Comment by molyss | Hacker News Reader

Comment by molyss | Hacker News Reader

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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.

> 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.

"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.

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