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Unpopular opinion: the FDA has to justify their existence. If vaccines can be developed safely and deployed quickly, inexpensively, and in large quantities all

Unpopular opinion: the FDA has to justify their existence. If vaccines can be developed safely and deployed quickly, inexpensively, and in large quantities all without FDA then people would realize how bloated our government really is.

Traster 6y ago
We saw this with Boeing - as the private company realised that the regulatory body wasn't going to hold it accountable, the private company started trading off profit versus safety with the result being lower short term costs and more dangerous planes.
happytoexplain 6y ago
>If vaccines can be developed safely ... without FDA You forgot a critical distinction: safely every time
- Jtsummers 6y ago
  Doesn't need to be every time, it "just" needs to meet or beat the current FDA record. The FDA has approved treatments in the past that turned out to be harmful for substantial numbers of people. If the industry could reliably replicate the FDA's present track record (which is, overall, very good) then the FDA could be shown to be unnecessary. However, having worked in regulated industries I do not trust industry to do any better than the FDA. At least not in the long term.
joncrane 6y ago
I think this is a bit of a disingenuous approach. There's a slippery slope here. Just because "humanity, including giant healthcare conglomerates who stood to profit came together to fast track vaccines against a deadly global pandemic" it doesn't mean "regulation of the vaccine and drug industry is pointless." If the FDA were to relax its standards across the board due to this one success in the face of an anomaly, you'd better believe drug manufacturers would be fast tracking dangerous drugs. Heck even in the current regulatory environment dangerous products make it through. As evidenced by all the ads I see for litigation based on harm caused by various already-approved (in a non-fast track manner) drugs that have made it to the market in the last decade.
FuckButtons 6y ago
The reason this is unpopular is because of how obviously incorrect it is. The history of medicine is almost an allegory for why evolved evidence based systems like this to regulate what companies and doctors can do. Time and again, doctors and pharmaceutical companies have done unsafe, harmful and fraudulent things to patients who trusted them. The only reason we have medicine that works now is because we rigorously enforce the use of statistical proof that interventions work through bodies like the FDA.
- cogman10 6y ago
  Yup. There's a lot of distrust in doctors and the medical community and some of that has been earned by past lapses in ethics or rigor. The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence. Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?
- abfan1127 6y ago
  I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to keep the information light or the FDA would be easily confused and reject. Rejection had more to do with giving the FDA simple warm fuzzies rather than rigorous data analysis. The FDA process is more an exercise in paperwork, not in rigorous drug/device performance. As you say, doctors and pharma have done unsafe, harmful, and fraudulent things to patients. How much was the FDA complacent in this? All of these drugs were approved by the FDA's "process". https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls https://www.fda.gov/drugs/drug-safety-and-availability/drug-...
  - sterlind 6y ago
    Drugs are much more rigorously evaluated than medical devices. It's just a quirk of the FDA that medical devices aren't nearly as well regulated or tested.
tootie 6y ago
Safe, effective vaccines are being developed because they know if they don't they won't get past the FDA.
raverbashing 6y ago
The 737 Max would like a word
malux85 6y ago
There's always going to be work for the FDA, there's an unending stream of new diseases/conditions and cures. I very much doubt they are worried about running out of work
klodolph 6y ago
The FDA more than justified its existence when it prevented the entry of thalidomide into the US market without more evidence of its safety. https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide
- JamesBarney 6y ago
  How many people have died from drugs getting approved later or not being able to afford drugs due to the high price of drug testing? Or from drugs not being researched or approved because it's too expensive to do an fda trial?
pfarnsworth 6y ago
This is unfortunately an ignorant statement. During the Swine Flu epidemic, British health care workers were given an untested vaccine. It left many of them with lingering health problems like narcolepsy. This is what happens when things are unsafely and quickly distributed.

Traster 6y ago

We saw this with Boeing - as the private company realised that the regulatory body wasn't going to hold it accountable, the private company started trading off profit versus safety with the result being lower short term costs and more dangerous planes.

happytoexplain 6y ago

>If vaccines can be developed safely ... without FDA You forgot a critical distinction: safely every time

Jtsummers 6y ago
Doesn't need to be every time, it "just" needs to meet or beat the current FDA record. The FDA has approved treatments in the past that turned out to be harmful for substantial numbers of people. If the industry could reliably replicate the FDA's present track record (which is, overall, very good) then the FDA could be shown to be unnecessary. However, having worked in regulated industries I do not trust industry to do any better than the FDA. At least not in the long term.

joncrane 6y ago

I think this is a bit of a disingenuous approach. There's a slippery slope here. Just because "humanity, including giant healthcare conglomerates who stood to profit came together to fast track vaccines against a deadly global pandemic" it doesn't mean "regulation of the vaccine and drug industry is pointless." If the FDA were to relax its standards across the board due to this one success in the face of an anomaly, you'd better believe drug manufacturers would be fast tracking dangerous drugs. Heck even in the current regulatory environment dangerous products make it through. As evidenced by all the ads I see for litigation based on harm caused by various already-approved (in a non-fast track manner) drugs that have made it to the market in the last decade.

FuckButtons 6y ago

The reason this is unpopular is because of how obviously incorrect it is. The history of medicine is almost an allegory for why evolved evidence based systems like this to regulate what companies and doctors can do. Time and again, doctors and pharmaceutical companies have done unsafe, harmful and fraudulent things to patients who trusted them. The only reason we have medicine that works now is because we rigorously enforce the use of statistical proof that interventions work through bodies like the FDA.

cogman10 6y ago
Yup. There's a lot of distrust in doctors and the medical community and some of that has been earned by past lapses in ethics or rigor. The only way to earn it back is by heightened scrutiny. That's the role the FDA finds itself in. It doesn't just approve things because approving something that later causes issues will ultimately result lost confidence. Getting people to take these vaccines will be a challenge in and of itself. Can you imagine how much harder it will be if we give antivaxxers more "they rushed this" ammunition?
abfan1127 6y ago
I spent time at a large medical device company. I'm lightly familiar with the FDA submission process. I would not refer to it as rigorous. We were encouraged to keep the information light or the FDA would be easily confused and reject. Rejection had more to do with giving the FDA simple warm fuzzies rather than rigorous data analysis. The FDA process is more an exercise in paperwork, not in rigorous drug/device performance. As you say, doctors and pharma have done unsafe, harmful, and fraudulent things to patients. How much was the FDA complacent in this? All of these drugs were approved by the FDA's "process". https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls https://www.fda.gov/drugs/drug-safety-and-availability/drug-...
- sterlind 6y ago
  Drugs are much more rigorously evaluated than medical devices. It's just a quirk of the FDA that medical devices aren't nearly as well regulated or tested.

tootie 6y ago

Safe, effective vaccines are being developed because they know if they don't they won't get past the FDA.

raverbashing 6y ago

The 737 Max would like a word

malux85 6y ago

There's always going to be work for the FDA, there's an unending stream of new diseases/conditions and cures. I very much doubt they are worried about running out of work

klodolph 6y ago

The FDA more than justified its existence when it prevented the entry of thalidomide into the US market without more evidence of its safety. https://en.wikipedia.org/wiki/Thalidomide https://en.wikipedia.org/wiki/Thalidomide

JamesBarney 6y ago
How many people have died from drugs getting approved later or not being able to afford drugs due to the high price of drug testing? Or from drugs not being researched or approved because it's too expensive to do an fda trial?

pfarnsworth 6y ago

This is unfortunately an ignorant statement. During the Swine Flu epidemic, British health care workers were given an untested vaccine. It left many of them with lingering health problems like narcolepsy. This is what happens when things are unsafely and quickly distributed.