A prior post explained that the FDA has asked a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine. Literally, a 55-year delay. My firm, on behalf of PHMPT, asked that this information be disclosed in 108 days – the same amount of time it took for the FDA to review and license Pfizer’s vaccine.
The Court ordered the parties to submit briefs in support of their respective positions by December 6, 2021. The FDA’s brief, incredibly, doubles down. It now effectively asks to have until at least 2096 to produce the Pfizer documents. Not a typo. A total of at least 75 years.
Other than producing an initial ~12,000 pages in around two months, the FDA thereafter only wants to commit to producing 500 pages per month. The FDA also disclosed that it actually has approximately at least 451,000 pages to produce.*
Each side gets to file response briefs on December 13, 2021, and then there is oral argument on December 14, 2021 before the Judge. If you want to read the response to the FDA’s position, a copy of the introduction in the brief my firm filed is below. And below that, a downloadable copy of each side’s full briefing is available.
Enjoy. And if you find what you are reading difficult to believe – that is because it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure. The lesson yet again is that civil and individual rights should never be contingent upon a medical procedure.
EXCERPT FROM BRIEF DEMANDING TIMELY PRODUCTION
INTRODUCTION
A minimum of 20,010 days (54 years and 10 months). That is how long the FDA proposes to take, at a rate of 500 pages per month, to produce only a portion of the documents in its file for the COVID-19 Pfizer vaccine that PHMPT requested pursuant to the Freedom of Information Act (the “FOIA Request”) and 21 C.F.R. § 601.51(e). But when it came to reviewing those same documents to license this product so that Pfizer could freely sell it to the public, the FDA took…
Read full story [icon name=”arrow-right” prefix=”fas”] FDA Doubles Down: Asks Federal Judge to Grant it Until at Least the Year 2096 to Fully Release Pfizer’s COVID-19 Vaccine Data