Does the FDA want to release vaccine data by 2076?

Summary: A planning dispute related to a Freedom of Information Act (FOIA) request for more than 329,000 pages of COVID-19 vaccine data led to misleading social media posts in November 2021. The US Food and Drug Administration (FDA) proposed a treatment schedule and releases 500 pages each month, arguing that this is the standard rate for processing FOIA requests, as “reviewing and editing exempt information records is a time-consuming process.” The FDA would begin releasing this data immediately, but the full set of pages would not be processed until 2076. The FDA claimed that the time required to fulfill this request is due to the broad FOIA request involving hundreds of thousands of pages.

In November 2021, a rumor began circulating on social media that the US Food and Drug Administration (FDA) was trying to “hide” data related to the COVID-19 vaccine and that they had requested to postpone the release of relevant information. until 2076.

The FDA did not request a delay in the release of its COVID-19 data before 2076. The FDA responded to a Freedom of Information Act (FOIA) request for more than 300,000 pages of data related to the licensing of Pfizer’s COVID-19 data. vaccine of proposes a treatment plan that would see the release of 500 pages each month. While the FDA claims that this is a fairly standard treatment plan, it will take the FDA more than 50 years, or until 2076, to comply with it, if complied with.

A FOIA request

This claim stems from a FOIA request filed by Public Health and Medical Professionals for Transparency for the data the FDA relied on to license Pfizer’s COVID-19 vaccine. While the government is required to respond to these requests, the time it takes to fulfill these requests varies depending on the number of documents requested, the backlog of the responding agency, and the complexity of the documents involved. The U.S. Department of Justice wrote:

Agencies typically process requests in the order in which they are received. The time it takes to respond to a request will vary depending on the complexity of the request and any backlog of requests already pending at the agency. A simple request can be processed faster by the agency than one that is complex. Simple requests are typically more targeted and seek fewer pages of records. Complex requests typically seek a large amount of material or require additional steps to process, such as the need to search for items in multiple locations. The Agency’s FOIA Requester Service Center is available to assist you with any question regarding the status of your request and any steps you may take to obtain a faster response.

On November 15, 2021, the FDA and Public Health and Medical Professionals for Transparency submitted a joint report to the U.S. District Court for the Northern District of Texas and are now awaiting the court to decide on a schedule for the release of these documents.

Arguments of the applicant: 108 days

The Public Health and Medical Professionals for Transparency (plaintiff) argued that the FDA should release these documents by March 3, 2022. The plaintiff chose this date as it gives the FDA 108 days, the same time it took the agency to review the data to license Pfizer’s COVID-19 vaccine.

The applicant wrote:

Plaintiff seeks the records that Pfizer has submitted to the FDA for licensing its COVID-19 vaccine (the “FOIA Request”) and requests an order requiring the FDA to provide all documents in accordance with its FOIA request. no later than March 3, 2022. This 108-day period is the same time it took the FDA to review the responsive documents for the far more complicated task of licensing Pfizer’s Covid-19 vaccine (the “Pfizer vaccine”).

[…]

It took the FDA exactly 108 days, from the time Pfizer began producing the licensing records on May 7, 202114, until the product was approved on August 23, 2021. We assume, as the FDA has stated, that it implemented an intense, robust, thorough and complete review and analysis of these documents to ensure that the Pfizer vaccine was safe and effective for licensing. The FDA now has an equally important task of making these documents available to the plaintiff in this case and to the public at large within at least the same time frame.

The plaintiff went on to argue that the release of these documents is of paramount importance, as “a majority of Americans’ ability to participate in civil society and even exercise fundamental freedoms is now conditional on receiving this product.”

A majority of Americans’ ability to participate in civil society and even exercise fundamental freedoms is now conditional on receiving this product. For example, the White House’s recent Covid-19 action plan and executive orders have made the receipt of this product a condition of employment for more than 6 million federal workers and contractors, 22 million health professionals, 84 million private sector employees and recruits, and reserve members of our armed forces. There are few whose livelihood, education, service and participation in civil society are not subject to a government requirement to receive this product. On this basis alone, fundamental freedom and government transparency require that the documents and data submitted by Pfizer to license this product be made immediately available to the plaintiff and the public, exactly as provided for by federal rules.

FDA’s argument: 500 pages per month

The FDA claimed in the joint report that the plaintiff’s request covers more than 329,000 pages and that reviewing and editing these records would be a time consuming process. The FDA proposed a schedule to process and release 500 pages per month, a rate that they claimed is in line with FOIA request processing plans.

