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FDA says 55 years to process request for extensive vaccine data under Freedom of Information Act

A group of 30 scientists and professors wants the FDA to provide documentation about the licensure of Pfizer's COVID vaccine by March 2022.

The Food and Drug Administration suggests it will take the agency 55 years to answer a Freedom of Information Act (FOIA) request for data related to the licensing of Pfizer's COVID-19 vaccine. That's according to a joint court filing with both parties Monday.

FOIA has existed since 1967. It allows the public to request records from any federal agency, unless the information falls under certain exemptions including personal privacy.

The plaintiffs, called the Public Health and Medical Professionals for Transparency, are made up of more than 30 professors and scientists from Ivy League schools and UCLA. It is asking the FDA to respond to its FOIA request by March 3, 2022. The group says that's 108 days — the same amount of time it says the FDA took to review and license the vaccine earlier this year.

"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 group said in the joint filing. 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."

The FDA said in its part of the court filing that there are more than 329,000 pages that may be part of the FOIA request. The agency said that would be 80,000 pages per month to meet the proposed deadline. 

Part of the issue, it claims, is that the FDA office that would need to do the work has ten employees, including two trainees, and is currently processing about 400 FOIA requests. It also says the process is time-consuming as each page must be reviewed "line-by-line" and some information exempt from FOIA would need to be redacted.

The FDA said the standard would be to release 500 pages per month on a rolling basis — 6,000 pages per year. Divide 329,000 by 6,000 and the result is 54.83 years.

At that pace, the request wouldn't be fully answered until 2076.

"Courts do not waiver from the standard 500 page per month processing rate even when a FOIA request would take years to process," the FDA said.

The FOIA website states complex requests typically take more time than simple ones, but they can be expedited if a slower response "could reasonably be expected to pose a threat to someone’s life or physical safety" or if there is an urgency to inform the public about federal government activity.

The scientists and professors said vaccines have become a requirement for employment in many cases.

"There are few whose livelihood, education, service, and participation in civil society are not contingent on a government requirement to receive this product," the group said. "On this basis alone, basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available to Plaintiff and the public forthwith, precisely as contemplated by federal regulations."

The FDA is requesting a conference with the court to schedule the release of the documents. Reuters reports U.S. District Judge Mark Pittman has set a Dec. 14 hearing in Fort Worth, Texas, to discuss the release schedule.

An email to the plaintiff's attorneys Thursday night for further comment had not been replied to by Friday afternoon. The FDA responded to a similar email, saying it does not comment on ongoing litigation.

The CDC said Friday 68.8% of Americans had received one dose of either the Pfizer, Moderna or Johnson & Johnson vaccines, with 58.9% being fully vaccinated and 16.6% having received a booster.

The FDA and the Centers for Disease Control and Prevention authorized vaccine boosters for all adults Friday.  CDC Director Dr. Rochelle Walensky also endorsed adding a recommendation that all people 50 and older should be urged to get a booster.

Editor's note: The author of this article is not related to Judge Mark Pittman, who is hearing the case.

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