Launch of TGA Advertising Hub – Initial experience of submitting complaints

The TGA Advertising hub still notes:

“We are experiencing intermittent IT issues that are impacting this form. If you experience an error lodging a complaint, please try again later. We are working to fix this issue as a matter of priority”.

Regardless, I’ve now been able to submit six complaints that I’ve suggested are high priority.

They are all based on previous complaints upheld by the CRP but whose sponsor (and others) continue to make claims that were determined to breach the Therapeutic Goods Advertising Code.

  1. Complaint to TGA: Pharmacare Laboratories Ease-a-cold products, 5 July 2018, AL-B81GN1V3/2018
  2. Complaint to TGA: Pharmacare Laboratories Promensil Menopause products, 6 July 2018, AC-4I7BPN1V/2018.
  3. Complaint to TGA: Pharmacare Laboratories FatBlaster FatMagnet products, 6 July 2018, AC-GBKDH2XG/2018
  4. Complaint to TGA: Pharmacare Laboratories Nature’s Way Magnesium Products, 7 July 2018, AC-GOZU449N/2018
  5. Complaint to TGA: Pharmacare Laboratories Sambucol Products, 9 July 2018, AC-FR55H9ST/2018
  6. Complaint to TGA: Weleda Arnica Homeopathic Products, 10 July 2018, AC-I9WC23OP/2018got

There are now a few complaint “outcomes” appearing on the TGA web site . All have assessed by the TGA as “low priority” and the outcome” is merely a ‘Compliance notice sent with educational material”.

There are no details of the complaint, product or sponsor that would enable one to check the priority assigned, let alone see if the “notice” actually achieved compliance!  As predicted, very convenient for the sponsor and the TGA .

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TGA’s new complaint system fails the Ease-a-cold test; Outcomes of Advertising Complaints Investigations Specification 2018 enacted

Stimulated by an article in today’s “The Conversation” on Pharmacare Laboratories Ease-a-Cold (below), I decided to try the TGA’s new complaint system.As I mentioned in a comment on this article, this product has been the subject of a previous article in “The Conversation” in 2015: https://theconversation.com/dont-believe-the-hype-your-complementary-medicines-are-unlikely-to-deliver-52139.

It has also had six upheld complaints by the now abolished Therapeutic Goods Advertising Complaint Resolution Panel (CRP) from 2005 to 2016 and a recommendation to the Secretary from the CRP in 2017 for failure to withdraw misleading representations that the product had “been ‘clinically trialed’ in the sense of being demonstrated to have effects such as reducing the duration, impact on daily life, or severity of symptoms of a cold”. Typically, I could find no outcome of this recommendation to the Secretary (TGA) on the TGA web site.

In addition, there was a decision to withdraw advertising approval (in specified media only, not the internet) by the TGA on 11 Oct 2017, see: https://tga.gov.au/decision-withdraw-medicines-advertising-approval.

Regardless, this product continues to be advertised with claims that have been repeatedly judged to be misleading and deceptive.

Furthermore, Pharmacare Laboratories has the unenviable reputation of the having the most upheld complaints of any sponsor of complementary medicines over the 10-year life of the CRP.

However, upon submission of the attached complaint I received the following error message:

This is the same error I reported to the TGA when I tested their system on Thursday 17/05/2018. It’s a pity it remained when the system went live.

I submitted that this complaint should be assessed as “high priority” because the sponsor is recalcitrant, the product has had numerous upheld complaints and the varied advertising claims by the sponsor (and many others) continue to state or imply that that the product will shorten the duration and severity of a cold when it will not.

I alleged (repeated) breaches of the Therapeutic Goods Advertising Code 2017, sections 4(1)(b), 4(2)(a) and 4(2)(c). In addition, specific indications on  ARTG Public Summary Documents are equally misleading and deceptive.

I asked for an immediate response from the TGA to me as to the priority allocated to this complaint, and subsequently, the measures taken by the TGA to achieve compliance and the outcome (for publication).

I am concerned that the recently enacted Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2018 only states that,

“The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act….”.

It remains to be seen what we get back from the TGA for the attached test complaint.

