From:
https://tinyurl.com/4ap6de6z
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FDA Says It Now Needs 75 Years to Fully Release Pfizer COVID-19 Vaccine Data
By Zachary Stieber
December 8, 2021
The Food and Drug Administration is asking a judge to give it 75 years to
produce data concerning the Pfizer and BioNTech vaccine, up 20 years from
a previous request.
The FDA told the court it can work faster than its previously proposed
500-pages-per-month rate, but it also said there are more than 59,000 more
pages than mentioned in an earlier filing.
That discovery, and a desire to make sure it can work on other Freedom of
Information Act requests at the same time, prompted the fresh request to
the judge to allow production of roughly 12,000 pages by Jan. 31, 2022,
and 500 pages per month thereafter.
That timeline would take it until at least 2096, Aaron Siri, a lawyer
working on the case, wrote in a blog post.
"If you find what you are reading difficult to believe-that is because it
is dystopian for the government to give Pfizer billions, mandate Americans
to take its product, prohibit Americans from suing for harms, but yet
refuse to let Americans see the data underlying its licensure," Siri said.
The case was brought on behalf of the Public Health and Medical
Professionals for Transparency, which stated that the FDA wasn't complying
with its request for data in a timely manner.
The group includes Dr. Carole Browner, a research professor at
the University of California-Los Angeles's David Geffen School of
Medicine; Peter Doshi, an associate professor at the University of
Maryland School of Pharmacy, and Dr. Harvey Risch, a professor of
epidemiology at the Yale School of Public Health.
The group says the data should be made public quickly because the FDA
spent just 108 days reviewing it before granting emergency use
authorization to the Pfizer-BioNTech vaccine.
The matter is more urgent because millions of Americans are being mandated
to take the shot or face repercussions, such as a loss of access to
businesses and employment termination.
The Pfizer shot is the only one that has been approved by drug regulators.
Approvals mean products have met a higher threshold of safety and
effectiveness than those given emergency clearance.
"The entire purpose of FOIA is government transparency. In multiple recent
cases, in upholding the FOIA's requirement to `make the records promptly
available,' courts have required agencies, including the FDA, to produce
10,000 or more pages per month, and those cases did not involve a request
nearly this important-i.e., the data underlying licensure of a
liability-free product that the federal government requires nearly all
Americans to receive," Siri said.
"As the present pandemic rages on, independent review of these documents
by outside scientists is urgently needed to assist with addressing the
shortcomings and issues with the response to the pandemic to date."
The FDA said its Center for Biologics Evaluation and Research maintains
the records sought by the plaintiff but only has 10 staff members, and two
of them are new, leaving them slower in processing pages than the other
workers.
Each line of each page must be reviewed to ensure proper redactions are
applied, the filing states.
Additionally, a faster rate than that requested would divert "significant
resources away from the processing of other FOIA requests that are also in
litigation," and requests that came in before the request in question, the
agency stated. "In sum, FDA's proposed processing schedule is fair to
plaintiff."
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-- Sean
... A gun in the hand is better than a cop on the phone.
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