Regulation of complementary medicines

In this issue of the Internal Medicine Journal Cohen and Hunter have drawn attention to the challenge clinicians face when discussing the use of complementary medicine (CM) with patients. They note the difficulties in assessing the efficacy of these often-complex products and mention recommendations for more stringent regulation agreed to by the Australian Government in its Response to the Review of Medicines and Medical Devices Regulation. Subsequently, the Therapeutic Goods Administration (TGA) has fleshed out options for implementing these recommendations in four consultation papers that address many of the issues and concerns raised by Cohen and Hunter and others. Most CM are regarded as low-risk, self-medication products. They are regulated by the TGA as listed products (labelled AUST L). Listed CM have no pre-market evaluation, limited post-marketing surveillance, and no timely or effective penalties for sponsors who breach the rules. This ‘light-touch’ regulatory system trusts that sponsors will meet TGA quality and safety standards and hold evidence supporting the indications and claims made. In contrast, high-risk medicines (all prescription medicines) are regulated as registered medicines (labelled AUST R) and thoroughly evaluated for quality, safety and efficacy prior to market release (except for some ‘grandfathered’ products). They also have more stringent post-marketing surveillance. The TGA has recently published data concerning postmarketing reviews of listed CM. TGA compliance activity more than doubled from 212 (2014–2015) to 473 (2015–2016). Medicines with verified compliance breaches increased from 73% (2014–2015) to 80% (2015–2016). Labelling, advertising and evidence continued to be the major compliance breaches. In addition, for 2015–2016, the Therapeutic Goods Advertising Complaint Resolution Panel found 98% of 141 complaints justified (and a 40% non-compliance rate with Panel ‘requests’ for redress). The result is a market flooded with ingredient and/or products of doubtful value with claims that often go far beyond the limited (or absent) scientific evidence that sponsors are meant to hold to justify their claims. While there are a few evidence-based CM available (including some registered ingredient/products) the public has great difficulty in sorting out the wheat from the chaff. There is also little incentive for sponsors of CM to undertake the research required to prove that their ingredient/products work. A better return on investment comes from spending money on promotional hype and celebrity endorsement. The TGA Consultation paper, Reforms to the regulatory framework for complementary medicines: Assessment Pathways aims to address problems with the current listing (AUST L) and registration (AUST R) pathways. First, it is proposed to tighten up the claims that can be made for listed products by restricting sponsors to a limited list of pre-approved, ‘low-level’ permitted indications for an ingredient, such as, ‘may relieve the pain of mild osteoarthritis’. Second, a new assessment pathway will be offered by which sponsors can apply for ‘intermediate-level’ health claims that fall outside the permitted list (above). An example might be, ‘our formulation of cranberry powder reduces the frequency of recurrent urinary infections in women’. For this, the TGA will have to assess the clinical trial evidence substantiating the claim for the specific product. This addresses the concern of Cohen and Hunter that it is inappropriate to ‘borrow’ generic evidence about CM (especially herbal products) due to the complexity of the ingredients. If the TGA accepts the evidence provided, the sponsor could then show that the claim has been assessed by the TGA for efficacy on the product label and promotional material (by use of a ‘claimer’). The registration pathway will still be available for CM that have clinical trial evidence to support higher level claims and the use of a ‘claimer’ may also be approved. Third, it is proposed that a sponsor would be given a 2-year period of market exclusivity for working up a new ingredient approved for use in a listed medicine. In addition, a sponsor who provided data for an approved evidence-based claim would be awarded a 3-year period of data protection. Furthermore, registered CM would be given a 5-year period of data protection for new active ingredients. This should encourage competition and innovation and eliminate ‘copy-catting’ or ‘free-loading’ by competitors. The TGA Consultation paper, The regulatory framework for advertising therapeutic goods, aims to address problems that have emerged in this area. Currently, Australia has an excellent Therapeutic Goods Advertising Code but a complex, overloaded and under-resourced complaint system that provides no effective penalties for Code breaches. It is proposed to disband the current system for