FDA to reveal Pfizer Vaccine Approval Data

[George K]

In 50 years...

The Food and Drug Administration (FDA) requested Monday for the courts to give them until 2076 to review and fully release the documents pertaining to the approval of the Pfizer BioNTech COVID-19 vaccine.

The FDA denied Sept. 9 a request for an expedited release of the vaccine’s approval records from a group of doctors and scientists, the Public Health Medical Professionals for Transparency (PHMPT). The PHMPT has since filed a lawsuit against the FDA for failure to complete their Freedom of Information Act (FOIA) request.

The agency had determined that there were a total of 329,000 pages that needed to be reviewed in order to fulfill the plaintiff’s FOIA request, and proposed that they would be able to “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” The FDA said they would provide the plaintiff with prioritized documents and release the non-exempt portions of the records on a “rolling basis.” This rate of review places the FDA’s release of the documents at nearly 55 years.

“This rate is consistent with processing schedules entered by courts across the country in FOIA cases,” said the FDA, explaining that the plaintiff’s request for documentation within a 4-month timeframe would force the FDA to have to work through 80,000 pages per month.

[LuFins Dad]

I can’t for the life of me understand why there is a lack of trust.

[Axtremus]

Do the data include all the identities of the doctors and support staff involved in administering the shots, collecting samples, and crunch the numbers? Do the data include the identities and detailed health statistics of all the individuals involved, including those who were given placebos? Are we talking physical paper documents, scanned pages of such documents, or records already digitized and normalized in electronic databases?

Depends on how the FOIA request was worded, it may indeed take “50 years” to properly vet “everything” for release. But anonymized aggregate statistics should already be available and should be released already.

[Jolly]

Just no.

I don't think this has ever been done before nor should it.

[Jolly]

@axtremus said in FDA to reveal Pfizer Vaccine Approval Data:

Do the data include all the identities of the doctors and support staff involved in administering the shots, collecting samples, and crunch the numbers? Do the data include the identities and detailed health statistics of all the individuals involved, including those who were given placebos? Are we talking physical paper documents, scanned pages of such documents, or records already digitized and normalized in electronic databases?

Depends on how the FOIA request was worded, it may indeed take “50 years” to properly vet “everything” for release. But anonymized aggregate statistics should already be available and should be released already.

Uh, no.

In clinical trials, you can trace everything down to the individual patient, at least in all I've been a part of. The big decisions are made on the big numbers, but the CRA's do have individual data in their files. The drug company can quickly drill down as far as they need to.

[LuFins Dad]

Either way, 500 days a month? The FDA could and should be able to vet 500 pages a day if not more. Hell, one would think that they would be generating a bland-just the facts report specifically for release for FOIA requests.

[Axtremus]

@lufins-dad said in FDA to reveal Pfizer Vaccine Approval Data:

… one would think that they would be generating a bland-just the facts report specifically for release for FOIA requests.

Depends on what’s requested. It’s not uncommon for FOIA requests to be worded very broadly. Cannot judge until we see the actual FOIA request.

[Axtremus]

@jolly said in FDA to reveal Pfizer Vaccine Approval Data:

Just no.

I don't think this has ever been done before nor should it.

You are saying you don’t want the FDA to release any trial data at all, is that right?

[Jolly]

Nope.

[Mik]

I don't see how trial data can possibly be of use to anyone, and if it went down to the individual level it could be harmful to participants. I could see them releasing an abstract of it as they do other medical studies.

But again, it depends what was requested in the FOIA request.

[jon-nyc]

Right wing media, echoed in George’s post, is reporting this as releasing it “in 50 years”. It’s really “over 50 years”, with the requester able to prioritize things. Maybe foia requests that result in 315,000 pages are a tad over broad.

Typical drug approval start to finish requires about 100,000 pp of documentation to be sent to the FDA. That’s a stat I heard just the other day from an old AZ guy. That includes such minutiae as training documents for site coordinators. Doubtful FDA looks at even 1/10 of it.

[jon-nyc]

From Reuters:

But the FDA can’t simply turn the documents over wholesale. The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” wrote DOJ lawyers in a joint status report filed Monday.

The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests.

“By processing and making interim responses based on 500-page increments, FDA will be able to provide more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources and where fewer requesters’ requests are being fulfilled,” DOJ lawyers wrote, pointing to other court decisions where the 500-page-per-month schedule was upheld.

[Mik]

Makes sense.