
The FDA's perpetual process machine - jseliger
https://paulromer.net/fda_perpetual_process_machine/
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seehafer
There are number of conflated regulatory problems in this piece:

1) FDA needs to move its data ingestion into the 21st century (note: large
industry can be as resistant to changing current process as bureaucracy). In
no rational universe should we have to mail data in 2020

2) In vitro diagnostic regulation is a mess and needs to be revamped top to
bottom. Either exempt all Lab Developed Tests, rewrite the law to make them
all subject to oversight, or come up with a 3rd path.

3) Emergency Use Authorization needs to be rethought with the ability for
either political leadership or FDA to have broad capability to expand the
category of what gets covered

~~~
jazzkingrt
I don't think "conflated" is the right word. Romer doesn't imply that these
problems have the same cause, or are even correlated (although I suspect they
are).

He just lays them out as stark examples of FDA getting in the way of the
public interest in this pandemic.

~~~
seehafer
That's a fair point. I was responding to this idea of all of these being part
of a single "process machine".

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causality0
The sorry state of the FDA and drug development and deployment as a whole is
in my opinion due to a preponderance of two types of people: Type A will
happily bankrupt their customers while giving them heart failure in order to
reduce allergy symptoms by 10%, and Type B would rather let ten thousand
people die in unmedicated screaming agony than have a drug show up in a news
story saying it killed three of them, regardless of how many hundreds of lives
it saved.

~~~
jschwartzi
The FDA is largely composed of Type B people. They are very risk averse and
will often delay a new technology simply because there might be unknown risks.
There are technologies widely used in European ventilators such as automatic
alarm control or adaptive alarm limits which the FDA views as unsafe based on
their fear that the alarm system might fail somehow.

It doesn’t surprise me that they tried to slow the approval process down.
Anyone that believes the FDAs mandate is to foster progress is severely
misinformed. Their actual mandate as I understand it is specifically to
protect the public from injury by making progress really slow and making sure
there are enough barriers to prevent someone selling a product which makes
patients worse off than competitors.

In this case they probably caused a lot more damage than they prevented.

~~~
refurb
I work with the FDA as a part of my job and I disagree they are overly risk
adverse. When we previewed our development plan with the FDA, they actually
asked us "can't you move faster?". When a safety signal showed up, they were
more than willing to work with us to develop a protocol to reduce the risk
while still providing patients with drugs.

I don't disagree that the FDA is very concerned about safety, but in
situations where there is a very strong need, the FDA is willing to move
quickly and accept a level of risk.

~~~
gwern
It's nice that they offered to slightly tweak the protocol for you. How very
generous and magnanimous of them.

On the other hand: coronavirus.

~~~
refurb
I honestly don't think it's fair to crap all over the FDA for Covid. One day
we read that people become immune, the next day they lose it. One day
hydroxychloroquine works, then next day it doesn't.

It's hard enough managing drug approvals when you have all the data and plenty
of time.

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projektfu
I still don’t understand why the FDA was telling labs not to develop their own
tests. After publication of the primers, it’s standard work to create an
rtPCR. And being a lab developed test it should be out of the jurisdiction of
the FDA.

~~~
James_Henry
If I recall correctly, it is due to the declaration of a state of emergency.
Usually only a lab would need certification, but the emergency made it
necessary for every test to be certified. Don't quote me on this though, I'll
try and find a source.

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chmaynard
Unfortunately, we need to be skeptical about almost every decision and
communication from the CDC, FDA, and a number of other federal agencies. The
current administration has done a remarkably effective job of bending these
agencies to their will and forcing out anyone who doesn't fall in line.

~~~
wonnage
I think this is one of the great side tragedies of the coronavirus. The US
generally had a lot of trust in these federal agencies. They've always been
susceptible to political interference, as demonstrated now. But it's never (?)
gotten to the point it has now, where you simply can't trust the CDC to
provide accurate information, or information that every other country has
accepted months ago.

Will the next administration provide a V-shaped recovery in trust? Or is it
just gone forever?

~~~
tridentlead
It's not the administration. It's just the general ineptitude of many
government processes. The current crisis has just laid inadequacies bare.

~~~
throw-away_42
It is this Republican administration. They were left a playbook for this
scenario. They threw it out, and then lied about it.

[https://www.mercurynews.com/2020/05/12/fact-check-obama-
left...](https://www.mercurynews.com/2020/05/12/fact-check-obama-left-trump-a-
pandemic-response-playbook/)

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LatteLazy
I find this interesting as the FDA basically fell over themselves to sign off
in treatments. They gave chloroquine the ok based on less than nothing and
other drugs have been given breakthrough treatment status without trials.

I can see an arguement to "try anything" in an emergency. But how did the fda
end up being BOTH to lose and too tight with their regulation?

~~~
beagle3
Chloroquine and hyrdorchloroquine have been in use for decades (70 years for
chloroquine!) with millions taking them daily and a very well known safety
profile. It was already FDA approved, could have been used by any doctor for
COVID as an off-label treatment already. Everything about CQ/HCQ has been
ridiculously politicized to the point that the facts have become very hard to
find.

In fact, given the huge number of people taking them for lupus and other
diseases (a significant fraction of a percent of the population, having
autoimmune disorders and poor health and thus at greater COVID risk), we've
basically had a biased but ultra-informative experiemnt already: What
percentage of them got covid and what severity, as compared to general
population, and compared to other comparable populations (autoimmune that
isn't treated by CQ/HCQ)? It's not perfect, but it would have been very
informative. CDC _has_ this info. No ethical issues about it.

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killjoywashere
The main economic function of employees of agencies in DC is the transfer of
risk away from the DC housing market, onto the American people. The career
employees of the military, as a particularly extreme example, exist to
transfer risk away from the DC housing market as far away as possible, which
ultimately ends with special forces personnel deployed to hostile territory.

Similarly, the main economic function of employees of big tech companies is
transferring risk away from the West Coast housing markets, onto their users.

In my experience, the only way to handle the government side of this is to
"not waste the crisis" and execute under conditions where they will see
stopping you as more risky than not stopping you.

The only way I know of to manage large corporations is to get the government
to create incentives that make it riskier for them to transfer risk onto their
customers. That's what financial penalities and anti-trust law are for. The
trick is you have to go back to the point about the government: you have to
make action less risky for the government actors than non-action.

