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Message   Sean Dennis    All   75 yeaars for FOIA?   December 9, 2021
 1:33 PM *  

From: https://tinyurl.com/4ap6de6z

=== 
  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."
===

-- Sean

... A gun in the hand is better than a cop on the phone.
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