Transparency and the Therapeutic Goods Administration
- Ken Harvey
- Aust Prescr 2013;36:110-1
- 1 August 2013
- DOI: 10.18773/austprescr.2013.043
The Therapeutic Goods Administration (TGA) regulates medicines and devices in Australia. In 2010 and 2011 there were major reviews of the TGA in response to health professional and consumer concerns. These culminated in several reports, including two government papers:
These documents outline a four-year timetable of incremental reform aimed at increasing the transparency of TGA regulatory processes and decisions, and enhancing public trust in the safety and quality of therapeutic goods. Several reforms have already been implemented while many others are underway.3,4
An Australian Therapeutic Goods Advisory Council5 has been established to encourage wider community input into the future direction of the TGA, including the implementation of the reforms. It has held two meetings to date. The Council website includes an email contact address which could be used to communicate ongoing concerns to council members.
The TGA website (www.tga.gov.au) has been improved to provide better access for health professionals, consumers and industry. It is now possible to search the TGA’s database of adverse events from medicines, to access product information and consumer medicines information, and see product alerts and recalls. You can search the Australian Register of Therapeutic Goods (ARTG) to see if a product is currently authorised for supply in Australia and view its ingredients. Although there is a summary of the product, for listed complementary medicines the information is provided by the sponsor without independent assessment by the TGA. This information may not be in accordance with scientific evidence.
Other useful information is also available on the TGA website, but can be difficult to find. An example is a small list of registered complementary medicines that have been evaluated by the TGA for safety, quality and efficacy.6 Surprisingly this list contains one formulation of glucosamine hydrochloride. When the TGA was queried as to why this product was registered, it noted that the product was evaluated by the standards of the time (1999). Its inclusion on the TGA list highlights a fundamental problem of TGA registration of both complementary medicines and prescription medicines. While safety information is updated by the sponsor and the TGA, amending other product information, such as a change of dose interval, requires a formal submission from the sponsor which they may not feel is worthwhile to do.7
Another example of useful information (found under the headings ‘Industry, Complementary medicines, Regulatory decisions and notices’) is a list of cancellations from the ARTG following compliance review. Ironically, cancelled products can be quickly relisted by the sponsor, for example by making minor changes to the label. This practice was highlighted by a recent ABC TV program, ‘The Checkout’.8
The outcomes of some TGA investigations into advertising complaints about complementary medicines referred from the Complaints Resolution Panel (CRP) are also available.9 Some of these ‘outcomes’ merely record years of continued noncompliance with CRP and/or TGA ‘Regulation 9 orders’, for example, Bayer’s Berocca Performance (Complaint No. 2010-10-017), and Homeopathy Plus (Complaint No 2011/05/004). This highlights the current impotence of the TGA with respect to imposing timely and effective sanctions on advertising violations, although there is a proposal to enhance the sanctions.10
The CRP has stated, 'Regulation 9 orders issued by TGA for advertising complaint determinations finalised by the Panel after 1 November 2010 will be publicised on the TGA's website'. In fact, since November 2010 at least 88 complaints have been referred to the TGA by the CRP because of non-compliance, of which only 14 have an 'outcome' recorded on the TGA website. In response to a query about this matter the TGA said, 'As part of the implementation of the Transparency Review, consideration is being given to publishing the outcome of all advertising complaint investigations in the future'.
Australian Public Assessment Reports for prescription medicines (AusPARs) summarise the evaluation process that led the TGA to approve or not approve a drug for use in Australia. They can be found using the search function. There has been some concern that since AusPARs were introduced the TGA has stopped publishing the resolutions of the Advisory Committee on Prescription Medicines. Another problem is that a drug can appear on the Australian market before the AusPAR is available.
In short, a good start has been made, and there are many more reforms to come. The implementation of some reforms will be protracted as regulatory impact statements and amendments to the Therapeutic Goods Act 1989 or TGA regulations will be required.
Dr Harvey has represented consumer organisations on the TGA Transparency Review Panel, the TGA informal working group on the regulation of complementary medicines, and the Working Group on Promotion of Therapeutic Products, Department of Health and Ageing.
Adjunct associate professor, School of Public Health, La Trobe University, Melbourne