TGA Consultation: The regulatory framework for advertising therapeutic goods

Information about this consultation is available here.

A submission by my students (Sasha Hall and Tiana Moutafis) and myself is now available.  This may be of interest to people writing their own.

See also: Australia’s regulation of complementary medicines claims is badly flawed.

And: Dodgy claims for complementary medicines? Here’s how the drug watchdog could have more bite

N.B. Submissions closes on 21 December 2016.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
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4 Responses to TGA Consultation: The regulatory framework for advertising therapeutic goods

  1. Frank Lister says:

    Dear Prof Harvey, A 2016 TGA ruling against a transdermal magnesium oil supplier to publish a retraction in response to one of your students complaints has been ignored. Is the TGA a toothless tiger? What should happen if the supplier simply ignores the TGA’s ruling to publish a retraction? Whats the point of filing TGA complaints if rulings are simply ignored and unsubstaintated health claims continue to be made?

    Your quest for evidence based medicine is heroic and well overdue.
    How can we support these endeavours?

    • Dear Frank, I presume you are refering to complaint 2015/08/009 http://www.tgacrp.com.au/complaint-register/?_search=2015/08/009

      Currently around 40% of rulings of the TGACRP are ignored because the Panel has no power to enforce its determination. Non-compliance is referred to the Secretary of the Department of Health who also lack the power to effectively deal with non-compliance.

      So yes, the current system is a toothless tiger!

      But considerable pressure has been brought to bear to fix these problem and there is some movement in this regard: See:
      https://theconversation.com/dodgy-claims-for-complementary-medicines-heres-how-the-drug-watchdog-could-have-more-bite-69488

      See also another article in “The Conversation” to be published tomorrow afternoon, “Which supplements work? New labels to help separate the wheat from the chaff”.

      How to support fixing the system? Write to the latest Health Minister via your local member of parliament supporting the current proposals for regulatory reform (which of course are opposed by industry).

      • Frank Lister says:

        Dear Prof Harvey, thank you for your reply.

        My local member is Julie Bishop and I will definitely write to her regarding these issues.
        The complaint was against Amazing Oils as you pointed out.

        Amazing Oils are currently claiming that they have an organic source of magnesium chloride flakes from a pristine lake somewhere in Australia. We have not been able to locate ANY producers of magnesium chloride flakes in Australia.
        https://www.amazingoils.com.au/products/magnesium-bath-flakes

        All their health claims for magnesium are based upon 3-4 pilot studies

        http://cnelm.com/NutritionPractitioner/Issues/Issue_11_1/Articles/7%20Transdermal%20Mg%20revised2.pdf

        http://www.mgwater.com/transdermal.shtml

        This method of Mg delivery was ‘discovered’ by a Dr Sircus in 2005 and promoted by Dr Carolyn Dean and Dr Norm Shealy. Based upon these pilot studies they have developed an international, multimillion dollar industry and potentially changed the delivery method of magnesium supplementation from oral to transdermal.

        I have chronicled the emergence of this transdermal magnesium meme leading to its arrival in Australia in 2009 with Amazing Oils.

        Can the TGA be asked to examine the evidence being held in support of their transdermal claims?

        Rgds

        Frank

        • Dear Frank,

          Yes, the TGA can be asked to perform a post-marketing review on this product which could lead to de-listing (albeit this usually only results in the company re-listing the product under another name (yet another flaw in the current regulatory system)! Meanwhile, there is another complaint for this product (by my students) in the TGACRP pipeline (slow to progress as the TGACRP is overloaded and under-resourced).

          I suggest you write to the TGACRP cc to TGA (below) noting your concerns and asking for a TGA post-marketing review to be urgently performed.

          Judith Brimer
          Executive Officer
          Complaints Resolution Panel
          Level 13, Macquarie House
          167 Macquarie Street, Sydney NSW 2000
          Tel: 02 8667 3025
          Judith Brimer jbrimer@tgacc.com.au

          cc

          Adjunct Prof John Skerritt FTSE FIPAA (Vic)
          Deputy Secretary for Health Products Regulation
          Department of Health
          PO Box 100 Woden ACT 2606 Australia
          Phone: (02) 6232 8200 Fax: (02) 6203 1265
          Email: John.Skerritt@tga.gov.au

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