The Food and Drug Administration won’t have 75 years to release thousands of pages of documents it relied on to license its COVID-19 vaccine. Instead, the federal agency will have just over eight months to do so, per a federal judge’s ruling.
The timeline ordered Thursday by U.S. District Judge Mark Pittman radically shortens the timeline under which the FDA has to produce troves of documents. The order stems from a Freedom of Information Act document lawsuit by a coalition of doctors and scientists with the nonprofit Public Health and Medical Professionals for Transparency. The group seeks an estimated 450,000 pages of material about the vaccine-creation process during the COVID-19 pandemic, which came into full force in the United States in March 2020.
Rather than producing 500 pages a month, the FDA’s proposed timeline, Pittman ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of September rather than the year 2097, the deadline that the FDA wanted.
“Here, the court recognizes the ‘unduly burdensome’ challenges that this [Freedom of Information Act] request may present to the FDA,” the court ruling noted. “But, as expressed at the scheduling conference, there may not be a ‘more important issue at the Food and Drug Administration … than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not rush[ed] on behalf of the United States.”
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Pittman’s ruling requires the FDA to start producing documents at an expedited pace — more than 12,000 pages before Jan. 31. That timeline is also in line with the agency’s proposal. But deviating sharply from the FDA’s desired timeline, the judge ordered the agency to “produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.”
Public Health and Medical Professionals for Transparency said the data should be made public quickly because the FDA took just under four months to review the data before granting full approval for the Pfizer-BioNTech COVID-19 vaccine.
“Pfizer began its rolling submission on May 7, 2021, and the vaccine was licensed on August 23, 2021, a total of 108 days from initial submission to licensure,” it wrote in a December filing.
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Pittman cited a quote from the late Sen. John McCain, the Arizona Republican and 2008 GOP presidential nominee, that excessive secrecy from a government agency “feeds conspiracy theories and reduces the public’s confidence in the government.”
The FDA declined to issue a statement on the ruling and told the Washington Examiner the agency “does not comment on possible, pending, or ongoing litigation.”
