We'll all be dead before FDA releases full COVID vaccine record, plaintiffs say

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

(Reuters) - In advance of a court hearing before a federal judge in Fort Worth, Texas, Tuesday, the Food and Drug Administration has offered by the end of January to make public 12,000 pages of data that it relied on to license Pfizer-BioNTech’s COVID-19 vaccine.

At first glance, that sounds like a lot of material.

Except a group of scientists and doctors who’ve sued the agency under the Freedom of Information Act is seeking an estimated 400,000-plus additional pages of information about the vaccine’s approval. Under the FDA’s proposed schedule – the agency pledges to release “a minimum” of 500 pages a month after the initial dump – the full trove might not be made public until the year 2097.

Or as Aaron Siri of Siri & Glimstad, who represents the plaintiffs Public Health and Medical Professionals for Transparency, put it in court papers, the rate is “so slow that the documents will not be fully produced until almost all of the scientists, attorneys, and most of the Americans that received Pfizer’s product, will have died of old age.”

The FDA, which is represented by lawyers from the Department of Justice, doesn’t dispute in legal filings that it’s obligated to make the vaccine data public. The only issue before U.S. District Judge Mark Pittman, who was appointed to the bench in 2019 by former President Donald Trump, is timing.

The DOJ did not respond to a request for comment. In court papers filed Monday, it suggested that the judge could proceed by approving its 12,000-page offer and “then revisit the issue of a longer-term processing and production schedule with both parties in February 2022.”

I wrote last month about the brewing FOIA fight, when the FDA first revealed it could take 55 years to produce all the responsive documents.

It turns out that there’s even more information responsive to the FOIA request. The plaintiffs estimate that under the agency’s proposed timeline, it could actually take up to 76 years to process and release all of the documents and spreadsheet data they’re seeking.

(This is me banging my head on my desk.)

The plaintiffs want all the information in 108 days – the same amount of time they say it took the FDA to approve the vaccine.

That’s almost surely unrealistic, since the material must first be reviewed to make sure, for example, that no personal information about clinical trial participants or commercial trade secrets are inadvertently revealed.

“It is important for the FDA to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request,” said Suzann Burk, who heads the FDA’s Division of Disclosure and Oversight Management, in a declaration filed with the court.

She estimates that such a close review takes eight minutes per page. She also notes the FDA office that handles FOIA requests has just 10 employees and is swamped with other work, too.

So yes, it’s understandable that the FDA needs some time to produce all the vaccine-related documents. But 76 years?

Pointing to prior FOIA fights, the plaintiffs make a strong argument that the government is capable of moving at least 20 times faster than 500 pages a month.

For example, in Seife v. FDA, they say the agency in 2020 agreed to produce an average of 10,000 pages per month, for a total of 45,000 pages of material in about four months.

The plaintiffs in that case sought information about the testing and approval process for a drug that treats a rare neuromuscular disease – records that Siri writes are “substantially similar to those at issue in this case, many requiring redaction.”

Likewise, in Treatment Action Group v. FDA, which concerned the approval of two hepatitis C drugs, the agency produced 82,668 pages and 1,045 electronic files in about seven months, for an average production rate of 11,800 pages per month.

Why can’t the FDA at least match these rates for producing the COVID vaccine documents?

In court papers, the DOJ argues that the request doesn’t warrant expedited treatment, “particularly in light of the copious information that FDA and other federal agencies have already made public regarding the Pfizer vaccine.” Also, the DOJ argues that the FDA "must handle its substantial volume of FOIA requests equally and fairly."

But Siri, in an emailed comment, called it “dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure.”

To be clear, I’m not interested in casting aspersions on the vaccine. I trust the overwhelming consensus by federal, state and local public health officials that unvaccinated people are more likely to get infected, hospitalized and die of COVID. Personally, I’m relieved to be double-vaxxed and boosted.

But you don’t have to look far to find people who are far more uneasy about the jab.

Indeed, several of the plaintiffs – a group that now includes more than 200 doctors, scientists, professors, public health professionals and journalists from around the world - have publicly questioned the efficacy of lockdown policies, mask mandates and the vaccine itself.

While some members may have their own agendas, the group as a whole has pledged to publish all the information it receives from the FDA on its website and says it “takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses.”

To me, the key issue here is good government and transparency. By slow-walking document production, the FDA fuels suspicions that the vaccine review process was somehow flawed.

A better approach would be to release the information as quickly as possible and use it as an opportunity to assuage the concern of vaccine skeptics.

Opinions expressed here are those of the author. Reuters News, under the Trust Principles, is committed to integrity, independence and freedom from bias.

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Jenna Greene writes about legal business and culture, taking a broad look at trends in the profession, faces behind the cases, and quirky courtroom dramas. A longtime chronicler of the legal industry and high-profile litigation, she lives in Northern California. Reach Greene at jenna.greene@thomsonreuters.com