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The U.S. Food and Drug Administration (FDA) last week asked a Texas court to shut down a lawsuit seeking documents related to the FDA’s licensing of Pfizer’s Comirnaty COVID-19 vaccine for ages 16 and up.
Public Health and Medical Professionals for Transparency (PHMPT) — a group of more than 30 medical and public health professionals and scientists from Harvard, Yale, UCLA and other institutions — sued the FDA in Sept 2021, after the agency failed to respond to a Freedom of Information Act (FOIA) request for “all data and information for the Pfizer Vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.
The case is being heard in the U.S. District Court for the Northern District of Texas.
On Oct. 17, the FDA filed a motion to throw out the lawsuit, arguing that the agency had “complied with its obligations under FOIA” by conducting a “good faith search that was reasonably calculated to uncover all responsive records.”
The FDA said it spent more than $3.5 million to produce over 1 million Pfizer documents for the case, Reuters reported. However, critics accused the FDA of withholding key information.
“Despite years of litigation, and the Court’s order to produce all clinical trial documents, FDA continues to improperly withhold over a million pages of trial documents,” Aaron Siri, attorney for the plaintiffs, told Reuters.
Sasha Latypova, a former pharmaceutical industry executive with 25 years of experience in pharmaceutical research and development, told The Defender the documents released so far by the FDA are “inadequate” to assess the quality of Pfizer’s COVID-19 vaccine manufacturing process.
Of the more than 1 million pages produced by the FDA in response to the lawsuit, there should have been thousands of pages of manufacturing documents, she said. “Yet, almost none have been produced.”
Latypova said:
“There are several documents that became public after a leak from the European Medicines Agency in late 2020 that included Pfizer’s extensive communication with the FDA responding to queries on manufacturing process quality control.
“These documents have not been included in the FDA production in this lawsuit. The FDA should explain why.”
It’s important that the FDA release all manufacturing documents because the public deserves “assurances that the manufacturing process is high quality and rigorously controlled,” Latypova said.
Yet the FDA released “almost no documentation” from Module 3 of Pfizer’s Biologics License Application. Latypova explained:
“Module 3, or Chemistry Manufacturing Controls documentation, typically comprises approximately 20-30% of the new drug or biologics application as it deals with the manufacturer’s ability to demonstrate that their process ensures purity, potency and lack of contaminants in the final product as dispensed to the patient.
“Since there have been numerous reports, including in peer-reviewed publications, that Pfizer’s Comirnaty product is contaminated with non-conforming microRNA, DNA plasmids, SV40, different metals, protein, micro- and macro- objects in the vials — there are significant concerns with the manufacturing process failures.”
‘FDA has attempted to stonewall production at every turn’
The FDA’s recent filing pertains to one of two FOIA lawsuits PHMPT filed related to COVID-19 vaccines. One sought documents related to Pfizer’s shot for ages 16 and up. The other sought documents related to Moderna and Pfizer’s shot for ages 12-15.
In the Pfizer 16 and up case, FDA lawyers told U.S. District Judge Mark Pittman the agency should be allowed to disclose the data slowly over 75 years, arguing that its small staff team needed a lot of time to redact trade secrets and personal information and could only release 500 pages a month.
However, Pittman on Jan. 6, 2022, ordered the FDA to hand over the files at a rate of 55,000 pages every 30 days over roughly eight months.
Since the court order, the batches of documents released by the FDA have shown concerning facts. For example, a cache released in May 2022 showed Pfizer classified many adverse events in its clinical trials as “unrelated” to the vaccine.
A batch released in December 2023 revealed the agency knew its product safety monitoring system was “not sufficient” for assessing the risk for myocarditis and pericarditis following vaccination.
Commenting on the FDA’s resistance to releasing documents, Kim Mack Rosenberg, Children’s Health Defense (CHD) general counsel, told The Defender, “Plaintiffs in this case have been fighting for years to obtain disclosure of these critical documents and FDA has attempted to stonewall production at every turn.”
Was FDA’s search ‘adequate’?
PHMPT said in an Oct. 1 filing related to the Pfizer 16 and up case that it was waiving the right to challenge the FDA’s redactions and withholdings in the documents produced so far — that leaves whether the FDA conducted an adequate search as the only remaining issue, according to Reuters.
The FDA contends its search satisfied its legal obligation under FOIA. Mack Rosenberg disagreed. “The FDA is flat out attempting to avoid its legal obligations to produce materials under the Freedom of Information Act.”
The Freedom of Information Act exists to promote government transparency, Mack Rosenberg said. “Government actions during the COVID-19 pandemic raised serious questions of — among other things — agency responsibility, agency capture and agency ability to properly carry out its functions.”
“Whether the FDA engaged in improper actions (or inaction) in approving COVID-19 vaccines is vitally important both in understanding and making the public aware of what happened in the past and to prevent this from happening again,” she added.
Ray Flores, senior outside counsel for CHD, told The Defender the plaintiffs are expected to file a motion on Nov. 7 challenging the adequacy of the FDA’s search. He said he doesn’t expect the judge to toss out the case when “such a dispute remains.”
He added, “Once the court resolves this matter in 2025, I expect the plaintiffs will thoroughly review the documents provided and will file a new FOIA request to challenge any documents the FDA improperly redacted or withheld.”
The FDA did not immediately respond to The Defender’s request to comment.
From dailyclout.io
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