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The not-for-profit group suing the US Food and Drug Administration for releasing documents related to the approval of Pfizer’s Comirnaty vaccine has calculated that, with 19 full-time reviewers, the agency only needed 12 weeks to review and prepare the documents should.

U.S. Food and Drug Administration (FDA) officials skipped the start of the hearing on Tuesday as a federal district court weighed whether the agency could take 75 years to fully release documents about Pfizer’s Comirnaty COVID vaccine, according to an attorney , representing plaintiffs who sued the FDA over the documents.

A US Department of Justice attorney representing the FDA told the US District Court for the Northern District of Texas that the agency will produce more than 329,000 related documents as soon as possible, protecting personal information and trade secrets from Pfizer have to.

The Public Health and Medical Professionals for Transparency (PHMPT) group behind the Freedom of Information Act (FOIA) and subsequent lawsuit is demanding safety and efficacy data, reports of adverse effects, and a list of active and inactive Vaccine ingredients.

PHMPT is a group of more than 30 scientists, medical professionals, international public health professionals and journalists. The group’s lawsuit argues that the FDA is overestimating the time required and the work is understaffed.

“Assuming a low average of 50 pages per hour per person, even to review the hundreds of thousands of pages it estimates, the FDA would only need 19 people working full-time for 12 weeks to review and review those documents create – that’s only a tiny fraction of their approximately 18,000 employees, “said PHMPT in a brief submitted on Monday.

The day before the hearing, the FDA released 14 documents, the largest of which was 2,030 pages. PHMPT has published an updated list showing the documents released since November 17th.

FOIA does not prescribe a specific processing schedule, just that the agency must process requests “as quickly as possible,” according to the FDA in a brief filed on Monday.

Basically, the question of which processing schedule is “practicable” for the agency remains, ”the FDA said.

At the agency’s proposed rate of 500 documents per month, the last documents would be released in 2096.

A quote from Business Intelligence Associates, an e-discovery company, estimated 400,000 pages could be created in six to eight weeks at a cost of $ 132,000, according to PHMPT.

PHMPT requests FDA documents to be released within 108 days. That’s the same amount of time it took the FDA to review the documents for the far more complicated task of “licensing Pfizer’s vaccine,” the group said in their lawsuit.

Attorney Aaron Siri, who represents PHMPT, said:

“Americans are routinely required to produce documents, pay fines, and expend other resources to comply with the law. The courts do not ask about the ability or financial resources to comply with the law – they must comply.

“Indeed, it would be ridiculous for a billionaire defendant to come to court and plead poverty to avoid submission, but that is the FDA’s position.”

The FDA’s 2019 fiscal year budget is $ 6.1 billion.

In the FDA’s 64-page briefing, the agency argued that, out of “fairness” to other FOIA applicants, they needed the full 75 years to redact and release the documents.

The PHMPT defined fairness differently in its response letter:

“Fairness would be to reassure the millions of Americans who are about to receive this liability-free vaccine today about the FDA’s review by giving independent scientists access to the same data the FDA reviewed without making them wait decades.

“Fairness would mean that Americans who have been harmed by the vaccine today and cannot sue Pfizer or anyone else for the harm, can hope that with access to this data, independent scientists can more easily develop treatments for their ailments.

“It would be fair if our federal health authorities gave more than one person a few hours each month to review Pfizer’s documents with a view to making them available to the public after Pfizer spent over $ 17 billion in taxpayers’ money to develop and commercialize the Product received.

“That would be fair to the American people.”

Siri noted that the court has not yet made a decision and that a transcript of the hearing will be released soon this week.

US MP Ralph Norman (RS.C.) tabled bill earlier this month that would force the FDA to release it within 100 days.


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