regulation.

Too many problems have continued for too long and consumer detriment is the result.

Postscript 06/09/2019:

From Pharmacy Daily 06/09/2019

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‘Reprehensible’ prescribing to vulnerable patients

MWI complaint submitted and publicised 23 June 2016; legal threats rebutted by Maurice Blackburne Lawyers pro bono, won 2016 Choice Shonky award, three years later we finally have an outcome.

“A medical practitioner has been found guilty of professional misconduct after prescribing compounded phentermine, diethylpropion and hCG to assist patients with weight loss.

Drugs prescribed by MWI

See also:

Good to see that legal wheels turned for Dr Goyer, albeit slowly! But what about the compounding pharmacist who was also involved?

https://acpharm.com.au/

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More complaints to TGA about illegal body building and weight loss supplements

The TGA recently had a $10 million fine awarded by the Federal Court against Peptide Clincs Pty Ltd for breaches of advertising regulations, including advertising prescription-only medicines to the public. However, the company involved had gone into liquidation some months earlier and will not pay. In its media release the TGA said,

Please report non-compliant advertisements to the TGA, such as those promoting unapproved therapeutic goods that claim to be image enhancing. The TGA will investigate and take action.

Indeed, similar complaints have been submitted some time ago, but still lack a published outcome. For example, Evolution Supplements King Kong stack

https://evolutionsupplements.com.au/evo-labs-kong-60-capsules/

More recently, complaints have been submitted about Muscle Peptides Australia and Peptides Direct Australia & NZ (some products promoted below).

So, there is plenty of examples to exercise the TGA’s new compliance and enforcement powers. Hopefully, before more companies go into liquidation!

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