Review into TGA transparency

A review into the transparency of the Therapeutic Goods Administration, the body that is tasked with establishing and maintaining a “national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods”, has found that the TGA has been conservative in its actions and that it can do a lot more to keep the public informed of its deliberations and processes.

“It was apparent that the expectations of the public are not being met and there is more the TGA can do,” the review’s report says. “The decision to establish the review reflects community concern about the lack of information made available by the TGA.”

With a suggestion that the TGA was serving the industry rather than end-users, the report says that “It is necessary for the TGA to recognise that it serves multiple stakeholders and that it must adapt its communication strategies accordingly. Consumers and health practitioners have as much interest in therapeutic goods as the industry that produces and markets those goods.”

Quoted in The Australian newspaper, former Commonwealth ombudsman and head of the inquiry, Prof Dennis Pearce, said “Even among health industry people, they seemed to find it easier to get information from the US Food and Drug Administration website than to find out things that are happening within the TGA.”

The review was looking at the TGA’s level of communication, not how – or whether – it actually undertakes reviews of medical products and devices, though this has been the subject of much criticism in the past. Recommendations therefore concentrated on ways to improve its online presence, information on its members and activities, principles of consultation, etc.

However, many of the submissions to the review did mention the TGA’s approach to testing products.

This might have been reflected in the review panel’s executive summary, which suggests that “the TGA should adopt a pro-active stance to many issues relating to therapeutic goods that are of concern to the public that it serves. It should move away from the conservative approach that has characterised its actions in the past and 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.”

One area that was raised in the recommendations was the TGA’s work with stakeholders “to improve labelling and packaging requirements to educate and assist consumers and health practitioners to make informed decisions about the quality use of therapeutic goods”.

While it wasn’t specifically recommended, the possibility of symbols on labels to indicate risk levels was raised by some submissions to the review, including by the TGA’s own Advisory Committee on the Safety of Medicines (ACSOM), which drew the review panel’s attention to the lack of public awareness of the uncertainties of medicine safety in the early post registration period for medicines requiring a risk management plan.

ACSOM proposed that a new risk communication scheme be introduced to alert consumers and health practitioners to the level of risk in the early post-market period. The scheme would be similar to the United Kingdom’s ‘black triangle’ alert system.

“Health professionals would be particularly encouraged to report adverse events that appeared to be related to drugs with the early postmarketing symbol,” ACSOM said.

However, “while panel members agreed with the concept of an ‘early post marketing risk communication scheme’, some members are opposed to the use of the United Kingdom’s black triangle as they interpreted it as being ‘sinister’, and not as a cautionary symbol to raise awareness of a product’s recent approval. However, the symbol (or a variant) is used, or is to be introduced, in other European countries.”

Submissions to the review included those from Australian Skeptics Inc vice-president Rachael Dunlop and the Victorian Skeptics.

One of the submissions was from the Complementary Healthcare Council of Australia, which said that it “does not support disclosure of product information in relation to ingredients/formulas as this encroaches on commercial-in-confidence details. The complementary medicine industry already struggles with the lack of exclusivity/data protection available impacting on competitiveness and innovation in the market. The CHC believes publicly disclosing additional product information would not benefit consumers but lessen the forces of competition.”

The CHC was, in fact, part of the review process itself with two representatives sitting on the panel, the only organisation to do so apart from the Consumers Health Forum of Australia, which had three representatives. The CHC includes among its members the Australian Homeopathic Association.