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Flood of unsubstantiated claims prompts change to therapeutic goods regulation

04/04/2018By Matthew Woodley
Changes designed to strengthen the Therapeutic Goods Administration (TGA) and its advertising code are due to come into force on July 1, however, some experts are concerned about aspects of the new amendments.

The alterations will be felt across the entire spectrum of Australia’s therapeutic goods industry, but the largest target is the complementary medicines sector – the members of which have been found to regularly make false or misleading advertisements, including various companies that produce vitamins they claim promote ‘eye health’.

The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 will include higher penalties for companies caught breaking the rules, a new advertising code, increased post marketing surveillance, and the scrapping of the complaints resolution panel (CRP) in favour of a more transparent process. However, despite a positive response to many of these changes, the removal of the pre-approval process for some advertisements has consumer advocates concerned about a move towards self-regulation for an industry that to date has consistently failed to uphold legislated standards.

‘Traditional evidence’

The current pre-approval process annually reviews more than 2,000 advertisements, most of which require changes to avoid code breaches, and in some cases TGA Council member Dr Ken Harvey wholesale revisions. Controversy has also swirled around the creation of a list of ‘permitted indications’, which is designed to limit the language that can be used to promote supplementary medicines, but has been criticised for allowing the use of indications supported by ‘traditional evidence’.

Such an allowance has seen much of the list now include claims of supplementary medicine that “tonifies kidney essence” or “replenishes the gate of vitality”. Dr Ken Harvey, a Therapeutic Goods Advisory Council member who has frequently criticised Australia’s health regulator, said while he is supportive of most the changes, he is hopeful some amendments will be made before the bill comes into effect.

“Currently, 86% of indications on the list submitted by industry and endorsed by the TGA can now be supported with traditional evidence. That means you can say ‘saffron’s been used traditionally for eye health’, which it has, but does it work? No,” Harvey said.

“You can say 'saffron's been used traditionally for eye health', which it has, but does it work? No.”
Ken Harvey, TGA Council member

“Although the list has been published, it hasn’t been granted parliamentary approval and it is a list that could be challenged in Parliament.”

Additionally, Harvey believes potential conflicts of interest still exist within the TGA, as it is funded almost entirely by industry, while he also cited a lack of resources and transparency as other ongoing problems that weren’t properly addressed by the legislation.

“The TGA currently has the unenviable reputation as a black hole with respect to informing complainants, and the public, about the outcome of complaints,” Harvey said.

“Since 2011 the CRP noted that 541 complaints have been submitted to the TGA for non-compliance with panel determinations and other reasons. To date, the TGA has only published information about 78 (14%) complaints. Numerous additional complaints, sent direct to the TGA, have never been reported upon.”

“Hopefully, their performance with respect to transparency will improve in the new system,” Harvey added.

The TGA has previously vehemently denied conflicts on interest related to its funding system, and in an interview with Fairfax late last year a spokesperson rejected charges it was too close to the industry: “This system has been in place for more than 20 years and there has been no evidence of any sort of ‘regulatory capture’.

“Other medicines and device regulators internationally also are fully or significantly funded by industry fees and charges, and operate in the same way. This takes the burden off the taxpayer for such time- consuming scrutiny.”

Ophthalmic sector

One supplier that is looking forward to the changes, despite being sanctioned late last year, is the manufacturer of the Macutec eye health vitamins, Stiltec. The company was forced to place a retraction on its website and social media pages for 90 days recently after one of its overseas employees, unaware of Australian regulation, linked materials intended for an international market to Macutec’s website, Facebook and Twitter pages.

Designs for Vision

Stiltec director Mr Steven Mann said while he accepted the company had made a mistake, the drawn-out process had meant the business was still dealing with the fallout more than six months after the offending material had been removed.

“I don’t think the so-called Complaints Resolution Panel has been particularly efficient in dealing with these things. There’s no scope for appeal without going to the TGA, and they’ve been very, very slow.”
Steven Mann, Stiltec director

“I don’t think the so-called Complaints Resolution Panel has been particularly efficient in dealing with these things. There’s no scope for appeal without going to the TGA, and they’ve been very, very slow,” Mann said.

He added that a move toward self- regulation would not affect the way Stiltec promoted its product, but that the reduction in red tape would help save costs. Mann also said the increased fines should be enough of a deterrent to prevent the majority of sponsors from producing inappropriate advertising content.

“I don’t think anyone has anything to fear should they be vigilant in terms of what they say. We’re not big advertisers to consumers. We have our website where people can order directly from us, but most of our target audience are ophthalmologists and optometrists,” Mann said.

“We don’t promote our products directly to consumers, so that their eyecare is managed in the most professional way specific to individual patients needs.”

However, despite Mann’s confidence in the majority of the therapeutic industry, other companies that market directly to consumers draw the ire of the TGA on a regular basis – including within the eye health sector. Insight discovered a number of CRP determinations against MDEyes, Blackmores (twice), HealthOne, and Bioglan for illegal claims associated with vision products within the past five years alone.

Tip of the iceberg

Yet, that may not even scratch the surface in terms of the number of companies flouting the rules because, while there are around 11,000 complimentary medicines currently on the Australian Register of Therapeutic Goods (ARTG), the TGA only conducted post-marketing tests on 417 products last year. Of those, 79% were found to be in breach of the code, while sponsors cancelled a further 74 following a request for information from the TGA.

Westmead Hospital retinal surgeon Associate Professor Adrian Fung told Insight he is concerned many vitamins and supplements marketed as supporting eye health are based on unsubstantiated claims.

“Currently there are several products sold on the Australian market which purport to target a particular demographic, such as children, to protect them from ‘blue light’ from digital devices, or assist with ‘eye strain’. Many of these claims are misleading and have little or no evidence-based medicine supporting their assertions,” Fung said.

“Not only are they often unnecessary and costly, they can give a false sense of security to patients and in some cases may even be harmful.”

However, despite the appetite for change among consumer advocates, the medical profession, and some lawmakers, the amount of money involved in the supplementary medicines market means there is also pushback from groups that want to protect the $4.5 billion industry.

Harvey is cautiously optimistic the new legislation will be an improvement, but after calling for change for more than 15 years he is also wary of how vitamin companies are able to find ways to circumvent the system.

“My cynical prediction would be we’re going to see an awful lot more ‘traditional claims’ for eye health,” he said.

“Will the industry be cleaned up? That’s the $4 billion question.”

AFT Pharmaceuticals

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