 

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TGA Advertising Portal and Complaint System now live; Industry embrace permissible indications

See: https://www.tga.gov.au/advertising-hub and: https://ajp.com.au/news/tga-explains-new-advertising-landscape/

However, there are still concerns about the transparency of the new system and my colleagues and I are holding off submitting complaints until we know:

  1. The outcome of the TGA Consultation: Complaints handling – Advertising therapeutic goods to the public (and publication of the public submissions).
  2. The Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2018 has been enacted (which in theory allows for more transparency of compliant outcomes).

Meanwhile, the Therapeutic Goods (Permissible Indications) Determination No.1 of 2018 came into operation on March 6, 2018 while the Choice campaign to disallow it finally produced a commitment from the Labor Party to address consumer concerns if elected. Disallowance was considered impractical as it would have disrupted new listings of complementary medicines. See also:  http://medicalrepublic.com.au/alp-commits-disclaimers-evidence-free-medicine/1535.

To-date,  there are now around 564 products listed using the new permissible indications determination.

As anticipated, abolishing “free-text” appears to have made little impact given the huge list of industry supplied, TGA endorsed, dubious “permissible” indications. Some examples of the craziness allowed in the ARTG public summaries are:

As anticipated,over 80% of these newly listed products have used the option of invoking “traditional” indications.

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TGA response to criticism of new complaint handling system; my comment

See: https://www.theguardian.com/australia-news/2018/jun/05/consumers-wont-know-about-dodgy-drug-ads-under-new-complaints-system-experts-warn

The TGA media spokesperson said:

“The new system will be more transparent than the previous one, apart from publication of TGA’s performance against key performance indicators detailed information on individual complaints will be published for medium-, serious- and critical-level complaints. Information on numbers and frequency of low-level complaints and on complaint trends will be published in biannual reports”.

However, according to my reading of the TGA complaint handling proposals the TGA will not:

  1. Provide complainants with the priority level their complaint is assigned until they are informed of the “outcome” (appended).
  2. Provide information (compliant determinations) to the complainant (or the public) on whether the Code breaches alleged by the complainant were upheld or not (as the current CRP does).
  3. Routinely evaluate (or publicise) if the regulatory action taken achieves compliance, such as sending “regulatory obligation notices” (for cases judged low priority) or “warning letters” (for medium priority cases).

For the low-priority cases, merely sending a notice closes the case; for medium-priority cases, receipt of “an acceptable response” apparently closes the case.

Indeed, the TGA states that an “acceptable response” is only likely to be checked if the complaint is assessed as critical (page 14 of the consultation document).

Yet, experience with the current CRP shows that many sponsors will assert they will fix the problem, but then don’t, especially for second level advertisers that copy the original advertising material, such as Chemist Warehouse.

Alternatively, sponsors may correct the breaches pointed out, but then create new ones.

Monitoring compliance is essential; trusting advertisers is naive! The current trust-based system has led to an 80% non-compliance figure found when the TGA performs their limited number of post-marketing assessments on complementary medicines.

In short, the “detailed information on individual complaints that will be published for medium-, serious- and critical-level complaints” would appear to be only that a complaint has been received on a certain date, the product involved, the company responsible (for high & critical cases only) and the outcome, “enforcement action taken”.  NOT compliance achieved! 

Screen shots below (07/06/2018) publicly available from:

https://compliance.uat.tga.gov.au/advertising-complaints-outcomes/

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TGA Complaint Handling – Our submission

There was considerable support for the concept of single body taking over the existing Therapeutic Goods Advertising Complaint System to provide a single, more efficient, complaint body, with powers to apply timely and meaningful sanctions for regulatory violations.

The Government then decided that the TGA would assume responsibility for handling all complaints about therapeutic goods advertisements directed to the public from 1 July 2018. This model would be independently reviewed after three years of operation to determine whether it was the most effective solution.

However, the TGA’s proposals for the  implementation of the new Therapeutic Goods Advertising Complaint Handling System leaves a lot to be desired!

Our submission (endorsed by Friends of Science in Medicine) notes that the TGA’s new system will be much less transparent than the current Complaint Resolution Panel; very convenient for both the TGA and Industry, but not for consumers or complainants.

We also reiterate the point made in other submissions; unless the TGA accepts that consumer protection is an equal objective to industry assistance, and gains the will to act, a revised Code and complaint system (including increased penalties and sanctions) will have no more impact than the current dysfunctional system.

