FDA is required by a federal judge to release COVID-19 trial data more quickly.
Prepare to delve into some delicious data! All trial-related documents for Moderna’s adult trial and Pfizer’s juvenile trial must be made public by the middle of 2025, according to Judge Mark Pittman’s order. In the past, the FDA has delayed disclosure of this information and planned to do so for 23.5 years. But now we’ll have around 180,000 pages a month to read, thanks to Judge Pittman. It’s time to get your analytical hat on!
To report 4.8 million pages over 1,000 to 16,000 pages each month for a staggering 24 years was judged “impractical” by the FDA.
The decision was reached in a lawsuit filed by plaintiffs against the FDA after their kid suffered harm as a result of receiving the COVID-19 immunization. “Democracy dies behind closed doors,” In his decision, Pittman wrote. The court acknowledged that he is aware that the FDA only has a limited amount of funding available to answer Freedom of Information Act (FOIA) requests, but he reasoned : “the number of resources an agency dedicates to such requests does not dictate the bounds of an individual’s FOIA rights.”
“Instead, the Court must ensure that the fullest possible disclosure of the information sought is timely provided—as ‘stale information is of little value,’” Pittman wrote.
In a key decision, the court mandated that the FDA expedite the disclosure of information on Pfizer’s COVID-19 vaccine for those 16 and older. They must divulge 55,000 pages of data each month as a result of this judgment, which expands upon an earlier order. The FDA had proposed a stunning 75-year delay in disclosing the information prior to the decision. Those looking for openness and quick access to critical health information may rejoice at this news.
The decision was “another blow for transparency and accountability,” according to plaintiffs’ attorney Aaron Siri. referring to the previous sequence. “That production should be completed in a few more months,” In a statement, Siri stated.
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Pittman contends that delaying the sharing of trial data damages public health authorities’ credibility and pushes for a quicker turnaround in the January 2022 order.
