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FDA Asks Court for 55 Years to Fully Release Pfizer Vaccine Data
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Last: 2 yr ago by shovel pass
Epoch Times . . . did not read.
there is ONE reason and ONE reason only they would want to do this. they dont want the public to know what's going on with these vaccines.. everyone should be very scared seeing this. The FDA should not be protecting Pfizer on this yet they are.baron_von_awesome said:
https://www.theepochtimes.com/fda-asks-court-for-55-years-to-fully-release-pfizer-covid-19-vaccine-data_4110761.html
Why do this?
"WHAT ARE THEY TRYING TO HIDE"
should be the question every single one of us is asking...
Here's the filing.
https://www.sirillp.com/wp-content/uploads/2021/11/020-Second-Joint-Status-Report-8989f1fed17e2d919391d8df1978006e.pdf
Very misleading headline:
https://www.sirillp.com/wp-content/uploads/2021/11/020-Second-Joint-Status-Report-8989f1fed17e2d919391d8df1978006e.pdf
Very misleading headline:
They are saying if they just agree to what the FDA will provide, 500 pages a month, it would take 55 years to see all of it. The healthcare officials are suing to get more information sooner, not FDA asking to hide it for 55 years.Quote:
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. If injured
-- including suffering one of the injuries even federal health authorities admit occur from Pfizer's
product -- the injured individual effectively has no recourse. Pursuant to the declaration from the
secretary of HHS, Pfizer cannot be sued by anyone receiving this product for any injury. 42 U.S.C.
247d-6d. Pfizer also cannot be sued for willful misconduct regarding this product unless HHS,
which has been promoting this product, agrees to bring such a claim. 42 U.S.C. 247d-6d(c)(5).
13
It should not be that the public is deprived accessing the documents and data submitted by Pfizer
to license this product when at the same time the public are being mandated to receive this product
with no ability to sue Pfizer for compensation if they suffer any adverse reaction.
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.
Until the entire body of documents provided by Pfizer to the FDA are made available, an
13 Reports have recently surfaced that the FDA was aware of concerns about unsound practices in connection with
clinical trials for the Pfizer Vaccine, but that FDA failed to properly investigate these claims.
appropriate analysis by the independent scientists that are members of Plaintiff is not possible.
Would the FDA agree to review and license this product without all the documents? Of course
not. These independent, world-renowned scientists should be provided the same forthwith.
My pronouns are AFUERA/AHORA!
it's not misleading. If the FDA was able to approve it in less than a year, then it shouldn't take 55 years to produce documentation on that approval.BadMoonRisin said:
Here's the filing.
https://www.sirillp.com/wp-content/uploads/2021/11/020-Second-Joint-Status-Report-8989f1fed17e2d919391d8df1978006e.pdf
Very misleading headline:They are saying if they just agree to what the FDA will provide, 500 pages a month, it would take 55 years to see all of it. The healthcare officials are suing to get more information sooner, not FDA asking to hide it for 55 years.Quote:
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. If injured
-- including suffering one of the injuries even federal health authorities admit occur from Pfizer's
product -- the injured individual effectively has no recourse. Pursuant to the declaration from the
secretary of HHS, Pfizer cannot be sued by anyone receiving this product for any injury. 42 U.S.C.
247d-6d. Pfizer also cannot be sued for willful misconduct regarding this product unless HHS,
which has been promoting this product, agrees to bring such a claim. 42 U.S.C. 247d-6d(c)(5).
13
It should not be that the public is deprived accessing the documents and data submitted by Pfizer
to license this product when at the same time the public are being mandated to receive this product
with no ability to sue Pfizer for compensation if they suffer any adverse reaction.
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.
Until the entire body of documents provided by Pfizer to the FDA are made available, an
13 Reports have recently surfaced that the FDA was aware of concerns about unsound practices in connection with
clinical trials for the Pfizer Vaccine, but that FDA failed to properly investigate these claims.
appropriate analysis by the independent scientists that are members of Plaintiff is not possible.
Would the FDA agree to review and license this product without all the documents? Of course
not. These independent, world-renowned scientists should be provided the same forthwith.
Creating something at a rate of 27,500 pages a month to get total immunity from lawsuits, but only releasing copies at a rate of 500 in the name of transparency, is deliberately slow playing the full release for 55 years.
Per the filing...
"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."
"Plaintiff's request (as set forth below) that FDA process and produce the non-exempt portions of more than 329,000 pages in four months would force FDA to process more than 80,000 pages per month. Undersigned counsel is not aware of any court ever granting such a request."
Also worth noting...
The plaintiff, Public Health and Medical Professionals for Transparency (PHMPT), is a group of doctors and scientists, including Harvey Risch, a professor of epidemiology at the Yale School of Public Health.