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Choice takes campaign to disallow the Permissible Indications Determination to Canberra

Katinka Day, Choice Campaigns and Policy Team Lead, delivers mock-ups of shonky products allowed by the TGA’s permissible indications determination to Senators, see:

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Campaign to disallow the Therapeutic Goods (Permissible Indications) Determination No.1 of 2018

The Therapeutic Goods (Permissible Indications) Determination No.1 of 2018 is currently on the Senate Disallowable Instruments List until 25 June 2018.

Friends of Science in Medicine (FSM) have joined Choice (the Australian Consumers’ Association) and other civil society organisations to petition Senators to disallow this determination.

A letter requesting disallowance has been sent to Labor, Greens and Independent Senators by FSM.

This is because the Government and the Department of Health have taken no notice of previously expressed concerns about this determination, for example:

The commendable aim of this determination was to stop sponsors of complementary medicines from making creative free-text indications that were then used to make misleading and deceptive advertising claims that lacked an evidence base.

However, the TGA allowed industry to formulate the list of permissible indications with the result that 86% of 1019 indications can now be supported by “traditional” evidence from belief-based alternative medical systems such as Homoeopathy, Traditional Chinese Medicine, Ayurveda Medicine and Western herbalism.

An inevitable perverse outcome of this determination will be that sponsors of complementary medicines will change the indications of many of their products from “scientific” to “traditional” to the detriment of public health, as illustrated in a classic ABC Checkout program. Why else would industry have produced such a list?

Australia is a multicultural and pluralistic society and it is appropriate we allow access to alternative medical traditions and products. There is also understandable national pride in Traditional Chinese Medicine (TCM), Ayurveda and other indigenous medicines. In addition, valuable knowledge can be found in such traditions. For example, the 2015 Nobel Prize award for medicine was awarded to a Chinese researcher for extracting an anti-malarial drug from the herb (Artemesia annua) mentioned as a treatment for fever in a 4th Century CE text of Traditional Chinese Medicine.

However, as Nobel committee member Hans Forssberg noted, “It’s very important that we are not giving a prize to traditional medicine, the award was only for scientific work that had been inspired by it.”

Traditional medicines are by default prescientific, and thus is not surprising that the theories on which such traditions are based have not been validated by scientific inquiry. These include the centuries old TCM concept of meridians through which the life-energy known as ‘qi’ flows, the Ayurveda concept of life-forces (dosha) and body types (vata, pitta and kapha) and the more recent homeopathic concept that ‘likes cure like’.

While the TGA appears to give equal validly to “traditional” and “scientific” evidence, this is not in keeping with modern scientific understanding as documented in the NHMRC’s levels of evidence which puts “traditional” knowledge on the bottom rung (below).

It is also not in keeping with the objects of the Therapeutic Goods Act 1989 which include providing for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods (my emphasis). Traditional use provides no evidence of efficacy nor does it guarantee quality or safety.

We believe it is important to ensure that consumers understand the difference between “traditional” and “scientific” evidence. We also need to restrain the increasing mass marketing of traditional medicines from taking advantage of consumer ignorance and we need to protect consumers from misleading and deceptive claims about such products.

Accordingly, FSM and others have advocated that an advisory like the following be added to the pack and promotional material of all products invoking a traditional paradigm:

“This product is based on traditional beliefs and not modern scientific evidence”.

In the Senate debate on the Therapeutic Goods Amendment (2017 Measures No. 1) Bill, Senator McKenzie (presumably advised by the TGA) said,

“The evidence from the United States, where the US Food and Drug Administration has mandated such disclaimers, is that these disclaimers are ineffective in assisting consumers to make more informed choices when self-selecting medicines”.

Our own review of the literature shows that the evidence about disclaimers and advisories is much more nuanced that what Senator McKenzie stated.

In our opinion, the TGA has misled Parliament by failing to provide a balanced account of the evidence about advisories and disclaimers.

