Donald Trump’s FDA plans could affect drug regulation in Australia

by Marcus Strom

Sydney Morning Herald 9th March 2017

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 as President Trump talks of the need to reduce drug prices by streamlining the FDA approval process for new medicines, and bringing drug makers back to the United States.

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.”Professor John Rasko, head of cell and molecular therapies at Royal Prince Alfred Hospital.

He told Fairfax Media: “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 FDA so it is approving drugs after their sponsors have demonstrated safety. Then let people start using them at their own risk.”

Professor Robyn Ward from the University of Queensland is chairman of the Commonwealth Medical Services Advisory Committee. Photo: Louie Douvis

Professor Rasko has responded to what he regards as a global health threat. The authors say relaxing 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 that the regulator in Australia, the Therapeutic 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 exchange information concerning “adverse health consequences” of drugs.

Professor Rasko said the removal of US-based studies would have an economic and health impact.

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

These arguments are largely supported by Professor Robyn Ward, deputy vice-chancellor of the University of Queensland. Professor Ward is also chairman of the Commonwealth Medical Services Advisory Committee and a member of the Pharmaceutical Benefits Advisory Committee.

“The world relies on the collaboration of many countries for drug regulation,” Professor Ward said. “Removing a country as large as the US would slow down progress and scientific advance.”

Professor Terry Campbell, who is is head of the department of medicine at St Vincent’s Hospital, said he was “inclined to agree with” the authors of the Nature article but noted “there is still a strong public health lobby in the US”.

“Trials will still happen. Big cancer drugs won’t be bought if they aren’t proven effective.”

Professor Campbell, who sat on the PBAC for 16 years to February this year, also said that even if the FDA changed its regulatory stance, “I can see no way that the Europeans would allow marketing without proving efficacy”.

However, he said: “Any shift in this direction from the FDA would make life a lot more difficult.”

Professor Ward warned that FDA deregulation could squeeze out the smaller medical companies.

“Smaller companies offering innovative solutions could have less traction because they have smaller marketing budgets than the big pharmaceutical companies,” she said.

“It will be a race to the bottom. Market forces would drive prices up based on popularity, not efficacy.”

Professor Rasko in Nature argued that “unregulated markets are hopeless at sifting out futile drugs”. “Witness the multibillion-dollar industries in homeopathy and other pseudo-medicines,” the authors say.

Professor Rasko said: “Rigorous clinical studies are still the best way to learn whether a drug works and regulation is essential to ensure that these studies are conducted.”

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.”

The Nature article was jointly written by Douglas Sipp from the Riken Centre for Developmental Biology in Japan, Christopher McCabe, a health economist at the University of Alberta in Canada, and Professor Rasko.

Read the article at Sydney Morning Herald