Aspen to pursue DPP appeal
September 13, 2012
ASPEN Australia has vowed to
continue its TGA appeal over the
decision to de-register Di-Gesic and
Doloxene, despite the TGAs
affirmation that it will cancel the
registration of the DPP products.
The TGAs move follows the
Administrative Appeals Tribunal’s
(AAT) June 2012 decision to remit the
matter to the TGA for reconsideration.
The AAT looked into the matter
after Aspen launched its appeal, and
made the decision to remit it back
to the TGA after hearing from the
parties and their respective experts.
The AAT was concerned that
Di-Gesic and Doloxene remain
available to patients “for whom
there is no suitable alternative to
analgesics containing DPP”, and
also said that “it is not appropriate
to refuse registration approval for a
preparation simply on the basis
that it may be used deliberately for
the purposes of self-harm”.
The AAT also accepted the
evidence of Professor Horowitz, an
expert cardiologist, that in the
ordinary circumstances of
prescribing, the potential for
sudden death is “about zero”.
This decision to remit the matter
back to the TGA is designed to
allow both the TGA and Aspen time
for both parties to explore whether,
in light of the AATs reasons, they
could find an agreed solution, rather
than having one imposed on them.
The AAT also said that if Aspen
remained aggrieved with the TGA’s
decision, it would have the right to
return to the AAT and continue the
review of the TGAs decision.
Aspen has said that it is likely to
exercise this right.
“Aspen understands that, like
many other prescription and overthe-
counter drugs, DPP has the
potential to cause harm if it is not
used appropriately,” Aspen said in a
statement.
“Aspen also recognises that it may
not be appropriate for DPP to be
prescribed to patients where
another moderate analgesic, such
as codeine or tramadol, adequately
relieves the patient’s pain.
“However, Aspen supports DPP
being available to patients who
need it, and who will be left
without satisfactory pain relief if
DPP is removed from the market.
“Aspen also believes this group of
patients should be able to access
their medication in a timely
manner, without incurring
additional supply costs,” the
company added.
MEANWHILE Aspen has also
stressed that Di-Gesic and Doloxene
will remain on the register while
the appeal is heard.
As such, doctors may continue to
prescribe both products after
carefully considering the
indications, warnings and
contraindications in the Product
Information and Consumer
Medicines Information for these
products.
“At Aspen, patient safety and
quality care are our top priority and
we will continue to operate with
the utmost integrity in meeting the
needs of the Australian
community,” Aspen said.
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