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Comment by esyir | Hacker News Reader

Feels like this is the fundamental flaw with a lot of things not just in the private sector, but the public one too.

Look at the FDA, where it's notoriously bogged down in red tape, and the incentives slant heavily towards rejection. This makes getting pharmaceuticals out even more expensive, and raises the overall cost of healthcare.

It's too easy to say no, and people prioritize CYA over getting things done. The question then becomes how do you get people (and orgs by extension), to better handle risk, rather than opting for the safe option at every turn?

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I take your broader point but personally I feel like it’s ok if the FDA is cautious. The incentives that bias towards rejection may be “not killing people”.

What about the people who die because a safe and effective drug that could have saved their life got rejected? The problem is that there's a fundamental asymmetry here - those deaths are invisible but deaths from a bad drug that got approved are very visible.

I mean drugs are different than consumer technology. Instagram isn’t great but it doesn’t cause birth defects. Also things like the compassionate release of hiv drugs in study show the govt can see the nuance here with enough pressure.

Or, to cite a more recent example, fast-tracking COVID-19 vaccine approval.

I deliberately chose the FDA here specifically because of this. The problem here is that on a societal level, we have to be willing to tolerate some risk. If a drug could have saved many, but is rejected because of occasional complications, that sounds like a poor cost benefit analysis.

You have a flawed understanding of the FDA pharmaceutical approval process. There is no bias towards either rejection or approval. If an drug application checks all the required boxes then it will be approved.

I think the reason why some people mistakenly think this makes healthcare more expensive is that over recent years the FDA has raised the quality bar on the clinical trials data they will accept. A couple decades ago they sometimes approved drugs based on studies that were frankly junk science. Now that standards have been raised, drug trials are generally some of the most rigorous, high-quality science you'll find anywhere in the world. Doing it right is necessarily expensive and time consuming but we can have pretty high confidence that the results are solid.

For patients who can't wait there is the Expanded Access (compassionate use) program.

https://www.fda.gov/news-events/public-health-focus/expanded...

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