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Wait, What?
I know we are all really getting tired of the whole COVID thing, but little items like these keep popping up. From “Meaning in History,” today I learn that the Food and Drug Administration has asked a federal judge to grant it until the year 2076 to fully release Pfizer’s COVID-19 vaccine data. That’s right sports fans, the FDA wants 55 years to fully release the vaccine data. How did the FDA come up with this number, you ask? Well, according to the Freedom of Information Act request, Page 3, “FDA has assessed that there are more than 329,000 pages potentially responsive to Plaintiff’s FOIA request. (This page count is under-inclusive of the material responsive to the request, as it does not include certain types of records that cannot be meaningfully paginated, such as data captured in spreadsheets that contain thousands of rows of data.)” The problem is with the scheduling of the release of this information, as outlined on Page 4 of said FOIA request. What the FDA wants is “to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” Let’s stop here for a moment and do some simple math. The FDA has 329,000 pages of data to process. It wants to process these pages at a rate of 500 pages a month. So, 329,000 pages divided by 500 pages released per month equals 658 months to process all the documents. And 658 months divided by 12 months in one year equals 54.83 years.
The plaintiff in this FOIA (Public Health and Medical Professionals for Transparency) has requested this data to be provided to it within a four-month period, but the FDA says, “Plaintiff’s request (as set forth below) that FDA process and produce the non-exempt portions of more than 329,000 pages in four months would force FDA to process more than 80,000 pages per month. Undersigned counsel is not aware of any court ever granting such a request. The Court should decline to enter Plaintiff’s schedule for numerous reasons.” The “reasons” are covered in Pages 4-14 of the FOIA request. Bottom line: We know we are going to have to tell you plebs something, and we are going to do it in our own good time (insert middle finger here).
Published in General
It is my understanding that is how it works in Florida. Every document produced by the state is automatically public domain unless the state government gets a judge to agree to keep something secret before anybody files an FOIA request. The government has to proactively get a document declared secret, and doesn’t have the luxury of waiting for an FOIA request first so it can get a document made secret after-the-fact.
I’m highly sympathetic to the position that Florida’s FOI regime is how government documents should be treated, despite the side-effect that this regime is largely why Florida Man is a thing (since all arrest reports are automatically public domain documents, lazy reporters can just spend each day skimming through the reports to find the juiciest arrests, and Florida therefore gets a reputation for having lots of weird crimes).
It’s not the copying but rather the man-hours required to actually read all the documents to find out what’s in them so they can be redacted.
It’s way easier for computers to assemble data than for humans to read and understand it.
Ecclesiastes. IMHO.
What has to be redacted? If it is patient info, you can portably get rid of it by deleting a few spreadsheet columns. Or with a macro.
Or is the idea to be sure to retract anything that makes them look bad?
For most pharmaceuticals submitted to the FDA for approval I might agree, but the Covid vaccines are different. Their development was funded by the taxpayer, the supplies of the vaccine were purchased by the taxpayer, and the delivery of the vaccine is mandated by the government. Therefore, I say the vaccine is the property of the people and all details about it should be ruled public domain information.
But who is “you”? Melt into the blob where no one is responsible for anything…
I’m not worthy to answer that question. I’m not one of the anointed. Who are we to question the judgement of our betters in the FDA?
The CEO or Head of the Agency.
I don’t know how FOIA requests are done, but in a litigation discovery process, you don’t get to limit your disclosure to everything in the official folders labeled [issue]. Instead, you have to look through every document that was created or saved on everyone’s computers between date X and date Y.
Obviously that will include a lot of documents that are completely irrelevant such will have to be excluded. That’s normally done by running text string searches. In this case, if a document doesn’t include key words like Covid, Corona, vaccine, Pfizer, etc., it’s probably not relevant. Unfortunately that will catch things that aren’t relevant, like the Taco Tuesday flyer with its Mexican beer list. Eventually, you have to get eyeballs on documents, not just algorithms. (For instance, I know the main socialization space on the Apple campus is called Ten-Forward; I came across lots of festivity announcements when I was reviewing Apple documents.)
Once you’re down to the relevant documents, you have to make sure they don’t have confidential, privileged, or personally identifying information. In this case, there may have been classified military tech involved in the vaccine testing or development. There are probably at least a few emails or documents that include privileged legal advice from government or corporate lawyers. And what constitutes PII that must be redacted under HIIPA is far more detailed than most people appreciate.
To reiterate, I don’t think any of this work is so onerous it justifies the delays the FDA is requesting. I know from experience that Apple routinely has to deal with document requests in the millions of documents, and it doesn’t get half a century to comply on its own schedule. But it is work that has to be done.
There are worse reputations a state can have.
This is FDA time. It’s different than everybody else’s time. Consider one of the safest drugs known to medicine, e.g., Metformin (despite what you have heard or read on the internet). It took 50 years for the FDA to approve it for use in the US, after it was available everywhere else in the world. And then it required 3 of the top diabetologists in the nation to lobby the FDA for 10 years before it was approved. Consider that the drug was used as a plant extract of French lilac by Medieval apothecaries a thousand years before it was approved in the US and you get a real idea of the time reference frame of the FDA. Even Einstein would be amazed at FDA time. Neither Special nor General Relativity come close to explaining this phenomenon.
Which reinforces my belief that they can burn.
FDA seems to think all medicine emanates from them. Big Pharma has the resources to push back but even they hate to do that out of fear of retaliation.
Recall that under Bush and Clinton, FDA head Kessler went to war with makers of vitamins and herbal products in a joint push with the FTC. He made noises about seizing pro-vitamin pamphlets in waiting rooms in Dr’s offices. FDA even wrote publishers of medical textbooks to direct them remove claims for vitamin C. (They told Kessler to buzz off.) The medical profession as of the 1990s seemed to think that vitamins are good for you, even necessary for good health but the FDA took the position that they needed more proof before such claims should be made. Even for vitamin C!! (Perhaps the FDA noticed the discrepancies in Dr. Lind’s tome on scurvy (1747). The Royal Navy really should have done more controlled studies to resolve that, therefore the FDA could not condone health claims for Vitamin C.)
It is less about safety and more about turf and control. The FDA especially hates “right to try” legislation that allows terminal patients to choose to take not yet approved drugs with informed consent.
Sure – then hire a consulting agency to help review the documents.
Done.
Amy’s point exactly
The FDA likely knows that those documents contain a petard with which they will hoist themselves.
They’re shooting for the “What difference, at this point, does it make?” deadline. (Edit note: earlier I misquoted HRC)