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FDA Asks the Court to Delay First 55,000 Page Production Until May (1 Viewer)

LawFitz

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FDA Asks the Court to Delay First 55,000 Page Production Until May and Pfizer Moves to Intervene in the Lawsuit

- Aaron Siri

In a lawsuit seeking all of the documents the FDA relied upon to license Pfizer’s COVID-19 vaccine, a federal judge shot down the FDA’s requested rate of 500 pages per month and instead ordered the FDA to produce at the rate of 55,000 pages per month starting on March 1. 

Since the government has trillions of dollars of our money, it is putting it to good use by fighting to assure that the public has the least amount of transparency possible.  To that end, it has now asked the Court to make the public wait until May for it to start producing 55,000 pages per month and, even then, claims it may not be able to meet this rate. 

The FDA’s excuse?  As explained in the brief opposing the FDA’s request, the FDA’s defense effectively amounts to claiming that the 11 document reviewers it has already assigned and the 17 additional reviewers being onboarded are only capable of reading at the speed of preschoolers. ...

All of this insanity is simply in response to an attempt to obtain some basic transparency.  This should again bring into sharp focus why the government should never coerce or mandate anyone to get an unwanted medical product or procedure.  Just look at this circus – the government mandates Pfizer’s product, gives it immunity for any safety or efficacy issues, promotes its product using taxpayer money, gives Pfizer over $17 billion and then uses taxpayers’ money to fight to avoid providing even the most basic level of transparency to the public.
The FDA affirms it has already “allocated the equivalent of nearly 11 full-time staff to this project” and that “a review speed of 50 documents per hour was within the normal range for document review in a complex matter” in private practice; and here the 50 document per hour rate would be faster since there is only a need to review for personally identifying information (“PII”) for most pages.  Hence, if the FDA’s 11 full-time reviewers work only 7.5 hours per day and review 50 pages (not documents) per hour, the FDA could review over 88,000 pages per month in February and March.  That is more than sufficient to produce the 55,000 pages per month currently ordered for these two months. 

Instead of complying with this Court’s reasoned order, the FDA claims these 11 reviewers can only review a total of 10,000 pages per month.  What the FDA does not say, and what basic math shows, is that a rate of 10,000 pages a month for 11 full-time reviewers amounts to only 5 pages per hour!  This rate is made even more absurd because most of the pages the FDA will be reviewing during this period are repetitive data files that only require second level review to redact minimal amounts of PII that Pfizer may have left in the documents ... despite claiming it is making “unprecedented” efforts, the FDA repeatedly tells the Court: “It is not possible to guarantee that FDA will be able to fully comply” with the 55,000-page production rate thereafter.


WTF. Why are they SO adamant about not wanting to release the vaccine approval documents?!? How dare they take this stance. Why isn't every man and woman demanding this information NOW?!?

WHAT IS THE FDA HIDING??????

 
Conspiracy FACT - FDA doesn't want to release these documents.

Why not release them if there's nothing to hide?
Why would someone working an 8 hour day for the federal government put in 7.5 hours of document review?   Wouldn't that violate labor laws? 

Have you ever done a document review?  How long does it take you to review, say, 10,000 documents?

 
Why would someone working an 8 hour day for the federal government put in 7.5 hours of document review?   Wouldn't that violate labor laws? 

Have you ever done a document review?  How long does it take you to review, say, 10,000 documents?


Read the OP, buddy.

 
Read the OP, buddy.
I read it.  It's dumb.  Even with repetitive documents, an average person just can't do 7.5 hours (even if that was legal, which it's not) of review per day, every day.

Are the documents electronic?  Paper?  How are they organized?   Do you understand that when a document is redacted you need to separately log it, which also takes time?

The court was originally asking them to review 80,000 pages a month.   Now it's 55,000.   The request is for 450,000 pages of documents.  If I made a request like that, I'd expect the government to request a couple of years to respond.   They have 400 other requests that are also pending.

This is more of a non-story than the rest of your non-stories.

Swing and a miss again.

 
I read it.  It's dumb.  Even with repetitive documents, an average person just can't do 7.5 hours (even if that was legal, which it's not) of review per day, every day.

