Sydney Morning Herald | 9 March 2017

Trump plans threaten to weaken Australia’s drug safety regime

by Marcus Strom | Science Editor
Drug safety and regulation in Australia are under threat from US President Donald Trump, says leading Australian doctor John Rasko.

Professor Rasko, with two international colleagues from Japan and Canada, has penned a comment article in the journal Nature, published on Thursday, calling for the US Food and Drug Administration to continue regulation of pharmaceuticals for both efficacy and safety.

In January, Mr Trump told pharmaceutical industry executives: ‘‘We’re going to be cutting regulations at a level that nobody’s seen before.’’ Professor Rasko, who is head of cell and molecular therapies at Royal Prince Alfred Hospital and affiliated with the University of Sydney, said: ‘‘The most extreme proponents of deregulation say the market should be the sole arbiter of utility: if a medicine sells well, then it must be safe and effective. ‘‘If these sorts of changes go through, I can see a world in 10 years where the snake-oil salesman is back. It will all come down to marketing.’’

Mr Trump is vetting candidates for FDA commissioner. According to The New York Times, one candidate is Jim O’Neill, a former official at the US Health and Human Services Department. At a conference on ageing in 2014, Mr O’Neill spoke in favour of ‘‘progressive approval’’ for drugs, which would see pharmaceuticals proved safe for use, but not shown to be effective for treatment. Mr O’Neill said: ‘‘We should reform the FDA so it is approving drugs after their sponsors have demonstrated safety. Then let people start using them at their own risk.’’

Professor Rasko has responded to what he regards as a global

health threat. The authors say re- laxing the FDA’s regulatory system will subject patients to drugs that might be toxic.

‘‘All nations should take note – weaker standards for entry of drugs onto the US market will harm health everywhere,’’ Professor Rasko and colleagues write.

Professor Rasko told Fairfax Media the regulator in Australia, the Therapeutics Goods Administration, is fiercely independent. However, he said the FDA had a dramatic effect on the rollout of pharmaceuticals here. ‘‘The size and scope in the US in terms of population and money available means we rely on many of their studies,’’ he said.

The TGA and FDA maintain a memorandum of understanding whereby, among other things, both regulators are committed to ex- change information concerning ‘adverse health consequences’ of drugs.

‘‘No company would spend the tens of millions of dollars required to show that their drugs are effective if they aren’t required to,’’ Professor Rasko said.

A spokesman for federal Health Minister Greg Hunt said: ‘‘The TGA is acknowledged internationally as a first-rank regulator and has robust safeguards in place to ensure the safety of the Australian public. It will continue to be the government’s first line of defence in the regulation of medicines.’’