E-DRUG: Australian TGA told to open up and get on front foot
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[copied in the public interest]
http://tinyurl.com/4xplhj3
Natasha Bita, Consumer editor | The Australian | July 21, 2011
AUSTRALIA'S medicines watchdog is set for a shake-up after an inquiry
criticised its secrecy and inefficiency.
An eight-month investigation into the Health Department's Therapeutic Goods
Administration (TGA) has called on the industry-funded regulator to publish the
results of all its safety investigations, and improve the way it gathers and
reports the side-effects of medicines and vaccines.
The inquiry's report, released yesterday, says the TGA should investigate
putting a new "black triangle" logo on the packets of all new medicines, to
warn the public that the safety of newly approved drugs has yet to be proven
in the marketplace.
It concludes that Australians know more about US regulator the Food and
Drugs Administration than their own TGA.
"It's a worry," said the head of the inquiry, former commonwealth ombudsman
Dennis Pearce. "Even among health industry people, they seemed to find it easier to get
information from the FDA website than to find out things that are happening
with the TGA.
"The TGA should be listening to what people want and meeting their requests
but there has been a tendency to not pay as much heed to the needs of
consumers for some time now."
Professor Pearce called for some taxpayer funding of the TGA, the world's
only industry regulator entirely funded through levies on the pharmaceutical
sector. The TGA was funded by taxpayers until 1998, when the Howard
government switched to full cost recovery.
He said the TGA should publish the agendas and minutes of its advisory
committees, subject to commercial confidentiality restrictions.
"They do practise a fairly strict conflict of interest process (but) we have
suggested that conflicts of interest (among TGA advisers) be made clearer
and be announced," he said.
The report concludes that "the expectations of the public are not being
met".
"The TGA should adopt a proactive stance to the many issues relating to
therapeutic goods that are of concern to the public it serves," it says.
"It should move away from the conservative approach that has characterised
its actions in the past."
The report says the TGA has an ongoing responsibility to monitor the safety
of products after it approves their use, and let the public know about any
new information that "changes the risk-benefit ratio".
"It is also essential that the TGA's independence from sponsors and fairness
in decision-making be reinforced by openness in its dealings," it says.
The report says the TGA should let the public search its database of
"adverse events" to drugs and vaccines.
It says the public does not understand that the TGA does not individually
assess "low-risk" medical products, but relies on information from the
manufacturers. Complementary medicines, such as vitamins and other
alternative health products, are not evaluated by the TGA at all.
Consumer Health Forum chief executive Carol Bennett -- a member of the
inquiry, which included representatives of the Australian Medical
Association, the pharmaceutical industry and consumer groups -- yesterday
called on the government to make the changes recommended.
"There's been too much secrecy about what the TGA does," she said.
"It is time they had some transparency and accountability."
A spokesman for Parliamentary Secretary for Health Catherine King said the
government was still considering the findings.
The report is available at:
http://www.tga.gov.au/newsroom/review-tga-transparency-1101.htm
Posted by Dr Ken Harvey
Australia
"Ken Harvey" <k.harvey@medreach.com.au>