This is exactly the type of behavior that gives people legitimate, reasonable arguments for not trusting the government. I’m pro-vaccine and I’m super-rankled by this nonsense. Also, I regularly review 500+ pages of discovery for redaction and disclosure, alone, over 3-4 days, while still working full-time… I’m pretty sure the federal government could figure out how to work a skosh faster.
This is a good data point, and it does point to wanting to limit liability, at your rate you could process 5000 pages a month, bringing the time down to 7 years instead of 72...
Throw 6 people at it, throw in review processes, maybe you could get it done in a couple years. Say 5 to hedge.
The issue stems from the number of total pages (329,000) and the proposed record release schedule of 500 pages per month
"FDA proposes to process and
produce the non-exempt portions of responsive records at a rate of 500 pages per month. This rate
is consistent with processing schedules entered by courts across the country in FOIA cases"
"FDA’s proposed schedule of 500 pages per month is consistent with
schedules set by courts across the country, including in cases where the underlying records were
of national significance"
"The FDA has proposed to produce 500 pages per month which, based on its calculated
number of pages, would mean it would complete its production in nearly 55 years – the year 2076. "
To me this seems like it is more about bureaucracy rather than maliciousness. And in my view a fair criticism of the slow pace that FOIA documents are released.
Imho the relevant thing here is that if this is allowed to stand, by inflating the size of data the goverment can effectively hide any data it wants and block the public from accessing it while retaining a veil of "nothing wrong done here".
Additionally I would say that foi requests are generally fulfilled more by document categorisation than by page, especially if the case is not about military secrets where much more careful screening might be required.
My first thought is that there are 329,000 pages of data related to the Pfizer vaccine alone and we are supposed to believe that the FDA read and evaluated them before granting authorization.
I guess the data exists in digital format, because no human reads 329,000 pages of such a report. If it is data, it muss be electronically processed just as it was electronically gathered in the first place. Inefficient bureaucracy isn't really a sensible excuse. You could hide any data with stuffed documents like taht.
The 500 pages per month rule may have made sense back when everything was actually on paper. But these days, just one DVD or flash drive could hold all 329,000 pages. I'm guessing that it's actually more work for them to split the release into 500-page segments than it would be to release them all at once, so I'm inclined to assume they're intentionally going at the slowest allowed rate because there's information in there that they'd rather keep to themselves forever.
> The 500 pages per month rule may have made sense back when everything was actually on paper
It has nothing to do with medium, it has to do with review of mixed material for information that is not subject to FOIA (personal privacy, trade secret, confidential commercial data, and other legally protected information) and avoiding the requirement for that review being a mechanism for using FOIA as a denial-of-service attack on federal agencies.
> But these days, just one DVD or flash drive could hold all 329,000 pages.
Which doesn't materially impact the workload of reviewing it prior to release.
> The 500 pages per month rule may have made sense back when everything was actually on paper. But these days, just one DVD or flash drive could hold all 329,000 pages.
I doubt "copying" is the actual bottleneck. It's totally doable to photocopy 500 pages in an hour (if you have a document feeder). What they're talking about is probably more the manual work to search, evaluate material for appropriateness to release, etc.
The issue is that the requester is asking for 329000 pages, and courts apparently previously ruled that a rate of 500 pages/month is reasonable for freedom of information requests.
And looks like more narrow requests for documents would be completed faster:
"If Plaintiff decides to request fewer records, then FDA will be able to complete its processing at an earlier
date."
But shouldn't requests like this complete still in a timely matter? If the government uses data that is under freedom of information but effectively doesn't allow people to go over the data, isn't that perversion of the idea of freedom of information?
An alternative is of course that we would treat requests by multiple people as more important, for example, if we assume that 1000 people requested these documents it would only take less than a month, but imho that's a huge slippery slope where information can effectively be hidden by inflating the size of it.
Having done an FDA submission myself I am actually amazed at how short this time period would be.
In the Old Days, to file an NDA required special arrangements with printing companies who could handle such a job and a team who arranged for the fleet of trucks required to deliver the submissions.
Edit: NDA = New Drug Application which includes, among other things, basically all your raw data which includes hordes of PII.
TBF it also includes a lot of boring in vitro data and analysis, preclinical (animal and in vitro) data etc which will have minimal to no PII.
I’d recommend reading the original documents associated with the lawsuit (No. 4:21-cv-01058-P) instead of the article linked in this post.
Some notable excerpts:
> Plaintiff seeks the records submitted to the FDA by Pfizer to license its COVID-19 vaccine (the “FOIA request”) and requests an order requiring the FDA to produce all documents responsive to its FOIA request no later than March 3, 2022. This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s Covid-19 vaccine.
> Plaintiff is an organization comprised of over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, and Brown.
