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A group of scientists and medical researchers sued the FDA under FOIA to force release of hundreds of thousands of documents related to licensing of the Pfizer-BioNTech Covid-19 vaccine. Plaintiff’s attorney Aaron Siri, who is representing the group, explains the fight that led a federal court to order expedited release of documents the agency claimed it would take decades to process.
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U.S. District Judge Mark T. Pittman, Northern District of Texas, expressed dismay at the FDA’s proposed rate of production. He found the duration requested by the FDA unreasonable, comparing it to the actions of totalitarian nations. As such, the judge on Jan. 6 ordered the FDA to produce at least 55,000 pages per month.
In his ruling, the judge recognized that the release of this data is of paramount public importance and should be one of the FDA’s highest priorities. He quoted James Madison as saying a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy” and John F. Kennedy as explaining that a “nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”
America has some of the greatest institutions of learning the world has ever known. We need the scientific community, both inside and outside the government, to address the serious ongoing issues with the vaccine program, including waning immunity, variants evading vaccines, and that vaccinated individuals can still transmit the virus.
The FDA’s attempt to close the door and lock out independent scientists from the data necessary to address these issues was irresponsible.
Transparent, Independent Review Is Needed
The failure of the government’s closed-door approach is exemplified by the fact that the FDA did not send a representative to the court hearing because, as the government attorney explained, the FDA’s Covid-19 protocols would not permit it.
Meaning, despite a reported vaccination rate of over 96% across federal health agencies back in November 2021, and the FDA’s claim that the vaccines are “effective,” Covid-19 is still disrupting everyday life. This brings into stark focus the need to open the door and involve independent scientists.
As Pittman recognized, America needs transparency and independent scientists to review this data—not in 75 years, but now.
This article does not necessarily reflect the opinion of The Bureau of National Affairs, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.
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Author Information
Aaron Siri is the managing partner of Siri & Glimstad LLP, and has extensive experience in a wide range of complex civil litigation matters, with a focus on civil rights involving mandated medical procedures, class actions, and high-stakes disputes. Twitter @aaronsirisg.
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