AUSTRALIA'S Therapeutic Goods Administration (TGA) has come under heavy fire again from industry watchdog Ken Harvey for its "light touch" approach to complementary medicines (CMs), in an MJA InSight article.
Harvey said the government's Expert review of medicines and medical devices regulation recommended many measures which, if implemented, could substantially improve the situation.
He highlighted recently released TGA data on post-marketing compliance reviews of CMs which found 80% of the 408 products assessed were found to be non-compliant, primarily with labelling, advertising and evidence requirements.
Further, around 98% of all complaints assessed by the TGA Advertising Complaints Resolution Panel (TGACRP) were upheld.
Harvey said the "light touch" approach meant that the TGA believed "low-risk" products required no pre-market evaluation, trusted sponsors to obey the rules and had no timely or effective penalties for breaches of the regulations.
Discussions between the TGA and stakeholders including the Complementary Medicines Association (CMA) have resulted in the TGA planning to release public consultation papers in February, probably for a period of six weeks.
Recently, the TGA was invited to talk at the Australian Skeptics National Convention from 25-27 Nov, but despite stating that they wished to engage more with consumers, no TGA staff were available to accept this invitation.
Harvey emphasised that it was important that the TGA regained community trust around CM regulation via a "more open debate about reform options".
The above article was sent to subscribers in Pharmacy Daily's issue from 08 Nov 16
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