The United States District Court for the Northern District of Texas ruled against the Food and Drug Administration (FDA) in a high-profile case brought by the Public Health and Medical Professionals for Transparency (PHMPT).
The decision mandates the FDA to release the Emergency Use Authorization (EUA) file for the Pfizer-BioNTech COVID-19 vaccine no later than June 30, 2025.
The case stemmed from a Freedom of Information Act (FOIA) request by the PHMPT, which sought comprehensive data related to the Pfizer-BioNTech COVID-19 vaccine.
The FDA initially claimed it would need up to 75 years to process and release the requested documents. However, the Court, presided over by Judge Mark Pittman, rejected this argument, citing the importance of government accountability.
In late 2021, the U.S. Food and Drug Administration (FDA) faced significant public scrutiny after proposing a timeline that would extend the full release of documents related to the approval of Pfizer-BioNTech’s COVID-19 vaccine over several decades.
This proposal emerged following a Freedom of Information Act (FOIA) request by the Public Health and Medical Professionals for Transparency (PHMPT), a group of scientists and public health professionals seeking comprehensive data on the vaccine’s approval process.
The FDA initially suggested releasing 500 pages per month from a collection exceeding 300,000 pages, effectively delaying complete disclosure until around 2097. The agency cited limited staffing and the extensive volume of documents as reasons for this prolonged timeline.
In response to the backlash, U.S. District Judge Mark Pittman in Fort Worth, Texas, issued a ruling in January 2022 that significantly shortened the FDA’s proposed timeline.
Judge Pittman ordered the agency to release 55,000 pages per month, ensuring that all documents would be made public by the end of September 2022.
In his ruling, Judge Pittman ordered the FDA to produce the “emergency use authorization” file, underscoring that with the pandemic’s conclusion, there is no longer a valid reason to withhold the information.
The FDA has already produced over a million pages of documents in response to the lawsuit. However, the plaintiffs argue that the agency continues to withhold critical information.
Aaron Siri, representing the plaintiffs, stated, “The FDA clearly lacks confidence in the review that it conducted to license Pfizer’s COVID-19 vaccine because it is doing everything possible to prevent independent scientists from conducting an independent review.”
He continued, “The FDA was hiding from the court and the plaintiff one million pages of clinical trial documents from the COVID-19 vaccine clinical trials.”
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