I found this very insightful! By now, I have heard people rage about the FDA so many times but still don’t have great clarity on what exactly makes (parts of it) so terrible.
Also I would like to learn more about the differences between Europe and the US in device and drug approval processes.
You have written about the FDA multiple times. What makes you personally so interested in this topic?
I got interested in Feb 2021 when trying to figure out why the AstraZeneca vaccine hadn't been authorized in the US when there was really good Phase III trial data to support it and it had been authorized in the UK at the end of December.
It led me down a rabbit hole where I was reading the FDA critiques of Alex Tabarrok and others.
I have been meaning to do a blog post summarizing all the things that went wrong at the FDA during the pandemic and calling for a congressional inquiry. Maybe someday! I'm worried we are already forgetting what happened and we are doomed to repeat all the mistakes in the future when the next pandemic hits.
More generally I think there is a lot of room for regulatory reform at the FDA which can increase innovation and speed the delivery of treatments to patients while maintaining rigorous safety testing and the generation of rigorous efficacy data.
Part of the problem is the FDA is a "sacred cow" many people in biotech and medicine are afraid to criticize.
Many of the biggest problems are also non-obvious (people have a blind spot for opportunity cost.. and there's a reason the "invisible graveyard" is invisible). Economists have been talking about these issues for decades but who reads dense and technical economics papers other than economists?
It's easy to be cast off as libertarian ideologue when you criticize the FDA, also. I've been careful to stress I'm not calling for libertarian deregulation of all things, but it's easy to be branded that way.
Wow ... deserves a lot more attention. Thanks for posting
I found this very insightful! By now, I have heard people rage about the FDA so many times but still don’t have great clarity on what exactly makes (parts of it) so terrible.
Also I would like to learn more about the differences between Europe and the US in device and drug approval processes.
You have written about the FDA multiple times. What makes you personally so interested in this topic?
I got interested in Feb 2021 when trying to figure out why the AstraZeneca vaccine hadn't been authorized in the US when there was really good Phase III trial data to support it and it had been authorized in the UK at the end of December.
It led me down a rabbit hole where I was reading the FDA critiques of Alex Tabarrok and others.
In early spring 2021 1000s of people were dying daily from COVID and there was a shortage of vaccine (many who wanted one couldn't get one). We had thousands of doses of AstraZeneca sitting in a warehouse in Baltimore. There was an incredible sense of urgency (https://marginalrevolution.com/marginalrevolution/2021/01/approve-the-astrazeneca-vaccine-now.html)
I organized this YouTube panel: https://www.youtube.com/watch?v=QL4q9gPlGAY
And also this protest outside the FDA:
https://twitter.com/moreisdifferent/status/1361042268841529347?s=20
For a summary of the devastation wrought by the FDA during the pandemic check out this post and some of the links therein: https://marginalrevolution.com/marginalrevolution/2021/03/fda-postpones-inspections-delaying-new-drugs-and-creating-shortages-of-old-drugs.html
I have been meaning to do a blog post summarizing all the things that went wrong at the FDA during the pandemic and calling for a congressional inquiry. Maybe someday! I'm worried we are already forgetting what happened and we are doomed to repeat all the mistakes in the future when the next pandemic hits.
More generally I think there is a lot of room for regulatory reform at the FDA which can increase innovation and speed the delivery of treatments to patients while maintaining rigorous safety testing and the generation of rigorous efficacy data.
Part of the problem is the FDA is a "sacred cow" many people in biotech and medicine are afraid to criticize.
Many of the biggest problems are also non-obvious (people have a blind spot for opportunity cost.. and there's a reason the "invisible graveyard" is invisible). Economists have been talking about these issues for decades but who reads dense and technical economics papers other than economists?
It's easy to be cast off as libertarian ideologue when you criticize the FDA, also. I've been careful to stress I'm not calling for libertarian deregulation of all things, but it's easy to be branded that way.