The FDA wrote:

Reviewing and editing exempt information registers is a time-consuming process that often requires public information specialists to review each page line by line. When a party requests a large amount of records, as the plaintiff did here, the courts typically set a schedule where the processing and production of the non-exempt portions of records takes place on an ongoing basis.

[…]

The FDA has estimated that there are more than 329,000 pages that potentially respond to plaintiff’s FOIA request. […] The FDA proposes to review the list of documents that Plaintiff requested the FDA to prioritize for production in order of priority and process and to release the non-exempt portions of these records to Plaintiff on an ongoing basis. The FDA proposes to process and produce the non-exempt portions of responsive records at a rate of 500 pages per second. month. This rate is in line with treatment plans entered by courts across the country in FOIA cases.

The FDA also addressed the plaintiff’s request to process this FOIA request at the same time as the agency reviewed the data prior to licensing Pfizer’s COVID-19 vaccine, calling this a “significant argument” as these two review processes are not comparable.

The court should flatly reject the plaintiff’s bizarre argument that because the scientists reviewing Pfizer’s Biologics License Application could do so within an expedited time frame, government information specialists should be able to do so in the same amount of time. As it should be clear, the review that FDA researchers perform when considering approving a product is quite different from the review that FDA government information specialists conduct when considering whether the FDA should keep certain information confidential. Moreover, the FDA’s FOIA office does not have nearly the same level of personnel or resources dedicated to processing FOIA requests, as the FDA has set out to review license applications for life-saving products in the midst of a pandemic.

It should also be noted that while many on social media claimed that the FDA wanted to “postpone” the release of data until 2076, the agency’s proposed schedule will see data begin to be released almost immediately. Although it would take years for this entire FOIA request to be met, the FDA claimed that this was due to the plaintiff’s broad request:

Although the plaintiff is in doubt as to how long it will take to process 329,000 pages at a speed of 500 pages per page. month, such a result is due to its own broad FOIA request. Courts do not waive the standard processing speed of 500 pages per second. month, even when a FOIA request would take years to process … The FDA has invited Plaintiff to narrow its request by specifying records that it no longer wants the FDA to process and release, and Plaintiff has refused to do so. . If Plaintiff decides to request fewer records, the FDA will be able to terminate processing at an earlier stage.

When will this data be released?

While the FDA claimed that processing 500 pages a month is standard for a FOIA request, public authorities have been tasked with processing documents at much faster speeds when dealing with particularly important or time-sensitive issues. In 2019, for example, U.S. District Judge Paul Englemayer ordered the U.S. Department of State and Secretary of Defense to produce 5,000 pages a month to fulfill a FOIA request related to the murder of journalist Jamal Khashoggi:

Federal agencies must produce thousands of pages a month with records regarding the assassination of Saudi dissident Jamal Khashoggi, because learning about his disappearance as soon as possible is “of paramount importance,” a judge said Tuesday.

Representatives of the U.S. State Department and Department of Defense had told U.S. District Judge Paul A. Engelmayer that producing 5,000 pages a month makes it impossible to respond in a timely manner to other requests from the Freedom of Information Act.

Engelmayer ordered the agencies to get it done anyway, saying the disappearance of the Washington Post columnist and Saudi citizen was of “significant public significance.”

According to Reuters, this planning dispute is likely to be settled next month: “U.S. District Judge Mark Pittman” has set a planning conference for Dec. 14 in Fort Worth to consider the timeline for processing the documents. “


Sources:

Law (FOIA), Freedom of Information. FOIA.Gov (Freedom of Information Act) Frequently Asked Questions (FAQ). https://www.foia.gov/faq.html. Accessed November 19, 2021.

Gonzales, Richard. “Federal judge orders release of Khashoggi records by US government.” NPR, August 6, 2019. NPR, https://www.npr.org/2019/08/06/748877181/federal-judge-orders-release-of-khashoggi-records-by-us-government.

Siri, Aaron. “The FDA is asking a federal judge to grant it until the year 2076 to fully release Pfizer’s COVID-19 vaccine data.” Injecting Freedom, November 17, 2021, https://aaronsiri.substack.com/p/fda-asks-federal-judge-to-grant-it.

“Wait, what? The FDA will have 55 years to process FOIA requests for vaccine data.” Reuters, November 18, 2021, https://www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18 /.

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