[haldujai]

For drugs approved between 2011 and 2015 the FDA approval time was a median 303 days, faster than the EMA at 369 days.[1]

For drugs approved between 2000 and 2010 (for all 3 agencies, the FDA gets more applications) the FDA approval time was a median of 268 days, faster than the EMA at 356 days and Health Canada at 366 days.[2]

Based on your assertion and the data this means that you think all three of these agencies are harming the population, with the FDA being the lesser of all evils, by not approving drugs fast enough. Do you have a source for this claim?

[1] https://www.nejm.org/doi/10.1056/NEJMc1700103

[2] https://www.nejm.org/doi/full/10.1056/NEJMsa1200223

[astrange]

Here's an article from 2014 about how the EU has approved twice the sunscreens the US has:

http://www.slate.com/articles/health_and_science/medical_exa...

It's still true, we still don't have them. Obama even passed a law about it and it didn't help.

> Based on your assertion and the data this means that you think all three of these agencies are harming the population, with the FDA being the lesser of all evils, by not approving drugs fast enough. Do you have a source for this claim?

This is obviously true. Are Americans, Canadians and Europeans all different species? No. Are all three countries slash political unions capable of running clinical trials? Yes. Do the FDA or Health Canada trust each other enough to allow things the other approved? No.

Although the FDA is sometimes surprisingly relaxed - here's a nootropics company selling drinks with at least two unapproved medications in them, adrafinil and omberacetam: https://www.trubrain.com/products/drinks.

[haldujai]

Unless I'm missing something this is completely unrelated to and does not substantiate your argument that drug approvals are harming patients with the "mostly harming" argument implying more harm is being caused than prevented by current approval processes.

Once again, source?

> This is obviously true.

As you only mentioned the FDA, and keep only mentioning the FDA, it is not obviously true that you are arguing against all Western drug approval agencies and not specifically the FDA.

> Are Americans, Canadians and Europeans all different species?

All being the same species does not mean all have the same regulatory framework and in fact they don't. I am sorry but I really don't understand any of the points you're trying to make.

[astrange]

> Unless I'm missing something this is completely unrelated to and does not substantiate your argument that drug approvals are harming patients with the "mostly harming" argument implying more harm is being caused than prevented by current approval processes.

Not having sunscreen harms people by giving them skin cancer.

> As you only mentioned the FDA, and keep only mentioning the FDA, it is not obviously true that you are arguing against all Western drug approval agencies and not specifically the FDA.

I didn't say anything about them in my original post so I'm certainly open to believing they're also too slow.

Europeans certainly seem to believe a lot of strange things about American food that are just protectionism from their farmers.

> All being the same species does not mean all have the same regulatory framework and in fact they don't. I am sorry but I really don't understand any of the points you're trying to make.

Yeah but that's bad. It's also eg bad that every American city has completely different housing regulations.

[haldujai]

I'm not sure how to communicate this more clearly. I'll try one last time.

My only question to you is this, you said:

"The FDA mostly harms the population by not approving drugs fast enough."

Do you have a source that says on the whole the FDA harms more people by not approving drugs more quickly, MORE than any safety added by this process.

Please note this would mean a citation that has looked at MANY approvals and timelines while ALSO looking at rejections for potential harm and concluding that the process is more harmful than beneficial.

To explain to you why yours is insufficient, even if we accept that this ONE example has caused harms you have not addressed any potential safety issues that have been prevented in OTHER therapeutics by the long process, this may in fact be zero or less than the harms caused by delays but requires evaluation in order to draw the conclusion you are making.

[loeg]

I don't follow or care about the EMA or HC because I don't live in Europe or Canada. Nevertheless, the FDA sucks.