> The ability of a majority of Americans to participate in civil society, and even exercise basic liberty rights, are now contingent on receiving this product. For example, the White House’s recent Covid-19 Action Plan and executive orders have made receipt of this product a condition of employment for more than 6 million federal workers and contractors, 22 million healthcare professionals, 84 million private sector employees, and the enlisted and reserve members of our armed forces. There are few whose livelihood, education, service, and participation in civil society are not contingent on a government requirement to receive this product. On this basis alone, basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available to Plaintiff and the public forthwith, precisely as contemplated by federal regulations.
> The acute need for transparency regarding this product is heightened by the fact that the secretary of Health and Human Services (“HHS”), the FDA’s parent department, has granted Pfizer complete immunity from financial liability for any injury caused by its product.
> It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021,14 to when the product was licensed on August 23, 2021.15 We assume, as the FDA has stated, that it conducted an intense, robust, thorough and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. The FDA now has an equally important task of making those documents available to the Plaintiff in this case and the public at large in at least the same timeframe.
The FDA’s own regulations envision and reflect upon the importance of making this information public as soon as a vaccine is licensed. Its regulations provide that it is to make “immediately available” all documents underlying licensure of a vaccine. 21 C.F.R. § 601.51(e). The FDA knew the intense public interest in that data and information. It should have been preparing to release it simultaneously with the licensure. Instead, it has done the opposite. Despite the passage of 84 days since licensure and 192 days since Pfizer started producing the records for licensure, the FDA has not released a single document submitted by Pfizer for the licensure of its Covid-19 vaccine. Not one page.
I’m not a lawyer but the complaint seems perfectly reasonable.
This submission was flagged once already but then cleared. The feedback was that linking to the actual document might in some instances be ok but then a good comment on why the document is interesting would be needed.
I believe that with your comment linking to the actual document would be ok.
Due to title length limit I had to shorten the title a little, original at the moment of submission was: "FDA Asks Federal Judge to Grant it Until the Year 2076 to Fully Release Pfizer’s COVID-19 Vaccine Data"
According to this guardian report aaron siri is connected to a the Texas anti-vaxxer group Ican (Informed Consent Action Network). They probably understands this is what they get from a government agency like FDA when asking for the data and it gives them ammunition.
https://www.theguardian.com/us-news/2021/jun/22/anti-vax-gro...
Out of curiosity, do we think there is there anything another branch of the government could do to alter such a decision, if made, & if higher courts don't take this up?
I'm not here to burst any bubbles, but scrolling through this guy's substack history it would appear he's got a little more than just a passing interest in the topic of vaccine legitimacy. Of course, it's nice seeing people talk about legal discrepancies in the US, but at this point it's more of an inevitability than a surprise. Once you factor in personal beliefs, it can be a little hard to differentiate between the wheat and the chaff.
I don't really care what his interests are or if he is head of the National Antivaxxer Association. If what he is saying is true, it's a massive problem.
[+] [-] Fezzik|4 years ago|reply
[+] [-] bitsnbytes|4 years ago|reply
The general public rightfully has a very low trust of the gov't and this certainly adds more validity to their distrust.
[+] [-] HenryKissinger|4 years ago|reply
[+] [-] smaudet|4 years ago|reply
Throw 6 people at it, throw in review processes, maybe you could get it done in a couple years. Say 5 to hedge.
[+] [-] skunkworker|4 years ago|reply
The issue stems from the number of total pages (329,000) and the proposed record release schedule of 500 pages per month
"FDA proposes to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month. This rate is consistent with processing schedules entered by courts across the country in FOIA cases"
"FDA’s proposed schedule of 500 pages per month is consistent with schedules set by courts across the country, including in cases where the underlying records were of national significance"
"The FDA has proposed to produce 500 pages per month which, based on its calculated number of pages, would mean it would complete its production in nearly 55 years – the year 2076. "
To me this seems like it is more about bureaucracy rather than maliciousness. And in my view a fair criticism of the slow pace that FOIA documents are released.
[+] [-] emilfihlman|4 years ago|reply
Additionally I would say that foi requests are generally fulfilled more by document categorisation than by page, especially if the case is not about military secrets where much more careful screening might be required.
[+] [-] lborsato|4 years ago|reply
[+] [-] raxxorrax|4 years ago|reply
[+] [-] unknown|4 years ago|reply
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[+] [-] josephcsible|4 years ago|reply
[+] [-] dragonwriter|4 years ago|reply
It has nothing to do with medium, it has to do with review of mixed material for information that is not subject to FOIA (personal privacy, trade secret, confidential commercial data, and other legally protected information) and avoiding the requirement for that review being a mechanism for using FOIA as a denial-of-service attack on federal agencies.
