Pharmacy Daily | Auditor shakes-up TGA

A NEW report by the Australian National Audit Office (ANAO) into the role the Therapeutic Goods Administration plays in regulating complementary medicines, has found that despite rapid market growth, complementary drug compliance with national standards is low. To combat this growing problem the ANAO made a number of recommendations to the Dept of Health (DoH), including that the DoH provide a target date for the completion and publication of each key complementary medicine guidance document. In addition, the ANAO said that the DoH should provide regular progress reports on the development of key guidance documents, on the TGA website, to keep industry, health professionals and consumers informed. Currently there are around 10,000 complementary medicines for sale on Australian shelves, and the incoming tide is not slowing, with market growth estimated at between three and 12% per year. Last year sales of complementary drugs were estimated at 1.2 billion, whilst worldwide sales were said to sit at around US$83b. According to the ANAO, due to the perceived “low risk” nature of complementary medicines, regulatory guidelines have tended to have a “light touch” so that market access to the products is not “impeded unnecessarily”. Last year a TGA review of 31 randomly selected complementary drugs on sale in Australia, found that 90% of the medicines were not compliant with regulatory requirements. Taking these trends into account the ANAO strongly recommended that the DoH seek to finalise the work on the TGA’s ‘coded indications’ project, which is aimed at restricting the ability of drug sponsors to enter free text into the TGA’s online Electronic Listing Facility. According to the ANAO, this free text ability “permits inappropriate or misleading claims and indications to be made by sponsors through the deliberate or inadvertent entry of information”. In addition the ANAO said that the TGA should use its random sampling review of listed drugs to develop risk profiles against the most significant characteristics of listed medicines and the less compliant sponsors and manufacturers. In terms of transparency, the ANAO said that the TGA should make information for each listed complementary medicine (including whether it has been subject to a TGA post-market review, when it was reviewed and the outcome), available to the public in a “timely manner”. Lastly, the ANAO recommended that the TGA adopt a standard operating procedure for completing investigations of advert breaches, incorporating appropriate timeframes for completing the investigations; and the provision of regular reports to the TGA executive on investigative progress and trends in non-compliance.

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