Somewhere on the other side of the growing heap of government and pharma lawyers is transparency.
As explained in prior posts, 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.
Meanwhile…
As the FDA tries to obtain months of delay, guess who just showed upon in the lawsuit? Yep, Pfizer. And it is represented by a global chair and team from a law firm with thousands of lawyers. Pfizer’s legal bill will likely be multiple times what it would cost the FDA to simply hire a private document review company to review, redact, and produce the documents at issue. Within weeks, if not days.
Pfizer is coming in as a third party. But Pfizer assures the Court it is here to help expedite production of the documents. Sure it is! Where was Pfizer before the Court ordered the 55,000 pages per month? Right, doing what it normally does: letting the government work on its behalf – like the way the government mandates, promotes, and defends Pfizer’s product.
But the government did not please Pfizer this time and so here it comes, likely looking for a second bite at the apple. Of course the FDA consented to Pfizer appearing. You can read the response my firm filed to Pfizer’s motion , as well as all of the other relevant recent filings in the link provided below.
Let me end by noting that 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 introduction from the brief opposing the FDA’s request is below and you can find copies of all the relevant court filings (FDA Motion to Modify Scheduling Order, January 18, 2022 / Plaintiff Opposition to Motion to Modify, January 24, 2022 / Pfizer Motion to Intervene, January 21, 2022 / FDA Response to Pfizer Motion, January 25, 2022 / Plaintiff Response to Pfizer Motion, January 25, 2022) here:
INTRODUCTION TO OPPOSITION TO FDA’S MOTION
It is understandable that the FDA does not want independent scientists to review the documents it relied upon to license Pfizer’s vaccine given that it is not as effective as the FDA originally claimed, does not prevent transmission, does not prevent against certain emerging variants, can cause serious heart inflammation in younger individuals, and has numerous other undisputed safety issues.[1] However, the FDA’s potential embarrassment over its decision to license this product must take a back seat to the transparency demanded by FOIA and the urgent need and interests of the American people to review that licensure data. The Court already recognized this unprecedented urgent need in its January 6th order directing the FDA to produce 55,000 pages per month.
The FDA now insists it must delay its first 55,000-page production until May 1, 2022 – four months after the Court entered its order. However, the FDA’s own papers seeking this delay make plain it can produce at a rate of 55,000 pages per month in February and March. 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. FDA’s reality defying claim and contemptuous approach to its production obligations should not be countenanced. (Infra § I.)
CONTINUE READING
https://aaronsiri.substack.com/p/fda-asks-the-court-to-delay-first