The way I read it, the PHMPT is asking for something that may not be possible given what the FDA has to go through to provide the documents. The filing lists the reasons why the FDA says it cannot meet the requested timeline. Go read those reasons on pages 4-8 of the filing.
Not sure how this turned into the claims that the FDA must be hiding something? I'm sure everyone complaining read through the filing first right? Or did they just read the twitter outrage?
"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."
"Plaintiff's request (as set forth below) that FDA process and produce the non-exempt portions of more than 329,000 pages in four months would force FDA to process more than 80,000 pages per month. Undersigned counsel is not aware of any court ever granting such a request."
Also worth noting...
The plaintiff, Public Health and Medical Professionals for Transparency (PHMPT), is a group of doctors and scientists, including Harvey Risch, a professor of epidemiology at the Yale School of Public Health.
The way I read it, the PHMPT is asking for something that may not be possible given what the FDA has to go through to provide the documents. The filing lists the reasons why the FDA says it cannot meet the requested timeline. Go read those reasons on pages 4-8 of the filing.
Not sure how this turned into the claims that the FDA must be hiding something? I'm sure everyone complaining read through the filing first right? Or did they just read the twitter outrage?
Quote:
Not sure how this turned into the claims that the FDA must be hiding something? I'm sure everyone complaining read through the filing first right? Or did they just read the twitter outrage?
Do you even Epoch Times, Bro?
I agree with you. It's still a misleading headline.
My pronouns are AFUERA/AHORA!
TexasAggie_02 said:
it's not misleading. If the FDA was able to approve it in less than a year, then it shouldn't take 55 years to produce documentation on that approval.
I'm sure you read through the filing to try and understand why this may not be the case. But just in case you missed it during your review of the filing, here is what the FDA had to say regarding that claim:
"Third, the Court should flatly reject Plaintiff's specious argument that because the scientists reviewing Pfizer's Biologics License Application could do so on an expedited timeframe, the government information specialists should be able to do so in the same period of time. As should be apparent, the review conducted by FDA scientists when considering to approve a product is entirely different from the review conducted by FDA government information specialists when considering whether FDA must keep certain information confidential. Moreover, FDA's FOIA office does not have nearly the same level of personnel or resources dedicated to process FOIA requests as FDA has marshaled to review license applications for live-saving products in the middle of a pandemic."
In the spirit of transparency, why couldn't it just be released without forcing it through the FOIA process?
Ernest Tucker said:
In the spirit of transparency, why couldn't it just be released without forcing it through the FOIA process?
"Plaintiff has requested records that comprise information submitted by the vaccine sponsor (Pfizer-BioNTech). From FDA's experience with other FOIA requests, such records can be expected to contain both confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials. FDA is required to protect certain information under the law and this type of information is exempt from production under the FOIA. See 5 U.S.C. 552(b)(4), (b)(6); F.B.I. v. Abramson, 456 U.S. 615, 621 (1982) ("Congress realized that legitimate governmental and private interests could be harmed by release of certain types of information and provided nine specific exemptions under which disclosure could be refused.").To ensure protection of this information, and other information subject to withholding under the FOIA exemptions, FDA must carefully review and, if necessary, redact exempt information on a line-by-line basis. See Daily Caller, 152 F. Supp. 3d at 14 (stating that the government has a "responsibility" when processing FOIA requests to "safeguard[] potentially sensitive information"). This type of review for more than 329,000 pages will necessarily require time if the agency is going to be able to perform the careful analysis necessary to protect sensitive information."
If the documents were just released without going through the process, the FDA would be in a lawsuit with Pfizer and/or individuals that were in the clinical trials.
Still doesn't make sense, if they truly wanted the broader public to be able to review this info on something that will literally impact millions.
Why couldn't they allocate the personnel on a special basis to review the documents for release on an expedited timeframe?
They are able to do it for emergency release and instant broad immunity of liability, but now they can't afford the staff to review the areas that contain potentially proprietary information to redact? For 55 years? Not all of those 330,000 pages need to be reviewed with a microscope line by line either.
Seems unreasonable
Why couldn't they allocate the personnel on a special basis to review the documents for release on an expedited timeframe?
They are able to do it for emergency release and instant broad immunity of liability, but now they can't afford the staff to review the areas that contain potentially proprietary information to redact? For 55 years? Not all of those 330,000 pages need to be reviewed with a microscope line by line either.
Seems unreasonable
I'd encourage everyone to read the filing.
