Has AAT taken TGA’s teeth?
September 17, 2012
THE Consumers Health Forum has
hit out at the Administrative
Appeals Tribunal (AAT), questioning
the process whereby the
committee can over-ride the
“independent scientific and clinical
views of the dedicated national
medicines regulator, the TGA”.
The comments come in response
to steps Aspen has taken to appeal
to the Administrative Appeals
Tribunal (AAT) the decision of the
TGA to cancel the registration of
two painkillers containing
dextropropoxyphene (DPP) –
Doloxene and DiGesic (PD 13 Sep).
Whilst the CHF welcomed the
TGA’s confirmation of its original
decision to remove the DPP
painkillers following the AAT review,
the forum said that the AAT process
undermines patient safety.
“The confirmation by the TGA
that this drug compromises patient
safety and should not be available
to the public again highlights a
major flaw in our medicines policy,”
said Consumers Health Forum CEO
Carol Bennett.
“How can we allow a
pharmaceutical company to use an
administrative appeals process to
prolong the sale of a product that
the TGA has found could be causing
harm to Australian health
consumers?
“This situation must be rectified,
not just for this drug, but for all
drugs found to be unsafe by the
TGA,” she added, saying that the
“bottom line” is that Government
has a responsibility to ensure the
regulatory framework
operates effectively.
“And if this is not a failure, what
is?,” she added.
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