Australasian Science: Australia's authority on science since 1938

TGA Endorses Pseudoscience for Complementary Meds

By Ken Harvey

We are about to be exposed to hundreds of approved “remedies” that are ineffective at best and potentially dangerous.

The full text of this article can be purchased from Informit.

Higher-risk medicines (all prescription medicines) are regulated by the Therapeutic Goods Administration (TGA) as registered medicines (labelled AUST R). They are thoroughly evaluated for quality, safety and efficacy prior to market release (except for some “grandfathered” products), and receive stringent post-marketing surveillance.

By contrast, most complementary medicines are regulated by the TGA as lower-risk listed products (labelled AUST L). These have no pre-market evaluation, limited post-marketing surveillance and no effective penalties for companies that breach the rules.

This “light touch” regulation trusts companies to meet TGA quality and safety standards and hold evidence supporting the indications and claims made. Regrettably, the trust placed in the complementary medicines industry is misplaced. The TGA’s limited post-marketing surveillance has consistently shown high levels (around 80%) of regulatory non-compliance. Many proposals to improve this situation are currently under consideration, the most recent being a TGA draft list of “permitted indications” for listed complementary medicines.

The aim was to eliminate the industry’s use of creative, voluminous free-text “indications” for their products, entered online (without TGA oversight) as part of their listing application and used in unjustified advertising claims.

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The full text of this article can be purchased from Informit.