Members of Public Health and Medical Professionals for Transparency and U.S. Food & Drug Administration officials are at odds in the court this week, as revealed by a joint report filed on Monday. FDA received a Freedom Of Information Act (FOIA) request to release all Pfizer COVID vaccine data.
The plaintiff in the case is Public Health and Medical Professionals for Transparency, a nonprofit organization of medical and public health professionals, scientists, and journalists. According to their website, the organization exists for the sole purpose of obtaining and disseminating the data the FDA referenced when licensing a COVID vaccine.
After the Pfizer COVID vaccine was approved for ages sixteen and up, the organization submitted a Freedom of Information Act (FOIA) request to the FDA, the defendant in the case, requesting all of the data they used when approving the Pfizer vaccine.
When the FDA did not produce the documents within the required time, the nonprofit sued the FDA in the United States District Court for the Northern District of Texas.
The nonprofit asserts that because so many Americans’ ability to participate in society is contingent upon receipt of the COVID vaccine, “basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available.”
They also consider transparency regarding the vaccine even more important because Health and Human Services has eliminated individuals’ ability to seek financial recourse against Pfizer if patients suffer an adverse reaction from the vaccine. With this in mind, they believe the public must have access to the documents and data Pfizer submitted when they sought licensing.
Public Health and Medical Professionals for Transparency summarized their stance, “We assume, as the FDA has stated, that it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. The FDA now has an equally important task of making those documents available to the plaintiff in this case and the public at large in at least the same timeframe.”
According to the filing, the FDA intends to comply with the request for the information. However, they asked the court to rule on a schedule for processing the records, which the nonprofit initially requested to be released by March 3, 2022.
The complaint says, “The FDA’s own regulations thus expressly recognize the importance of having the data and information relied upon to license a vaccine ‘immediately available for public disclosure.’ […] The FDA’s regulation not only supports the need for expedited treatment under FOIA but is also an independent legal basis that requires expedited treatment of the FOIA Request.”
The FDA claims that the plaintiffs need to agree to a processing schedule because they cannot fully hand over the Pfizer COVID vaccine documents immediately. The agency must review the documents and redact information exempt from the FOIA, a process that can require government information specialists to go through records line by line.
They also claim that when large amounts of information are requested, like in this case, “courts typically set a schedule whereby the processing and production of the non-exempt portions of records is made on a rolling basis.”
The FDA claims that more than 329,000 pages could be considered a response to the FOIA request. They claim this number is actually “under-inclusive” because “it does not include certain types of records that cannot be meaningfully paginated, such as data captured in spreadsheets that contain thousands of rows of data.”
Considering this information, the Public Health and Medical Professionals for Transparency’s request that the FDA release the non-exempt portions of more than 329,000 pages in four months would require the FDA to process more than 80,000 pages a month.
The FDA also claims that being made to produce these materials under such a time constraint increases the risk of making mistakes. Hasty action can lead to errors, including the release of sensitive information exempt from the FOIA, confidential business and trade secret information, or patients’ private personal information.
Additionally, the FDA states it does not have the personnel or resources in its FOIA office to process more than 80,000 pages in a month. It has a total of ten employees, a number that includes the director and two trainees.
They also claim that privileging this particular FOIA request would mean monopolizing all of the FDA’s resources, preventing efficient response to all other requests.
Due to the overwhelming number of documents requested in the FOIA, the FDA proposes that they be permitted to “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month,” a rolling basis consistent with processing schedules across the country in FOIA cases.
However, at that rate, it would take 55 years to release all relevant information. They would not have all the information turned over until the year 2076.
In a second joint report filed, Public Health and Medical Professionals for Transparency argue “If the FDA claims its obligations under FOIA are too burdensome, it should take its complaints to Congress – not this Court.”
The Court has not yet ruled on a processing schedule to settle the opposing timeframes the FDA and the nonprofit organization have requested.