Judge Gives FDA Just Over 8 Months to Produce Pfizer’s Safety Data
A federal judge on Thursday ordered the U.S. Food and Drug Administration to produce, at a rate of 55,000 pages per month, the documents it relied on to license the Pfizer-BioNTech COVID-19 vaccine.
The rate of 55,000 pages a month would mean the FDA has just over eight months to fully produce all of Pfizer’s pre-licensure safety data. That is much faster than the 500 pages-per-month rate the FDA proposed in December 2021. That rate would have effectively given the agency roughly 75 years to fully produce the data, Aaron Siri, a lawyer working on the case, previously observed.
U.S. District Judge Mark Pittman ordered the FDA to produce more than 12,000 pages on or before Jan. 31, which was what the FDA had proposed in part. Pittman then 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 … 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 in the order (pdf).
The FDA did not immediately respond to a request for comment on the latest ruling.
The case was brought by the Public Health and Medical Professionals for Transparency (PHMPT), which said the data should be made public quickly because the FDA took just 108 days to review the data before granting the Pfizer-BioNTech COVID-19 vaccine full approval.
“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,” the non-profit group noted in a December filing (pdf).
The group, which comprises public health professionals, medical professionals, scientists, and journalists, includes Dr. Harvey Risch, a professor of epidemiology at the Yale School of Public Health, Dr. Aaron Kheriaty, who was until recently a professor of psychiatry at UC Irvine’s School of Medicine, and Dr. Peter McCullough, a cardiologist, epidemiologist, and internist.
The Pfizer vaccine is currently the only COVID-19 vaccine that has been approved by U.S. drug regulators.
“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 filing in December, 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.”
In the initial complaint (pdf), the PHMPT said there is an “urgent” need for the public to access the data and information underlying the FDA’s licensure of the Pfizer vaccine, due to widespread and ongoing debate in the medical community about whether the vaccine is “safe and effective,” and due to the “objections of many” regarding current vaccine mandates across the United States.
“This is a great win for transparency and removes one of the strangleholds federal ‘health’ authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program—issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission,” Siri said in a blog post on Jan. 6.
The FDA previously told the judge in December (pdf) that its Center for Biologics Evaluation and Research (CBER), which maintains the records being sought, has just 10 staff in the branch responsible for processing FOIA requests, two of whom are new and “are not yet able to review records at the same rate as more experienced staff members.”
The FDA added it has to make sure it protects certain confidential information as required under the law, as well as protect other information subject to withholding under FOIA exemptions, and so must carefully review the documents on a line by line basis to apply the redactions.
“In sum, FDA’s proposed processing schedule is fair to plaintiff,” the agency argued at the time.