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They approved the vaccine. The general expectation is that they released the approval after reading relevant information. They have 329,000 pages of information, so it can only go 2 ways : They either had enough people to already go through those documents, analyse them and conclude the vaccine was safe in about a month. In which case, they could reallocate those people for a month to redact said documents. The alternative being that they reviewed a small portion of said documents, which would render their argument completely moot, since they would only need to release the documents they actually used during their decision

I would expect the redaction to be way less involved than their review and analysis.

Worst case, they could hire the same number of people for a month to do nothing but redact those documents. In the unlikely case their whole agency was busy reading and analyzing all 329k documents, and redactors would be paid on average the same amount as the average FDA employee, it would cost the FDA 10% of its annual 2020 HR budget, which would be $600M, or $2,000 per page, which sounds absolutely ludicrous.

on the other hand, it seems general population vaccination should be at the top of their priorities. Releasing those documents should only help them fulfilling that goal. So they should invest in said release.

No matter how you're looking at it, "shenanigans" seems to be the most appropriate term here.

"The alternative being that they reviewed a small portion of said documents, which would render their argument completely moot, since they would only need to release the documents they actually used during their decision"

This is incorrect - this is not actually what they requested. Look at the complaint (https://fingfx.thomsonreuters.com/gfx/legaldocs/klvykdlryvg/...), paragraph 5

CFR (code of federal regulations) says: "“After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown: (1) All safety and effectiveness data and information. (2) A protocol for a test or study . . .” 21 C.F.R. § 601.51(e)."

They requested all data that 21 CFR 601.51 authorizes, except for the adverse reaction reports available in the VARS database.

So whether the FDA reviewed or relied on all 329,000 pages, they are requesting all 329,000 pages.

Worse, of course, is that they deliberately ...'d the part that makes it take so long (this will, btw, piss off the judge and clerk who read the brief, since they will go and read that and see immediately that it happened)

Go look at 21 CFR 601.51(e) and subsequent parts, and you can see the FDA is required to do exactly what they said: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...

In practice, this is just the posturing phase - 90% of what the plaintiffs requested is probably pointless.

The CFR says " (g) For purposes of this regulation, safety and effectiveness data include all studies and tests of a biological product on animals and humans and all studies and tests on the drug for identity, stability, purity, potency, and bioavailability."

So like, this is probably tens of thousands of pages of blood pressure and heart rate readings for 10,000 anonymous people kind of thing. Along with tens of thousands of pages of blood test results, etc.

And then tens of thousands of pages of purity testing of random vaccine lots ;)

Usually, the judge will tell both sides to try to figure it out, they will get together and the plaintiffs decide "yeah, maybe we only really need 10k pages" and the defendants decide "yeah, we can do 10k pages in 3-4 months" and the case settles.

It would be super unlikely for the judge to order the FDA to produce 329,000 redacted pages of documents in very short order.

> They either had enough people to already go through those documents, analyse them and conclude the vaccine was safe in about a month. In which case, they could reallocate those people for a month to redact said documents.

These are different jobs with different qualifications. The people who decide whether your vaccines are safe are not experts in processing FOIA requests, nor is that a reasonable use of their time when the FDA has actual regulatory work to do. And if it doesn’t violate any federal hiring regulations, it’s certainly a good way to lose important employees.

> How long would it take a team of 10 people to even read 329,000 pages of documents in addition to their current workload, let alone review those documents, which likely would frequently require back and forth consultations with others to do properly (e.g. the legal department or Pfizer's people)? How likely is is that they'll get money appropriated to beef up staffing levels of their FOIA team to get this done much more quickly?

Why on earth is there even a potentiality of anything __compromising__ in there to even have to fucking review it?

Everything FDA should be presumed public. Like. Everything.

> Everything FDA should be presumed public.

Naively, it seems to me that a regulator requires trade secrets to be disclosed to it in order to do its job well.

I don’t think peoples PII/PHI should be presumed public. FOIAs exemptions are not without reason.

Then no one will sign up for trials because that would mean all their personal information and medical history will become public which could result in them not getting hired.

Then filter out PHI/PII on ingress, not on egress. This isn't a problem that can't be solved.

Don't accept documents that don't have these properly separated out. Don't accept documents that put non PII data in the "PII Pile".

If a company keeps fucking it up, fine them for all the extra work they've made FDA do and eventually drop trust in them and don't accept anything from them. Essentially kill the company.

FDA's data should not be private/for fee. Nor should any of the articles that the FDA uses to make its decisions.

Per the OP

>To meet the plaintiffs’ proposed FOIA deadline, the FDA would have to process a daunting 80,000 pages a month. But the plaintiffs note that the FDA has 18,000 employees and a budget of $6 billion and “has itself said that there is nothing more important than the licensure of this vaccine and being transparent about this vaccine.”

Assuming that all 18,000 employees can actually do the work. Im sure some FDA employees are spread through out various states and have various different responsibilities like focusing on the 'F' in FDA. And those people might not be qualified to work on the processing of papers on vaccines and drugs. That also assumes that they don't overload pfizer and other drug makers with questions that they can't answer in a reasonable time to meet the proposed deadline.

> But the plaintiffs note that the FDA has 18,000 employees and a budget of $6 billion

So what? Are they supposed to do stuff like assign the software development team to do document review for the next couple years? Because I'm pretty sure almost all of those 18,000 employees have very different jobs than FOIA document review (and may not appreciate reassignment), and that budget is already allocated to other stuff that's probably higher priority.

Also, the bottleneck may not only be staffing. What if they staff this with 1,000 people, and those guys are all waiting on one dude at Pfizer?

> and “has itself said that there is nothing more important than the licensure of this vaccine and being transparent about this vaccine.”

A FIOA request has nothing to do with licensure, and transparency doesn't necessarily mean doing whatever someone demands (to give an exaggerated example: if you say it's important to be transparent, and someone asks for nudes "for transparency," they haven't proven you wrong if you don't provide them), or doing that thing on their schedule.

Does they mean they never read it before approving it?

Why would it?

I think that is a given

Should they have delayed the emergency authorization of the vaccines until these 330,000 pages had all been reviewed and redacted? It would have cost hundreds of thousands of lives, but I can't see any benefit from that course of action.

Should they delay the FOIA release until these 330,000 pages had all been reviewed and redacted? I don’t think the answer to either of these questions are “no”, though ofc the standard could vary.

emergency authorization != approval.

These shenanigans show that the approval can't have been based on all the information. They should have delayed the approval, at least until Phase III trial officially ended.

How many lives would that have cost, though, and for what benefit? The size of the sample that had already received the vaccine without issue made it basically impossible [0] for there to have been an unexpected danger. And without approval, the govt couldn't mandate federal employees take the vaccine, and that mandate has saved tens of thousands of lives.

[0] https://en.m.wikipedia.org/wiki/Power_of_a_test

I'm assuming whoever made the decision read the summary. The majority of those "pages" are probably just raw data. Most of it is probably each experimental patient's temperature and blood pressure, each time they got checked, one page at a time.

I'd bet that no one person has read all 329,000 pages, but I would bet that somebody looked at almost any given page.

I'm hedging a bit on "any" because a New Drug Application is supposed to contain "the whole story of the drug." As a result, it includes the original and translated copies of any non-English publications related to the drug. It includes case reports for every participant who died during the trial, including in the placebo group. It includes information on related patents and licensing arrangements.