Trump is very critical of the FDA, calling their drug approval process ‘slow and burdensome’(1). Although it's not clear how he would go about changing the FDA, there are speculations (2) that Trump might try to implement a "right to choose" option. Until now, drugs that passed pre-clinical trials would need to go through 3 testing phases, one more rigorous than the other, before finally being considered for a FDA review. the whole process is burdensome and is both time-consuming and resource intensive. The right to choose path would allow patients to opt-in into getting drugs that have passed the first 2 testing phases. such a drug would be labeled "approved by the FDA based on promising but provisional research."(ibid)
phase III clinical trials represent 90-plus percent of the cost of drug development.
which means, by cutting phase III, you could potentially be saving patients a ton of money.
The enormous cost of phase III trials, Mr. Roy argues, does not encourage work on drugs to treat common conditions that affect hundreds of millions of Americans, such as diabetes and cardiovascular disease.
In addition, says Mr. Roy, phase III cost burdens prevents smaller companies from challenging the dominance of big pharmaceutical companies, stifling innovation and encouraging monopolies.
and we all know how well the current FDA drug process works: just look at artin Shkreli of Turing Pharmaceuticals and how he was able to raise a life-saving drug by over 5000% (3) because the current FDA process made competition virtually impossible. if you or your loved one relied on the drug....tough luck. things have changed, but the Turing incident does show the limitations of the current FDA approval process. it encourages drug monopolies.
Conservative news such as The Hill are rejoicing, saying that letting people choose would make drugs more affordable (4), while the left media is panicking, pointing out that there may be a conflict of interest(5), though no proof was given (it;s ok to roll your eyes). some even think "free to choose" drugs would be inefficient and has "poor results" (6)
studies seem to challenge such a claim, however:
But the FDA’s well-intentioned focus on large-scale trials—which can better uncover potential side effects and provide a more complete portrait of a drug’s risk-benefit profile—may be harming more patients than it helps.
A 2010 study in the Journal of Clinical Oncology found that the drug development process increased from an average of eight years in 1960 to 12-15 years in 2010. Lengthier trials meant to eliminate toxic new drugs, the researchers concluded, resulted in the loss of 300,000 patient life-years while saving just 16 life-years.
Similar results were found in a National Bureau of Economic Research study that measured the impact of accelerated FDA approvals. The faster approvals saved up to 310,000 life-years, versus 55,000 life-years potentially lost due to dangerous drug side effects.
bottom line: speeding up the drug approval process could prove to be very beneficial to patients, overall. unless Trump decides on something completely different. in which case, all bets are off.
tl;dr Trump might let people choose drugs that has passed almost all FDA tests, saving patients a ton of money.
studies suggest such a move would be very beneficial to patients.
assuming Trump actually does this, of course.
do you guys agree with this? if not, why?
(i originally posted elsewhere, but i think it might be useful to post here as well)
I don't think it'll help my mentally ill brain