Donald Trump's FDA plans makes sense
When getting a new drug past the regulators can cost up to a billion dollars, it's no wonder that drug costs are so high. The manufascturers have got a huge investment to recoup. The probable Trump solution could cut costs drastically: Have the FDA rule on safety only, with efficacy left up to doctors to decide on, based in part on their own experience. Manufacturers will alway show what efficacy proof they have and manufacturers of rival drugs will always be quick to point to failures in efficacy trials of rival products.
The galoots below are so entrenched in their negativity that they say the new move will unleash dangerous drugs on to the market. How so? Nobody is proposing to lower the standards of safety testing. That should continue as before
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."
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 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.
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".
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."