Wait what? FDA wants 55 years to process FOIA request for vaccine data

The headquarters of the Food and Drug Administration (FDA) in White Oak, Maryland on August 29, 2020. REUTERS / Andrew Kelly

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(Reuters) – Freedom of Information Act requests are rarely swift, but when a group of scientists asked the federal government to share the data it relied on to clear Pfizer’s COVID-19 vaccine, the response went beyond mere bureaucratic drag.

As in 55 years beyond.

That’s the length of time the Food & Drug Administration in court documents is proposing this week that it should be given to review and release the treasure trove of vaccine-related documents meeting demand. If a Texas federal judge agrees, plaintiffs, Public Health and Medical Professionals for Transparency, can expect to see the full case file in 2076.

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The FOIA Act of 1967 requires federal agencies to respond to requests for information within 20 business days. However, the time it takes to obtain the documents “will vary depending on the complexity of the application and any backlog of applications already pending at the agency,” according to the central government website FOIA.

Department of Justice attorneys representing the FDA note in court documents that plaintiffs are seeking an enormous amount of vaccine-related material – approximately 329,000 pages.

The plaintiffs, a group of more than 30 professors and scientists from universities including Yale, Harvard, UCLA and Brown, filed a lawsuit in September in U.S. District Court for the Northern District of Texas, asking for expedited access to the records. They say the release of the information could help reassure vaccine skeptics that the vaccine is indeed “safe and effective, and thus increase confidence in the Pfizer vaccine.”

But the FDA can’t just hand over the documents in bulk. Records should be reviewed to redact “confidential business information and trade secrets of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” DOJ lawyers wrote in a report. joint situation filed Monday.

The FDA proposes to publish 500 pages per month on an ongoing basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests.

“By processing and making interim responses based on 500-page increments, the FDA will be able to deliver more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources and where fewer Plaintiffs’ demands are met. ”Justice Department attorneys wrote, pointing to other court rulings where the 500-page-per-month schedule has been upheld.

Civil Division trial attorney Courtney Enlow referred my request for further comment to the Department of Justice public affairs office, who did not respond.

Lawyers for the plaintiffs argue their request should be the top priority and that the FDA should release all material by March 3, 2022.

“This 108-day period is the same time it took the FDA to review the reactive documents for Pfizer’s much more complex COVID-19 vaccine licensing task,” Siri & Glimstad’s Aaron Siri wrote in New York and John Howie of Howie Law in Dallas in court papers.

“The goal of FOIA is to ensure government transparency,” they continued. “It is difficult to imagine a greater need for transparency than the immediate disclosure of the documents invoked by the FDA to authorize a product which is now mandated to more than 100 million Americans on pain of losing their careers, their income, their military service status., and much worse.

They also argue that Title 21, Subchapter F of the FDA’s own regulations states that the agency “shall make” immediately available “all documents underlying the authorization of a vaccine.”

Given the intense public interest in the vaccine, lawyers for the plaintiffs say the FDA “should have prepared to release (the data) along with the licensing.” Instead, he did the opposite.

Siri declined to comment.

To meet the FOIA deadline proposed by the complainants, the FDA would need to process 80,000 pages per month. But the complainants note that the FDA has 18,000 employees and a budget of $ 6 billion and “has itself said that there is nothing more important than the authorization to exercise this vaccine and to be transparent about this vaccine ”.

To be sure, most people – including those who vehemently proclaim “I’m doing my own research” – don’t have the expertise to assess information.

But the plaintiffs, which also include foreign professors from the UK, Germany, Denmark, Australia and Canada, appear to be in a good position to do so.

As Siri and Howe argue, “Reviewing this information will resolve the ongoing public debate regarding the adequacy of the FDA review process. “

U.S. District Judge Mark Pittman has scheduled a December 14 scheduling conference in Fort Worth to review the document processing schedule.

The opinions expressed here are those of the author. Reuters News, under the principles of trust, is committed to respecting integrity, independence and freedom from bias.

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The opinions expressed are those of the author. They do not reflect the views of Reuters News, which, under the principles of trust, is committed to respecting integrity, independence and freedom from bias.

Jenna greene

Jenna Greene writes about legal business and culture, examining trends in the profession, the faces behind business and the quirky courtroom dramas. A longtime legal industry and high-profile litigation columnist, she lives in Northern California. Contact Greene at [email protected]


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