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RACGP flags reservations regarding TGA amendment bills


Paul Hayes


16/01/2018 12:00:47 PM

The RACGP is concerned that a Therapeutic Goods Administration list of permitted indications includes numerous ‘traditional’ indications that encourage the pharmaceutical industry to evade products’ scientific proof of efficacy, endorse pseudoscience, and will mislead and confuse consumers.

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President Dr Bastian Seidel said the RACGP’s default position would be to restrict therapeutic claims to those supported by robust scientific evidence.

The RACGP last week made a submission to the Senate Community Affairs Legislation Committee regarding the inquiry into the Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017.
 
Under these bills, the Therapeutic Goods Administration (TGA) will introduce a list of permitted indications from which sponsors must exclusively draw when listing their medicine on the Australian Register of Therapeutic Goods (ARTG). The list of indications is designed to:

  • ensure that listed medicines can only make low-level indications that are suitable for medicines that do not undergo pre market assessment
  • provide transparency for sponsors on what indications are suitable for listed medicines to help prevent inadvertent non-compliance.
Given its concerns about the traditional indications on the list, the RACGP has asked the Senate Community Affairs Legislation Committee to recommend the:
  • TGA create a mandatory obligation that all products relying on tradition-based health claims must be accompanied by a statement that there is no good scientific evidence to justify that health claim
  • range of goods covered by the Therapeutic Goods Advertising Code be broadened to include other products, including foods.
‘The RACGP preferred “default” position would be to restrict therapeutic claims to those supported by robust scientific evidence,’ RACGP President Dr Bastian Seidel said in the submission. ‘However, we are aware that such a regulatory outcome is unlikely, and that the vast majority of indications that have been proposed by industry – 879 out of 1019 – fail to meet this criterion.
 
‘We therefore propose instead that a “lack-of-evidence disclaimer” must immediately follow any unsupported health claim.’
 
For example: ‘This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works’.

The full submission is available on the RACGP website.



Australian-Register-of-Therapeutic-Goods Therapeutic-Goods-Administration Therapeutic-Goods-Amendment





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