> But these days, just one DVD or flash drive could hold all 329,000 pages.
Which doesn't materially impact the workload of reviewing it prior to release.
[+] [-] tablespoon|4 years ago|reply
I doubt "copying" is the actual bottleneck. It's totally doable to photocopy 500 pages in an hour (if you have a document feeder). What they're talking about is probably more the manual work to search, evaluate material for appropriateness to release, etc.
[+] [-] dklsf|4 years ago|reply
And looks like more narrow requests for documents would be completed faster: "If Plaintiff decides to request fewer records, then FDA will be able to complete its processing at an earlier date."
[+] [-] emilfihlman|4 years ago|reply
An alternative is of course that we would treat requests by multiple people as more important, for example, if we assume that 1000 people requested these documents it would only take less than a month, but imho that's a huge slippery slope where information can effectively be hidden by inflating the size of it.
[+] [-] gumby|4 years ago|reply
In the Old Days, to file an NDA required special arrangements with printing companies who could handle such a job and a team who arranged for the fleet of trucks required to deliver the submissions.
Edit: NDA = New Drug Application which includes, among other things, basically all your raw data which includes hordes of PII.
TBF it also includes a lot of boring in vitro data and analysis, preclinical (animal and in vitro) data etc which will have minimal to no PII.
[+] [-] l8rpeace|4 years ago|reply
[+] [-] imnotreallynew|4 years ago|reply
Some notable excerpts:
> Plaintiff seeks the records submitted to the FDA by Pfizer to license its COVID-19 vaccine (the “FOIA request”) and requests an order requiring the FDA to produce all documents responsive to its FOIA request no later than March 3, 2022. This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s Covid-19 vaccine.
> Plaintiff is an organization comprised of over 30 accomplished academics, professors, and scientists from the medical schools and related departments of our most prestigious universities, including Yale, Harvard, UCLA, and Brown.
> The ability of a majority of Americans to participate in civil society, and even exercise basic liberty rights, are now contingent on receiving this product. For example, the White House’s recent Covid-19 Action Plan and executive orders have made receipt of this product a condition of employment for more than 6 million federal workers and contractors, 22 million healthcare professionals, 84 million private sector employees, and the enlisted and reserve members of our armed forces. There are few whose livelihood, education, service, and participation in civil society are not contingent on a government requirement to receive this product. On this basis alone, basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available to Plaintiff and the public forthwith, precisely as contemplated by federal regulations.
> The acute need for transparency regarding this product is heightened by the fact that the secretary of Health and Human Services (“HHS”), the FDA’s parent department, has granted Pfizer complete immunity from financial liability for any injury caused by its product.
> It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021,14 to when the product was licensed on August 23, 2021.15 We assume, as the FDA has stated, that it conducted an intense, robust, thorough and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. The FDA now has an equally important task of making those documents available to the Plaintiff in this case and the public at large in at least the same timeframe. The FDA’s own regulations envision and reflect upon the importance of making this information public as soon as a vaccine is licensed. Its regulations provide that it is to make “immediately available” all documents underlying licensure of a vaccine. 21 C.F.R. § 601.51(e). The FDA knew the intense public interest in that data and information. It should have been preparing to release it simultaneously with the licensure. Instead, it has done the opposite. Despite the passage of 84 days since licensure and 192 days since Pfizer started producing the records for licensure, the FDA has not released a single document submitted by Pfizer for the licensure of its Covid-19 vaccine. Not one page.
I’m not a lawyer but the complaint seems perfectly reasonable.
[+] [-] emilfihlman|4 years ago|reply
This submission was flagged once already but then cleared. The feedback was that linking to the actual document might in some instances be ok but then a good comment on why the document is interesting would be needed.
I believe that with your comment linking to the actual document would be ok.
[+] [-] TifMorgan|4 years ago|reply
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[+] [-] qwertyuiop_|4 years ago|reply
[+] [-] emilfihlman|4 years ago|reply
[+] [-] gallego2007|4 years ago|reply
[+] [-] unknown|4 years ago|reply
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[+] [-] azsrz|4 years ago|reply
[+] [-] yehosef|4 years ago|reply
[+] [-] brjsuitor|4 years ago|reply
No need. It’s all right here. Google everything so far simian virus mouse sarcoma mouse hepatitis cytomegalovirus retrovirus
[+] [-] brjsuitor|4 years ago|reply
[+] [-] rektide|4 years ago|reply
[+] [-] landemva|4 years ago|reply
[+] [-] smoldesu|4 years ago|reply
[+] [-] dolni|4 years ago|reply
[+] [-] azsrz|4 years ago|reply
[+] [-] theduder99|4 years ago|reply
[+] [-] sebow|4 years ago|reply
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[+] [-] neildavid|4 years ago|reply
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