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2 Comments

  1. 1

    Treenan

    What a strange article. Much of what the authors argue is reasonable, but some of it is bizarre.

    Certainly there should have been some communication from TGA in response to the FDA’s findings regarding Ranbaxy. That said, I would imagine that, at any given time, TGA is investigating dozens of drugs or devices for safety and other compliance issues, and that many of those investigations would come to naught.

    But most practitioners within the TGA seem capable and diligent. Are the authors suggesting that all of this investigation should take place in public view? I cannot think of a better way to hamper, even cripple the investigation process.

    At the present time TGA does have a senior management team many of whom appear to lack both experience and expertise, especially when it comes to communication. This is exacerbated by the longstanding ‘do not engage with the press’ policy that comes from the central office of DoH.*

    Thalidomide is of course introduced – disingenuously – as a shock example of regulatory failure – ignoring that the terrible occurrences related to that drug took place before TGA existed. Nice straw man though.

    “Effectively, regardless of how negligent the TGA is in carrying out its job as the regulator, it cannot be sued by anyone who is harmed by its actions …” It’s as well that the authors were not acting as legal advisors to the litigants in the Pan Pharmaceuticals case, settled against TGA and some of its officers in 2011.

    * The Secretary appears to be running an ‘as few doctors and other health professionals as possible’ policy – with an ever dwindling number in DoH (excluding those in TGA) – which has been quite effective in recent years. This seems to operate in tandem with a ‘the more lawyers the better’ policy.

    Disclaimer: I do not work, nor have I ever worked, for, in or with the TGA or the Department of Health.

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  2. 2

    Bruce Arnold

    It is deeply saddening (and should be of public concern) that the TGA has had to be poked and stroked into acknowledging that there are concerns among clinicians, regulatory specialists and members of the public regarding overseas manufacture of generic pharmaceuticals.

    Those concerns are substantive, demonstrated through the FDA banning imports of medications and the FDA’s imposition of a US$500 million penalty. (People who have US$500 m in spare change are welcome to send it to Australian hospitals and universities).

    The TGA is an important agency, staffed by people who have Australia’s well-being at heart. Unfortunately, as at least four major inquiries have demonstrated, on occasion it has been grossly ineffective. As the authors demonstrate in forthcoming research, communication is very important. The TGA has acknowledged the importance of communication – and its past failures in that respect – through a recent ‘progress report’ in which it acclaims its effectiveness in communicating with the community at large. Today’s statement by the TGA is late: there is no substantive reason why it could not have been made weeks ago. If the FDA takes community concerns seriously enough to communicate with its public, why has the TGA been silent until now. It is imperative that the TGA actively and positively engages with the community. Its failure to do so fosters anxieties that will often be unnecessary.

    Regrettably, the FDA and ongoing revelations from within India demonstrate that there ARE substantive concerns. Mislabelling of medications such as Lipitor is serious. Contamination is serious. Those concerns should not be dismissed by claiming that they are not a ” medicine safety issue”.

    More timely, consistent and open communication on the TGA is both feasible and imperative. It is not luxury. It will not produce harm. It is entirely consistent with the TGA’s own policy documentation. Without any disrespect for the TGA CEO it is time for the organisation to be more open. The TGA will not be able to save us from all harms but greater openness with foster the trust and credibility that has been eroded by past failures.

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