Are the documents electronic?  Paper?  How are they organized?   Do you understand that when a document is redacted you need to separately log it, which also takes time?

The court was originally asking them to review 80,000 pages a month.   Now it's 55,000.   The request is for 450,000 pages of documents.  If I made a request like that, I'd expect the government to request a couple of years to respond.   They have 400 other requests that are also pending.

This is more of a non-story than the rest of your non-stories.

Swing and a miss again.


Per the OP, which you say you read...

The FDA affirms it has already “allocated the equivalent of nearly 11 full-time staff to this project” and that “a review speed of 50 documents per hour was within the normal range for document review in a complex matter” in private practice

 
I agree with this rant. 

If you can't get it done with 11 reviewers, can you do it with 100?  Can we use automation?This is not an unsolvable problem.

 
Can we get FBGs to create a ‘Conspiracy’ sub-forum so things like this can be posted into one place? 
And believe it or not I was serious about this. The way you have it laid out this is definitely a conspiracy, no? 

 
Neat, another article from yet another conspiracy site devoted to discrediting vaccines.
It would be almost touching at this point if they and others weren't dying because of it. But the fealty to it...might be cute in other circumstances. 

 
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Unreal that 100% of us don't think it's utter bull#### and *extremely* sketchy that the FDA is fighting tooth and nail to avoid releasing these documents to the public. They want to wait 75 years to release them. 75! If you don't think that is beyond concerning, you should seriously check your own internal bias. 

Snap out of it, friends. Demand these answers. The FDA and Pfizer are not beyond your reproach. Not even close.

 
It would be almost touching at this point if they and others weren't dying because of it. But the fealty to it...might be cute in other circumstances. 


Touching? Cute?

Get over yourself. Seriously, I respect your intelligence very much, but you need to hear that. Your IQ and SAT scores don't make you as better than others as you very obviously believe.

 
He should. Get it all out.

Now what do you have to say about this FDA bull####?
Same.  The left is all about transparency and fairness.  That’s why they are getting their asses handed to them despite having an overwhelming majority of the voters leaning left.  

 
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This reminds me of the time James Comey was asked about the shenanigans at the FBI and he said it was nothing malicious, just incompetence. 

 
I agree with this rant. 

If you can't get it done with 11 reviewers, can you do it with 100?  Can we use automation?This is not an unsolvable problem.
Of course, the same people that complain about delays go ape#### when the government increases funding, and the corresponding taxation needed, to add services.

 
I agree with this rant. 

If you can't get it done with 11 reviewers, can you do it with 100?  Can we use automation?This is not an unsolvable problem.
Same.  It seems to me that this sort of stuff should be part of the public record.  Admittedly though, I'm not sure what the counter-argument even is, so I should probably apply Chesterton's fence here. 

Is it because Pfizer is worried about something proprietary coming out?  Well, tough.  If you want the government to enforce a monopoly for you, you need to meet us halfway, and transparency seems like a good place to start.  We can always look for remedies in IP law if that's the issue.  

 
Of course, the same people that complain about delays go ape#### when the government increases funding, and the corresponding taxation needed, to add services.
And the same people who are like "Government is just a word for things we do together" are quick to tell people to just lick the boot when they ask what exactly it is that we're doing together.

 
Same.  It seems to me that this sort of stuff should be part of the public record.  Admittedly though, I'm not sure what the counter-argument even is, so I should probably apply Chesterton's fence here. 

Is it because Pfizer is worried about something proprietary coming out?  Well, tough.  If you want the government to enforce a monopoly for you, you need to meet us halfway, and transparency seems like a good place to start.  We can always look for remedies in IP law if that's the issue.  


For those who want to see as many people vaccinated as possible expediting this should go right to the top of the things to do list...get out as much info as possible so those who have hesitations get more questions answered and hopefully are more comfortable with their decision...so often I see people on this board tout education or look down on people for not being educated well here is a perfect example for that to happen and any delays do far more harm than good because it is horrible optics. 

 
Everytime I think we have an issue we can all agree upon, I'm reminded how many people want the government to run their lives for them and will apologize for any mistake or transgression the government makes while doing it. It's like a battered spouse that keeps saying "Well he just had too much to drink, he's usually not like this."

