RU486 and the TGA
Decision on RU486 safety is to be made based on expert advice. The Therapeutic Goods Administration is currently considering an application, the Minister for Health and Ageing, Tony Abbott, said today.
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8 February 2006
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In an opinion page article published yesterday, Senator Lyn Allison said that the "TGA is expressly prohibited from assessing the safety of RU486 before the minister gives his approval".
The impression that any decision about RU486 would be made without expert advice is wrong.
As far as I am aware, the only application to use RU486 has been made under the Special Access Scheme for unregistered drugs.
The TGA is currently considering the application at arm's length from me. TGA advice would inform any ministerial decision on this application.
To aid the debate in the Senate, I wish to state that I would not make any decision that fell to me on the availability of a drug without first seeking relevant expert advice.
For more information call Mr Abbott's office on ph 02 6277 7220.
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