So the question is, what can Australia's Therapeutic Goods Administration (TGA)do about this? The logical recourse for new data pointing to serious problems with a therapeutic drug is that there should be the possibility of restricting its consumption on safety grounds. A proper investigation might be called for. Here's new data, two new deaths linked to RU-486. On top of several others in the past which has prompted a ban on RU-486 in other countries. The Health Minister used to have the power to restrict the drug for such reasons, but legislation's already been passed and the TGA is now in charge. What can the TGA do about the new data?
Unfortunately, it doesn't seem to have any ability to do anything. It was a serious concern by the Australians Against RU486 that the TGA "does not receive public funding and is dependent on the results of drug company trials and scientific studies". This was claimed by the recent Medical Director of the TGA, Dr McEwen. He also admitted that "his office is currently powerless to review a drug once it has been given market approval." Perhaps worst of all, he also revealed that guidelines set by the TGA are NOT ENFORCEABLE.
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