It seems to me trying to look at it objectively. The FDA is in an impossible situation forever.
If they delay drugs they are bureaucratic and indifferent. Filling graveyards, as said.
If they release drugs too fast/unproven then they open the gates to scammers, unethical companies trying to sneak ineffective products they spent too much on, ect. Basically the whole reason the FDA was formed would be in question. Then it sounds self serving but the people in charge will start to ask why do we even have the FDA? Which will drain funding then eventually set us back to the reason the FDA had to be invented in the first place. Snake oil salesmen will run rampant and we will need an agency to prevent dying desperate people being taken advantage of for whatever remaining money they have.
The FDA's position is that it's better for 10,000 patients to die of neglect than have 1 patient die of quackery.
Drug development takes 12 years [1] and costs >$2B (on average) because the FDA requires >99.99% confidence that pharmaceutical companies are not selling quack cures. Do we need that level of confidence? Especially for cancer, is that degree of confidence warranted? Is the process efficient? I think that it would be absurd to even argue these points.
There's legitimate fear of quack medicine and scammers -- and then there's whatever the FDA is gripped by, which seems to me a lot like insanity.
Unfortunately this is one of those subjects that turns off people's brain and turns on their emotions. It's disappointing to see so many HN'ers with their pitchforks out on this topic.
All the people on here with advanced degrees got them to kill orphans with drones right? Just like all the doctors they are accusing of killing people went to med school so they could kill people indirectly though policy.
The entire reason the FDA exists is that there is only a tiny sliver of people that can offer any real medical help to a dying person. Yet there are endless streams of con artists that will enthusiastically take the money of a desperate dying person because its easy. Shut off brain forgets that.
Based on my experience the actual solution is greatly expanding the FDA to allow them to be able to handle the highly increased flow of new research and create a central point for dying patients to find and get in programs. Right now they don't have the resources and have to rely on strict bureaucracy. Again the idea that the overwhelming majority of doctors would not jump at the chance to save people rather than put them in the ground slower is absurd.
The FDA needs overhauled so start contacting your senators is pretty much all we can do.
I don't think you understand how the process works.
The FDA's job isn't to hold your hand and get you into scientific research studies.
The FDA mandates certain steps -- the collection of certain data -- before it allows drugs to be marketed. Phase 1 is a safety study, Phase 2 is an efficacy study, and Phase 3 is a broader efficacy study. It is on the companies to collect this data; the FDA merely reviews it. (And then reddit-votes on which drugs to approve, with results that are sometimes funny, sometimes nakedly unethical e.g. flibanserin, and sometimes just ridiculous e.g. aducanumab.)
Having more FDA employees would not speed-up the process by much, as the data collection itself is the arduous bit, nor would it reduce expenses at all.
The best possible thing to do would be to simply get rid of Phases 2 & 3. That's how they did things until the early 1960s -- and, lest we forget, the 40s-60s were known as "the Golden Age" of drug development. Instead of increasingly onerous and expensive trials, allow drugs to be marketed once they're proven safe, and subject them to mandatory postmarketing surveillance.
Besides, that hard-won efficacy data is often interpreted (by the FDA!) in subjective and bizarre ways, so its value is not awfully high. It's not worth the price society is paying for it.
lol. It's not an explicit rule. It's their revealed preference. They're incredibly slow to act on approvals, inflexibly demanding of "data" that is difficult to obtain at best and completely unnecessary at worst, and they don't give a damn about the cost. (Both the near-term human cost, and the financial cost -- which goes on to reduce innovation in the drug business, leading to a further toll in human suffering.)
In the end, they've killed an awful lot of people via inaction, lack of urgency, lack of efficiency. But that's okay, because killing people via inaction is not quackery, after all. Better a million die of neglect than another thalidomide, the FDA would say.
If they delay drugs they are bureaucratic and indifferent. Filling graveyards, as said.
If they release drugs too fast/unproven then they open the gates to scammers, unethical companies trying to sneak ineffective products they spent too much on, ect. Basically the whole reason the FDA was formed would be in question. Then it sounds self serving but the people in charge will start to ask why do we even have the FDA? Which will drain funding then eventually set us back to the reason the FDA had to be invented in the first place. Snake oil salesmen will run rampant and we will need an agency to prevent dying desperate people being taken advantage of for whatever remaining money they have.