"Second, the FDA does not have the personnel or resources in its FOIA office to process
Plaintiff's FOIA request at a rate of more than 80,000 pages per month. Plaintiff's FOIA request
is being processed by the Access Litigation and Freedom of Information Branch (the "Branch") in
FDA's Center for Biologics Evaluation and Research ("CBER"). The Branch has a total of ten
employees, including the director and two trainees. It is currently responsible for processing a
total of approximately 400 currently pending FOIA requests, including Plaintiff's. CBER is
currently involved in 6 active FOIA litigation matters. By processing and making interim
responses based on 500-page increments, FDA will be able to provide more pages to more
requesters, thus avoiding a system where a few large requests monopolize finite processing
resources and where fewer requesters' requests are being fulfilled. Simply put, processing
resources are finite. Increasing the volume to more than 80,000 pages per month (if such rate is
even possible and it likely is not), as Plaintiff requests, would result in Plaintiff monopolizing
essentially all of FDA's resources and leaving little resources to process other FOIA requests.
Indeed, the D.C. Circuit has recognized that another agency's policy of processing 500 pages per
request per month "serves to promote efficient responses to a larger number of requesters." Nat'l
Sec. Counselors v. Dep't of Justice, 848 F.3d 467, 47172 (D.C. Cir. 2017); see also Elec. Privacy
Info. Ctr. v. Dep't of Justice, 15 F. Supp. 3d 32, 47 (D.D.C. 2014) (denying motion for preliminary
injunction requesting immediate production of documents pursuant to FOIA request and noting
that allowing the plaintiff "to jump to the head of the line would upset the agency's processes and
be detrimental to the other expedited requesters"); Daily Caller, 152 F. Supp. 3d at 14 (stating that
"the plaintiff's effort to jump to the head of the FOIA processing line would work a significant
burden on both the agency and numerous interested parties")"
...
"Fifth, although Plaintiff takes issue with the amount of time it will take to process 329,000
pages at a rate of 500 pages per month, such a result is due to its own broad FOIA request. Courts
do not waiver from the standard 500 page per month processing rate even when a FOIA request
would take years to process. See, e.g., Colbert v. F.B.I., No. 16-CV-1790 (DLF), 2018 WL
6299966, at *3 (D.D.C. Sept. 3, 2018) (permitting a processing rate of 500 pages per month for
71,000 responsive records). FDA has invited Plaintiff to narrow its request by specifying records
it no longer wants FDA to process and release, and Plaintiff has declined to do so. If Plaintiff
decides to request fewer records, then FDA will be able to complete its processing at an earlier
date."
Personally I find the part I bolded interesting. The PHMPT could make this go faster if they narrow what documents are being requested.
"Second, the FDA does not have the personnel or resources in its FOIA office to process
Plaintiff's FOIA request at a rate of more than 80,000 pages per month. Plaintiff's FOIA request
is being processed by the Access Litigation and Freedom of Information Branch (the "Branch") in
FDA's Center for Biologics Evaluation and Research ("CBER"). The Branch has a total of ten
employees, including the director and two trainees. It is currently responsible for processing a
total of approximately 400 currently pending FOIA requests, including Plaintiff's. CBER is
currently involved in 6 active FOIA litigation matters. By processing and making interim
responses based on 500-page increments, FDA will be able to provide more pages to more
requesters, thus avoiding a system where a few large requests monopolize finite processing
resources and where fewer requesters' requests are being fulfilled. Simply put, processing
resources are finite. Increasing the volume to more than 80,000 pages per month (if such rate is
even possible and it likely is not), as Plaintiff requests, would result in Plaintiff monopolizing
essentially all of FDA's resources and leaving little resources to process other FOIA requests.
Indeed, the D.C. Circuit has recognized that another agency's policy of processing 500 pages per
request per month "serves to promote efficient responses to a larger number of requesters." Nat'l
Sec. Counselors v. Dep't of Justice, 848 F.3d 467, 47172 (D.C. Cir. 2017); see also Elec. Privacy
Info. Ctr. v. Dep't of Justice, 15 F. Supp. 3d 32, 47 (D.D.C. 2014) (denying motion for preliminary
injunction requesting immediate production of documents pursuant to FOIA request and noting
that allowing the plaintiff "to jump to the head of the line would upset the agency's processes and
be detrimental to the other expedited requesters"); Daily Caller, 152 F. Supp. 3d at 14 (stating that
"the plaintiff's effort to jump to the head of the FOIA processing line would work a significant
burden on both the agency and numerous interested parties")"
...
"Fifth, although Plaintiff takes issue with the amount of time it will take to process 329,000
pages at a rate of 500 pages per month, such a result is due to its own broad FOIA request. Courts
do not waiver from the standard 500 page per month processing rate even when a FOIA request
would take years to process. See, e.g., Colbert v. F.B.I., No. 16-CV-1790 (DLF), 2018 WL
6299966, at *3 (D.D.C. Sept. 3, 2018) (permitting a processing rate of 500 pages per month for
71,000 responsive records). FDA has invited Plaintiff to narrow its request by specifying records
it no longer wants FDA to process and release, and Plaintiff has declined to do so. If Plaintiff
decides to request fewer records, then FDA will be able to complete its processing at an earlier
date."