It's absolutely ridiculous that we do not have complete transparency on something that was given to over 200m people in this country of all ages over the last 15 months. They originally tried to keep this under wraps until 2075 until they were forced to unveil it.  

 
Unreal that 100% of us don't think it's utter bull#### and *extremely* sketchy that the FDA is fighting tooth and nail to avoid releasing these documents to the public. They want to wait 75 years to release them. 75! If you don't think that is beyond concerning, you should seriously check your own internal bias. 

Snap out of it, friends. Demand these answers. The FDA and Pfizer are not beyond your reproach. Not even close.
What do you think the FDA and Pfizer's motives are?  Do you think they both align?  Is there some coverup of the major negative health impacts from the vaxxes going on...oh wait, we know there are not.  We know the vaccines have kept hundreds of thousands, if not millions, of people from getting hospitalized and dying.

There are plenty of places who will eat your fabricated conspiracy theories up, this place is not one of them.

 
Everytime I think we have an issue we can all agree upon, I'm reminded how many people want the government to run their lives for them and will apologize for any mistake or transgression the government makes while doing it. It's like a battered spouse that keeps saying "Well he just had too much to drink, he's usually not like this."

It's absolutely ridiculous that we do not have complete transparency on something that was given to over 200m people in this country of all ages over the last 15 months. They originally tried to keep this under wraps until 2075 until they were forced to unveil it.  
And you're not wrong at all.  And I'll bet all of us want there to be complete transparency and we of course don't want the government running our lives.  Such hyperbole is silly.

What we don't want is a known CT spreader like OP to glom onto some unrelated issue and try to wrap this into his fabricated "vaccines are harmful!!" conspiracy he's been peddling.  That's all.  If you have started the topic the responses would have been widely different I'll wager. 

 
Everytime I think we have an issue we can all agree upon, I'm reminded how many people want the government to run their lives for them and will apologize for any mistake or transgression the government makes while doing it. It's like a battered spouse that keeps saying "Well he just had too much to drink, he's usually not like this."

It's absolutely ridiculous that we do not have complete transparency on something that was given to over 200m people in this country of all ages over the last 15 months. They originally tried to keep this under wraps until 2075 until they were forced to unveil it.  
Confused here. Has anyone here stated they DON’T want this information released? If they have I haven’t seen it. 

What folks are saying is not everything is a big conspiracy. Government moves slow and there are not endless resources, etc. Things take time even in the best of times and the estimates put forth are what they thought with the staff at hand. 

Sure - add more people. Add 10 or 100 or even 1,000 - if that is what is needed hire away. 

 
Same.  It seems to me that this sort of stuff should be part of the public record.  Admittedly though, I'm not sure what the counter-argument even is, so I should probably apply Chesterton's fence here. 

Is it because Pfizer is worried about something proprietary coming out?  Well, tough.  If you want the government to enforce a monopoly for you, you need to meet us halfway, and transparency seems like a good place to start.  We can always look for remedies in IP law if that's the issue.  
from my 30 seconds of reading, I assume they need to review all documents to make sure there are no HIPPA violations - strip all identifiable information.

 
Same.  It seems to me that this sort of stuff should be part of the public record.  Admittedly though, I'm not sure what the counter-argument even is, so I should probably apply Chesterton's fence here. 

Is it because Pfizer is worried about something proprietary coming out?  Well, tough.  If you want the government to enforce a monopoly for you, you need to meet us halfway, and transparency seems like a good place to start.  We can always look for remedies in IP law if that's the issue.  


This is basically what I think. This info should be public. I'm willing to listen to a reason it should be concealed/delayed - but its got to be a good reason.

And I used to run doc reviews when I worked at a big firm. 55,000 pages is not particularly significant. A handful of first year lawyers can knock that out in a week.

 
WTF. Why are they SO adamant about not wanting to release the vaccine approval documents?!? How dare they take this stance. Why isn't every man and woman demanding this information NOW?!?

WHAT IS THE FDA HIDING??????


