From [AARONSIRI,ESQ] 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 just 108 days.  It took the FDA’s parent department even less time to grant Pfizer complete immunity to liability for injuries from this product, and it took a stroke of the President’s pen to mandate this product for federal employees, the private sector and military personnel. 

The federal government mandating that millions of people be injected with a liability-free vaccine requires complete government transparency – not the government’s suppression of information.  PHMPT is comprised of independent scientists working at some of our nation’s premier institutions, and all they are seeking is the data the FDA has already reviewed concerning the Pfizer vaccine in order to provide the necessary peer review.  The FDA knows that they, and other independent scientists, cannot properly analyze that data until it is all released.  Yet, the FDA wants to wait until most of those scientists are long since dead to fully release the data.  News outlets, politicians, and scientists have called the FDA’s position “outrageous.”  They are correct.

The entire purpose of FOIA is government transparency.  In multiple recent cases, in upholding the FOIA’s requirement to “make the records promptly available,” courts have required agencies, including the FDA, to produce 10,000 or more pages per month, and those cases did not involve a request nearly this important – i.e., the data underlying licensure of a liability-free product that the federal government requires nearly all Americans to receive.  As the present pandemic rages on, independent review of these documents by outside scientists is urgently needed to assist with addressing the shortcomings and issues with the response to the pandemic to date.  [MORE]