Not a good week for the Therapeutic Goods Administration and QUM

The Therapeutic Goods Administration (TGA) is charged with ensuring Australians can have confidence that the medicines and devices and other therapeutic goods that are sold in Australia and safe, effective and manufactured well. At a high level the role of the TGA is to practice evidence based medicine (EBM) and quality use of medicines (QUM). The last fortnight has seen poor outcomes on all fronts and both in the area of conventional and complementary medicines regulation.

In the first case a TGA proposed ban on combination products containing detropropoxyphene (DPP) was overturned by the Administrative Affairs Tribunal. DPP has been associated with death due to cardiac toxicity, albeit often in the situation of overdose. It is not considered to be a superior analgesic to common alternatives. Internationally the drug has been withdrawn from a number of jurisdictions because of safety concerns and available alternatives.

In the second case the vitamins giant Swisse has bypassed a ruling of the TGA that its’ diet pill does not have evidence to support its’ claims and has renamed the product and re-worded the claim. The product itself is the same. The registering process provides not oversight of this process and it can only be addressed through appeal.

Regardless of its’ best intentions in these cases the TGA seems hamstrung by the Act under which it operates. This is too the detriment of the general public and not in the spirit of the National Medicines Policy. In one case there is increased risk of harm without added therapeutic benefit, in the other little evidence of benefit. What is needed it not necessarily more onerous regulation but more thoughtful regulation and also education of the public, particular around complementary medicines.

These comments reflect my own personal opinion and not those of NPS Medicinewise.

http://www.smh.com.au/national/health/name-change-helps-swisse-sidestep-ban-on-hunger-product-20130411-2hokj.html

http://www.austlii.edu.au/au/cases/cth/aat/2013/197.html

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