In the same week that the TGA has removed over 400 alternative medicine products from the Australian Register, they are calling for submissions into how they can better improve their transparency. In a spot check on about 400 products, 9 out of 10 – or 26 per cent of newly listed medicines last financial year – were found to breach regulations and as a result a ‘’significant number” were removed from sale. The Australian Register of Therapeutic Goods or ARTG currently lists 10,250 complementary medicines, including vitamins, minerals and herbal preparations.
Ironically, the alternative medicine products which were withdrawn, largely as a result of false claims of curative powers on labels, were not named by the TGA, and the document said ”this information is not publicly available”. This doesn’t say much for the “transparency” of the TGA, as consumers who are still using the products are none the wiser that their potion doesn’t work.
The system for registering complementary and alternative medicines on the ARTG is open for abuse since the regulator does not ask for evidence that products work up front, rather relies on “self-assessment” by the applicant. Although the TGA website states “… evidence must be held by sponsors which demonstrates the indications and claims are true, valid and not misleading” the latest review indicates this is clearly not the case for the majority of products.
Instead of assessing evidence prior to registration, the TGA undertakes post market reviews where approximately 25% of products are randomly selected for a review of their labels, product specifications and summary of evidence. Given that 90% of products failed in the recent review, it seems clear that self assessment is not working.
A second issue is that even when products are removed from the listing, manufacturers can simply go back on line and re-register the product under a different name effectively getting it listed again in 24 hrs.
The recently announced comprehensive review of the way the TGA communicates regulatory processes and decisions to the public will include informing consumers that they only check complementary and alternative medicines for safety and quality, not for efficacy. Thus despite assigning an official looking number which lends legitimacy to the product, (consumes would be forgiven for assuming government approval) the TGA does not provide any assurance that the product works.
Further, instead of asking that sponsors prove their product works before listing them on the ARTG, the TGA will simply make consumers aware that these products probably don’t work, we dunno, there are no guarantees, we haven’t checked. Which makes the entire process appear ass-about doesn’t it?
The TGA are asking for submissions from the general public and from health professionals about the way it communicates regulatory processes and decisions to the public in an effort to improve transparency. You have until February 11th to have your say and details can be found on this website.
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