I trust the Federal Govt

I can reference how we treated native American's, how we treated Japanese American's in WWI/II .... how we treated blacks, and women. I mean what's not to trust ? 

and really, has the Fed Govt ever hid anything from American's ? or the FDA ?

wait ... I take all the above back. I don't trust any of them

 
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For those who want to see as many people vaccinated as possible expediting this should go right to the top of the things to do list...get out as much info as possible so those who have hesitations get more questions answered and hopefully are more comfortable with their decision...so often I see people on this board tout education or look down on people for not being educated well here is a perfect example for that to happen and any delays do far more harm than good because it is horrible optics. 
This won’t move the needle one bit. There is already an overwhelming amount of information out there. Nobody that is waiting on getting vaccinated is going to read a 55,000 page report and all it takes is a couple conspiracy theorists to find one or two things in those pages that they can take out of context, create an article with an all caps headline, and off it spreads through SM

 
IvanKaramazov said:
And the same people who are like "Government is just a word for things we do together" are quick to tell people to just lick the boot when they ask what exactly it is that we're doing together.
Exactly!   It should be much rarer for something to be classified a secret by the government of the people, for the people.  And that should never include IP.

ETA:  Well unless the information being redacted is information that violate the privacy of individuals and their health records.  

 
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James Daulton said:
And you're not wrong at all.  And I'll bet all of us want there to be complete transparency and we of course don't want the government running our lives.  Such hyperbole is silly.

What we don't want is a known CT spreader like OP to glom onto some unrelated issue and try to wrap this into his fabricated "vaccines are harmful!!" conspiracy he's been peddling.  That's all.  If you have started the topic the responses would have been widely different I'll wager
I retract this part of my statement.

 
Keep up the personal attacks. They've been working super well for you, dude.  :lol:
What about "I retract this part of my statement" represents a personal attack?  

Dude, you're peddling horrible science and conclusions based on some massive government cover up and conspiracy theory.  The rest of us just want to get through this pandemic and go back to living our lives.  Folks like you are making that more challenging because of the disinformation you put forward.

And you complain about personal attacks but have no problem saying "F Joe Biden" in many of your posts.

Apologies if you can't handle the truth. 

 
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What about "I retract this part of my statement" represents a personal attack?  

Dude, you're peddling horrible science and conclusions based on some massive government cover up and conspiracy theory.  The rest of us just want to get through this pandemic and go back to living our lives.  Folks like you are making that more challenging because of the disinformation you put forward.

And you complain about personal attacks but have no problem saying "F Joe Biden" in many of your posts.

Apologies if you can't handle the truth. 


Are you Joe Biden?  :lmao:

 
LawFitz said:
Touching? Cute?

Get over yourself. Seriously, I respect your intelligence very much, but you need to hear that. Your IQ and SAT scores don't make you as better than others as you very obviously believe.
I don't think my SAT scores make me brilliant at all. (They're quite low because I spent all of high school playing sports and ignoring academics, actually. The scores come later.)

But forget about how that informs my life. It's only a comparative measure, and nothing to do with brilliance or correctness about a subject. I've seen people with perfectly average scores and intelligence function very correctly because they're deferring in the right places. It's called "organizing the chaos" that is our modern world's information pipeline. Some people are great at it, others are not. I'm seeing really smart people fail this test, including people much smarter and with much better scores than I. Probably like you. 

I did bring up scores once back on this board in 2016 about something, and I won't do it again. It was gauche, and a red herring. And in support of Rand Paul over Donald Trump in the primary. You can check the thread. Lutherman2112 called me stupid, and I rebutted. But I was mainly upset about Trump back then because I can order the chaos and knew what would happen with him as president. Because ordering the chaos is sort of my friend because I know who and when to trust. 

Which I don't think you have a grip on yet. You ought defer to some authority at times. It can help you in this disinformation world. 

 
IvanKaramazov said:
Same.  It seems to me that this sort of stuff should be part of the public record.  Admittedly though, I'm not sure what the counter-argument even is, so I should probably apply Chesterton's fence here. 

Is it because Pfizer is worried about something proprietary coming out?  Well, tough.  If you want the government to enforce a monopoly for you, you need to meet us halfway, and transparency seems like a good place to start.  We can always look for remedies in IP law if that's the issue.  
you realize this isn't Pfizer at all, right?  The FDA is being asked to produce, and is producing, 450,000 documents on an expedited basis.

this is one FOIA request out of 400 pending requests.

there is no story here.

 
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