Personally I find the part I bolded interesting. The PHMPT could make this go faster if they narrow what documents are being requested.
Mid November and we still have no FDA approved "vaccine" (dubiously used). Everything being injected is still a EUA.
Quote:
Mid November and we still have no FDA approved "vaccine" (dubiously used). Everything being injected is still a EUA.
https://www.npr.org/sections/coronavirus-live-updates/2021/08/23/1030251410/pfizer-covid-vaccine-fda-approval
Quote:
Pfizer-BioNTech's COVID Vaccine Gets Full Approval From The FDA
Updated August 23, 20212:58 PM ET
The Food and Drug Administration has formally approved Pfizer's COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization granted by the agency last December.
The vaccine, developed by Pfizer and its partner BioNTech, is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine on par with other marketed vaccines.
I've only read what has been posted on this thread, and I really don't know what information is being requested, but my first thought is that the data probably has a lot of personal health information in it. There is probably an agreement between Pfizer and the FDA with regards to sharing the PHI, which is why it can be easily shared during the vaccine approval process. If you release it publicly without masking the data first, you're going to be giving out people's SS #s, DOB, etc.Ernest Tucker said:
In the spirit of transparency, why couldn't it just be released without forcing it through the FOIA process?
I don't know for certain that's the deal, but as someone who works for a medical company, I can tell you that sharing data in house is fairly simple. Sharing it with a third party, can be a pain in the ass.
50 Billion dollars and they can only squeeze out 500 pages a month?
“You can resolve to live your life with integrity. Let your credo be this: Let the lie come into the world, let it even triumph. But not through me.”
- Alexander Solzhenitsyn
- Alexander Solzhenitsyn
That's 25 pages per day assuming 20 work days per month. It's a pitiful excuse. One person should be able to do that before the morning coffee/smoke break.JFABNRGR said:
50 Billion dollars and they can only squeeze out 500 pages a month?
55,000 pages per month.
I am pleased to report a federal judge rejected the FDA's request to produce the Pfizer Covid vaccine data at 500 pages per month and instead ordered a rate of 55,000 pages per month! Everyone should read the Judge's excellent 3-page decision available at https://t.co/ziqCs9fA9J
— Aaron Siri (@AaronSiriSG) January 6, 2022
That decision is crap. It gives a bunch of reasons why FOIA are good (fine) and says nothing about the unreasonableness or reasonableness of the request. In other words, it completely ignored the crux of the matter to make a grandstanding speech everyone agrees with. There's nothing in the order that explains how they arrived at the pages per month, why it's reasonable, how it's supposed to happen, or how other FOIA requests may be impacted.
I'm all for transparency. But this looks to me like an unreasonable and burdensome request - a shotgun approach which certainly will produce a bunch of useless documents. It's kind of like a reverse document dump on a legal team.
I'm all for transparency. But this looks to me like an unreasonable and burdensome request - a shotgun approach which certainly will produce a bunch of useless documents. It's kind of like a reverse document dump on a legal team.
The judge who entered that order, Mark Pittman, is an Ag. We were previously coworkers. It might be a reasonable ruling, but I agree that it's hard to determine based only on his order.
Why wouldn't this just be turned over to the public? There's no reason to withhold this information, absolutely no reason at all… we the citizens want it and it should be given without any kickback at all….
But we all know why.. there is stuff in there they don't want us to know.. no other reason
But we all know why.. there is stuff in there they don't want us to know.. no other reason
fullback44 said:
Why wouldn't this just be turned over to the public? There's no reason to withhold this information, absolutely no reason at all… we the citizens want it and it should be given without any kickback at all….
But we all know why.. there is stuff in there they don't want us to know.. no other reason
Considering the American taxpayer is the single largest investor in the development of the technology and one of the largest customers I see no realistic response from the companies. Other than " Yes Sir! Single side or front and back copies?"
Those documents are very likely loaded with all kinds of information that is exempt from FOIA for good policy reasons. Probably most significantly, personal information regarding the patients who participated in the trials. They will have to be reviewed page by page and line by line to redact everything the government can't release by law. Large document productions are not quick and easy tasks even for the largest law firms who can hire armies of contract lawyers working around the clock to conduct the heavy lifting. For a federal agency's FOIA office, this will be overwhelming.
Good thing the companies earned about $34 billion last year. I'm sure they can hire some help.
This is a FOIA request. The companies aren't involved.
shovel pass said:
This is a FOIA request. The companies aren't involved.
Would bet money that they're about to be. It's 3:45 pm on a Friday when you get the email from your RegAffairs lead…so FDA just sent us an information request and needs an answer by COB on Tuesday or they'll put our program on hold.
Those *******s at FDA ****ing deserve this.
That isn't how FOIA works at all. There will be no "information request" from the FDA to Pfizer or anyone else. This is a request for records in the possession of the FDA.