Decision rejects FDA request to release the data over 75 years.
QUICK FACTS:
- A federal judge on Thursday ordered the U.S. Food and Drug Administration (FDA) to produce the documents it relied on to license the Pfizer-BioNTech Covid-19 vaccine, The Epoch Times reports.
- The FDA is to release the documents at a rate of 55,000 pages per month, meaning the agency has just over eight months to produce all of Pfizer’s pre-licensure safety data.
- The ordered frequency of document release is significantly faster than the 500 pages-per-month rate the FDA proposed in December 2021, the Times notes, a rate that would have effectively given the agency roughly 75 years to fully produce the data.
WHAT THE JUDGE ORDERED:
- U.S. District Judge Mark Pittman ordered the FDA to produce more than 12,000 pages on or before Jan 31, according to the Times.
- Judge Pittman also 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.”
- “Here, the court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA,” the judge admitted. “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.”
- “Accordingly, the court concludes that this FOIA request is of paramount public importance,” Pittman wrote.
BACKGROUND:
- The Public Health and Medical Professionals for Transparency (PHMPT) brought the case to the court, saying the data should be made public quickly because the FDA took just 108 days to review the data before granting Pfizer’s Covid-19 vaccine full approval, the Times reports.
- “All the documents sought in the FOIA request are urgently needed to allow independent scientists to review the FDA’s work and to provide assurance to the public that the liability-free vaccine [Americans] are being mandated to receive has truly passed the most rigorous review possible,” the group said in its December filing, adding, “[T]he need for this information will be lost if all the documents are not promptly produced because people and governments are making decisions regarding the Pfizer vaccine now, not in 75 years.”
