TGA has lost trust on CMs: Harvey


Dr Ken Harvey has again taken aim at the CMs sector, labelling it “a market flooded with shonky products and unethical claims”.

And consumers no longer trust the TGA to protect their interests, he claims, writing in MJA InSight.

“Since 2002, there have been 17 government consultations and reviews concerning the regulation of complementary medicines,” Dr Harvey writes.

“A consistent theme has been the absurdity of a ‘light-touch’ regulatory system for perceived ‘low-risk’ products that involves no pre-market evaluation, trusts sponsors to obey the rules and has no timely or effective penalties for breaches of the regulations.”

He cited recently published TGA data on post-marketing reviews of listed CMs, over the year between July 2015 and June 2016.

408 products were eligible to have their compliance status assessed, and 80% were found non-compliant, mainly to do with labelling, advertising and evidence requirements.

“These appalling statistics, which have not improved over recent years, are a sad reflection of the sorry state of this industry,” he writes. “They are also the reason why many consumers no longer trust the TGA to protect their interests.

“Reform has been stalled by consistent industry opposition, changing bureaucrats, changing ministers, changing government and changing policy, the latest of which was the Abbott government’s agenda for cutting red tape.”

He calls for the implementation of recommendations made in the Sansom Review, particularly those around a list of “permitted indications,” sponsors to publish evidence supporting claims, and a disclaimer on product labels and promotion stating that efficacy claims have not been independently assessed.

Dr Harvey also took aim at the TGA: “In October 2016, the TGA organised the first of several ‘targeted stakeholder forums’ on complementary medicine reforms.

“The TGA ‘forgot’ to invite a representative from either Choice or Friends of Science in Medicine (both of whom had been invited to the 2015 forums). After last-minute representations, I finally received an invitation to represent both these organisations

“At this latest forum, there were 14 people representing the complementary medicines sector.”

Dr Harvey writes that it is disappointing that no TGA staff member accepted an invitation to discuss these matters at the Australian Skeptics National Convention.

“My own view is that it is crucial to open the debate about the government’s response to the MMD recommendations beyond Complementary Medicines –TGA hegemony and obtain greater input from civil society,” he says.

“For example, the current TGA proposed list of ‘restricted indications’ contains many problematic entries, while only two industry bodies are in favour of abandoning pre-approval of advertising; most other stakeholders believe it should be extended and made more effective.

“If the TGA (and the government) is to regain the trust of the community with respect to the regulation of complementary medicines, then a more open debate about reform options is required.”

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