Responding to a Freedom of Information Act (FOIA) request made back in August, the U.S. Food & Drug Administration told a federal judge it first wants to take 55 years to review the data it used in licensing Pfizer’s COVID-19 vaccine.
Reuters reports the FDA request came to light this week in court papers responding to the FOIA inquiry. If a federal judge in Texas agrees, plaintiffs Public Health and Medical Professionals for Transparency (PHMPT) can expect to see the full record in 2076.
According to its website, PHMPT is a non-profit organization “made up of public health professionals, medical professionals, scientists, and journalists.” They say their group “exists solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines.”
The data the group is seeking refers to the FDA’s decision to license what is now known as the Comirnaty vaccine against COVID-19, produced by Pfizer in collaboration with BioNTech, according to Israel National News.
In both November of 2020, and in September of 2021, the agency committed to its transparency in writing.
“As we learn more about the safety and effectiveness of COVID-19 vaccines… we will continue to evaluate the rapidly changing science and keep the public informed,” the FDA wrote in September.
According to the government’s USGS website, normal requests are usually processed in six to 20 workdays.
But the time it takes to get the actual documents “will vary depending on the complexity of the request and any backlog of requests already pending at the agency,” according to the website.
329,000 Pages of Material
U.S. Justice Department lawyers representing the FDA noted in court documents that the plaintiffs are seeking more than 329,000 pages of material.
After waiting a month without any response from the FDA on their FOIA request, PHMPT filed a lawsuit in September in the U.S. District Court for the Northern District of Texas, asking for expedited access to all of the material.
But the FDA says the documents must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” DOJ lawyers wrote in a joint status report filed Monday.
In its response, the FDA said it was willing to process and release 500 pages a month.
The “FDA proposes to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month,” at which rate the entire body of data it intends to release (which is only the non-exempt portions) will not be released before the year 2076.”
The FDA’s lawyers also noted, “the FDA does not have the personnel or resources in its FOIA office to process Plaintiff’s FOIA request at a rate of more than 80,000 pages per month.” The documents note the FDA branch that would handle the review of the documents only has 10 employees and is currently processing about 400 other FOIA requests.
“By processing and making interim responses based on 500-page increments, FDA will be able to provide more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources and where fewer requesters’ requests are being fulfilled,” the agency’s lawyers wrote.
Why 55 Years if It Only Took 108 Days to Approve the Vaccine?
However, PHMPT attorneys countered their request should be given priority by the agency and it should release all of the documents no later than March 3, 2022.
“This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine,” the attorneys wrote in their rebuttal.
“The entire purpose of the FOIA is to assure government transparency,” they continued. “It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.”
U.S. District Judge Mark Pittman has set a scheduling conference for Dec. 14 in Fort Worth to consider the timeline for processing the documents, according to Reuters.
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