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Tipsheet

FDA Now Wants How Long to Release Data Supporting Licensing of Pfizer Vaccine?!

AP Photo/Andrew Harnik, File

The Food and Drug Administration has decided its 55-year request to release all of the data it relied upon to license the Pfizer Covid-19 vaccine was actually too quick of a turnaround time.

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Instead, the agency is now asking a federal judge to give it to at least 2096—or 75 years—to disclose the data.

Attorney Aaron Siri, whose firm filed a lawsuit against the FDA on behalf of the nonprofit Public Health and Medical Professionals for Transparency, explains the latest development.

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. (Aaron Siri)

Siri’s firm had asked that the data be disclosed in 108 days, which is how long it took for the FDA to review and license the Pfizer vaccine.

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“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,” Siri said in the brief.

“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.”

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