For example,

  1. The 1994 U.S. Dietary Supplement Health and Education Act (DSHEA) disclaimer is very different to what has been proposed in Australia. It reads,“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease”.
  2. Dodge et al., 2011 showed that addressing deficits in individuals’ knowledge about the DSHEA influenced beliefs about dietary supplements. Specifically, educating individuals about the DSHEA made them more skeptical of the safety and effectiveness of dietary supplements.
  3. The U.S. Federal Trade Commission (FTC) acts against dietary supplement companies for product promotions that violate the Federal Trade Commission Act. In November 2017 they produced an advisory similar to what was requested in Australia for one category of traditional medicines, homeopathic products.
  4. More recently, the U.S. FDA have also proposed a new, risk-based enforcement approach to drug products labelled as homeopathic.
  5. Health Canada has now included an advisory on homeopathic products targeting children’s complaints, like what Australian consumer and health professional organisations recommended (Figure 1, below). If Health Canada can do it why not the TGA?
  6. Finally, although the TGA has stated disclaimers and advisories don’t work, they have nevertheless required advisory statements for some traditions in their Permitted Indications determination and the draft Code, for example:

“Seek advice from a registered Chinese medicine practitioner or Ayurvedic medicine practitioner to ensure this medicine is right for you”.

The TGA have alleged that other belief-based traditions, such as Homeopathy, are better understood but that is not our experience in discussing TGA regulation with consumers.

Some politicians have said that they support the Permissible Indication determination because it is an improvement on what has gone before. We disagree. As pointed out above, we believe it will create a flood of products with “traditional” indications and claims that will confuse and mislead consumers. More importantly, these products have the potential to cause consumers to forgo more evidence-based treatment to the detriment of their health.

We ask you to support the campaign to disallow the Therapeutic Goods (Permissible Indications) Determination No 1 of 2018 so that educational advisories can be made mandatory. Please write to your Senator.

The Determination will expire from the Senate Disallowable Instruments List on 25 June 2018.

Figure 1. Advisory required on traditional homeopathic products by Health Canada

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TGA Consultation: Complaint handling and monitoring

Yet another TGA consultation; this one closing on 4 June 2018 for a new regulatory system that is meant to start on 1 July 2018! For the last one on the draft new Therapeutic Goods Advertising Code, see my comments here.

There are a number of concerns with the TGA proposal on their new complaint system (updated on 10/05/2018 after response from TGA):

Transparency:

A complainant who sends a valid complaint will receive an email with a case identification number. However, unlike the existing CRP system, it appears that the complainant:

  • Will NOT receive a detailed determination as to whether their allegations of specific Code breaches were agreed with or not (unlike what the CRP currently publishes),
  • Will NOT be told the priority level their complaint has been assigned to,
  • For a case the TGA regards as low priority, they may find some information about their complaint in bi-annually statistics the TGA propose to publish on the number, frequency and nature of complaints dealt with.
  • For cases the TGA regards as higher priority, it is said that complainants will be notified of a brief outcome posted on the TGA web site.

Low priority cases, the only details published appear to be the case identification number, date received, date completed and the outcome; that is, a “regulatory obligation notice” was sent. There apparently will be NO information published on:

  • The product involved;
  • What alleged Code breaches were determined by the TGA to be justified?
  • If the “notice” achieved compliance (the TGA says some target reviews may be done on such cases)?

Why should the complainant have to follow up if compliance has been achieved; why not the TGA in all cases?

Medium priority cases, where an acceptable response is received to a warning letter (which appears to be merely a statement from the sponsor that the alleged breach has been responded to), the details of the responsible entity along with the case identification number, date received, date completed, the therapeutic goods involved, compliance action/s taken (or proposed) and the outcome will be published. Once again, NO information is provided on:

  • The product involved;
  • What alleged Code breaches were determined by the TGA to be justified?
  • Whether the “response” achieved compliance or not?

Experience with the current CRP shows that many sponsors will assert they will fix the problem, but then don’t; alternatively, they may correct the breaches pointed out, but then create new ones!  In short, monitoring is essential; trusting sponsors is naive!

High priority and critical priority cases, a determination will be made as to the most appropriate regulatory tools to be used. Where these matters are resolved, the details of the responsible entity, the case identification number, date received, date completed, the therapeutic goods involved, the compliance action/s taken, and the outcome will be published.

