Australians seem to know more about the US Food and Drug Administration (FDA) than their own pharma regulator, the Therapeutic Goods Administration (TGA), and the FDA's information is as likely to be relied upon as that from theTGA, says an official government report.
The report follows an investigation into transparency issues at the TGA, which was ordered last November by the Parliamentary Secretary for Health and Ageing, Catherine King, as a result of the widespread belief that the TGA "does not provide the public with sufficient information about its activities and about the therapeutic goods that it regulates," says the review panel, which is chaired by Professor Dennis Pearce.
The panel's findings are that, while the agency has done much in recent years to increase stakeholders' knowledge of its role and functions, "the expectations of the public are not being met and there is more that the TGA can do."
Moreover, the agency needs to recognise that it serves multiple stakeholders and that it must adapt its communications strategies accordingly, says the report. "Consumers and health practitioners have as much interest in therapeutic goods as the industry that produces and markets those goods," it notes.
The review panel urges the TGA to move away from the conservative approach that has characterised its actions in the past and to adopt a "pro-active stance to the many issues relating to therapeutic goods that are of concern to the public it serves." The agency also needs to "recognise that it has a duty to collaborate with stakeholders to create a culture in which the community has confidence in the therapeutic goods the TGA regulates," it adds.
Pointing to the trend by other regulators - such as the FDA, the UK Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and Health Canada - towards greater openness, the panel warns: "Australia cannot afford to be left behind in this worldwide approach to the regulation of therapeutic goods."
It also notes the announcement last month that the Australian and New Zealand governments have agreed to proceed with a joint scheme for regulating therapeutic goods. While this news came too late to be taken into account for the review, the panel members say they do not believe the new arrangements will affect implementation of the 21 recommendations they make for improving the system.
The panel's findings have been welcomed by Australia's Consumer Health Forum (CHF), which said it will press the government for speedy implementation of the recommendations for change. "The capacity of the TGA to monitor and regulate therapeutic goods in Australia has, in the past, been hampered by poor public understanding of the organisation's important role," said the CHF's chief executive, Carol Bennett.
The research-based industry group Medicines Australia added that the TGA had already made significant progress in reforming its business processes, and that the reforms recommended by the panel would "help demystify the regulatory process for the ordinary Australians who benefit from it."
Responding to the panel's report, Ms King said she was pleased by the depth of interest in the review. "It is important that the community understands the TGA and its processes as the decisions it makes have a profound impact on the public health of the nation," she said.
The government says it will now "fully consider” the review panel's report and provide a formal response.