It appears that these are the only cases in which the product involved may be identified. But apparently not if compliance is achieved by negotiation rather than administrative or regulatory action, such as cancellation or suspension of therapeutic goods from the ARTG, enforceable undertakings, infringement, directions and public warning notices, and court outcomes. Not good enough!

In conclusion, the proposed TGA complaint system provides much less transparency that the current CRP system; very convenient for industry and for the TGA!

Monitoring and trend analysis

There is considerable concern about the TGA’s ability to perform this task. My colleagues and I have previously asked that TGA post-marketing compliance data be broken down into targeted and random reviews. This breakdown is NOT found in the TGA’s annual performance statistics and half yearly performance snapshots.

Rather the TGA lumps data on compliance breaches for both targeted and random reviews together. This means that if the TGA targets a category of product (such as sunscreens) which have less compliance breaches than other categories (such as herbal or homeopathic products), then the overall compliance rate appears to improve as the latest TGA snapshot showed. This was reported by the media as, “Complementary Medicine Compliance Improves (80% non-compliance drops to 56%)”. TGA targets need to be reported publicly, not merely made available for industry to selectively report.

The latest data provided, “Listing Compliance Reviews FY2016-17” (attached) has the following problems:

  • It gives percentages but not absolute numbers. Good reporting practice means all percentages presented should be preceded by the numbers they represent.
  • It has added a new column to the table, Project” which is not present in the “Annual performance statistics report: July 2016 to June 2017 3.3.2 Compliance reviews”. What does this mean? If it’s projects mentioned in the annual report that targeted oral probiotics indicated for vaginal conditions and listed medicines with blood glucose and cholesterol indications, what other investigations comprise the “targeted” column?

It is also important to break down the results for the main categories of products targeted by random reviews: e.g. Vitamins and minerals, Fish oil, Western Herbal Medicine, Chinese Traditional medicine, Ayurveda (Indian) medicines, Homeopathic Medicines, Probiotics, Sunscreens and Aromatherapy products.

Finally, it’s crucial to report to consumers and health professionals the most non-compliant companies. This will help consumers to select products and health professionals to give advice. It will also provide a stimulus for the named companies to improve.

In the second Civil Society Seminar on, “The Advertising of Therapeutic Goods and Services (and its regulation)” held at Monash law Chambers on Sept 8, 2017, and attended by the TGA’s now departed Ross Hawkins, we heard a presentation by Suzanne Crowle, Director of Engagement and Complaints, of NSW Fair Trading.

The NSW Fair Trading Complaints Register provides information about businesses that are the subject of 10 or more complaints received by Fair Trading in a calendar month. It’s updated monthly and only includes complaints considered by Fair Trading to have been made by a real person, relating to a real interaction with a business. It provides information about the name of the business; the number of complaints NSW Fair Trading has received about the business in the last month and the product groups complained about.

If NSW Fair Trading can do this monthly, why can’t the TGA do it at least 6-monthly?

Finally, I reiterate the point made in other submissions; unless the TGA accepts that consumer protection is an equal objective to industry assistance, and gains the will to act, a revised Code and complaint system (including increased penalties and sanctions) will have no more impact than the current dysfunctional system.

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TGA Consultation: Draft therapeutic goods advertising code 2018 #2

For background, see TGA Consultation: Draft therapeutic goods advertising code 2018 #1

Our full submission is available here. It’s endorsed by Friends of Science in Medicine (FSM) and the writing was assisted by two Monash University students, Malcolm Vickers (MPH) and Alanna Rottler (BMedSci (Honors).

The submission points out that many suggestions put forward by civil society in previous consultations to the TGA, the Senate Inquiry into the Therapeutic Goods Amendment Bill (2017 Measures No. 1) Bill 2017, a Civil Society Public Forum held at the Australian National University, media articles and TGA stakeholder consultations have been ignored.

We note that the TGA appears to give equal validly to ‘traditional’ and ‘scientific’ evidence, which is not in keeping with modern scientific understanding as documented in the NHMRC’s levels of evidence. Traditional evidence (opinion) occupies the lowest level of the hierarchy of evidence. See below.

We also point out that ‘traditional’ medicines can be both ineffective and dangerous and their increasing mass marketing often includes misleading and deceptive claims which takes advantage of consumer ignorance.

Given our multicultural and pluralistic society, we accept that it’s appropriate for Australians to have access alternative medical traditions and products. There is also considerable national pride in Traditional Chinese Medicine (TCM), Ayurveda and Unani and valuable knowledge can be found in such traditions.

However, many of the theories on which such traditions are based have not been validated by scientific inquiry, such as the TCM concept of meridians through which the life-energy known as ‘qi’ flows, the Ayurveda concept of life-forces (dosha) and body types (vata, pitta and kapha), and the homeopathic principle of ‘like cures like’. In addition, traditional medicines can be both ineffective and dangerous.

We argue that it is important to ensure that consumers understand the difference between “traditional” and “scientific” evidence. We also need to restrain the increasing mass marketing of traditional medicines from taking advantage of consumer ignorance and we need to protect consumers from misleading and deceptive claims about such products.

In appendix I, III and IV of our submission we have listed many products invoking traditional paradigms that make claims we allege are misleading and deceptive.

We reiterate, a likely perverse outcome of the Permitted Indication policy will be that sponsors of complementary medicines will change the indications of many of their products from “scientific” to “traditional” and increasingly introduce the latter, to the detriment of public health.

Among many other changes needed to the draft Code:

  • All claims invoking traditional paradigms must be accompanied by an advisory statement such as, “The claims for this product are based on traditional beliefs and not modern scientific evidence”.
  • If there is conflicting evidence between the history of traditional use and contemporary scientific evidence for your medicine, all labeling and advertising material must state: “This traditional use is not supported by scientific evidence”.
  • If there is both a history of traditional use and contemporary scientific evidence supporting the claims made then the above advisories need not apply.

There is dispute about the impact of advisories, yet the TGA has mandated several without research on whether consumers understand or will act on statements such as:

  • “St John’s Wort affects the way many prescription medicines work – including oral contraceptives. Consult your doctor.”
  • “Please seek the advice of a traditional Chinese medicine practitioner or Ayurvedic medicine practitioner to ensure this medicine is right for you”.

Research is required on whether TGA advisories and others suggested will achieve the desired objective. This is now underway at Monash University.

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TGA Consultation: Draft therapeutic goods advertising code 2018 #1

The TGA is seeking comments from interested parties on the proposed draft Therapeutic Goods Advertising Code 2018 (the Code) and associated guidance document. Comments should be submitted to the TGA by COB Friday 27 April.

Typically, many suggestions to improve the Code made by non-industry stakeholders in numerous previous consultations have been ignored.

The TGA’s strategy is to overwhelm stakeholders with numerous consultations in the hope of inducing confusion and submission fatigue. Then they tell Parliament they have extensively consulted stakeholders, but not that they have taken no notice of non-industry submissions!

For example, the Explanatory statement of the Therapeutic Goods (Permissible Indications) Determination No.1 of 2018 states,

“The draft list of indications was then published on the TGA website for public comment between July and October 2017. 110 submissions were received during that period from consumers (12 submissions) and industry stakeholders (98 submissions). Industry submissions primarily proposed additional indications for inclusion in the instrument, while consumer submissions expressed concerns about the terminology and evidence base for ‘traditional indications’ and contended that the number of indications in the instrument should be reduced. Stakeholder comments were considered, and the instrument was further refined to incorporate some improvements for greater clarity and in order to ensure that the list of indications is comprehensive and commensurate with the low risk nature of listed medicines”.

This contains nothing about numerous submissions from the RACGP, ASCEPT and others that argued that if consumers were to make an informed decision on ‘traditional” medicines an advisory statement was required along the lines of

“This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts” &/or “No scientific evidence has been provided that this product works”.

It did not mention public concern voiced by the RACGP President, “Alarming health claims must not appear on complementary medicine” and others, such as “New list of permitted advertising lines for complementary medicine products does little to protect consumers”.

Non-industry stakeholders have two remaining strategies to stop this craziness:

  1. Insist that the above advisories and other matters be added to the draft Therapeutic Goods Advertising Code 2018 (see notes).
  2. Write to Senators supporting the CHOICE campaign to disallow the Therapeutic Goods (Permissible Indications) Determination until health professional and consumer concerns are considered (See Choice letter).

 

 

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