Opinion

FDA Seeks Court’s Permission to Delay Release of Pfizer Documents

In a move that is not all too surprising considering the previous absurd requests, the Food and Drug Administration (FDA) has asked for more time than what the court ordered to release Pfizer documents.

As many will recall, a group called Public Health and Medical Professionals for Transparency (PHMPT) submitted a Freedom of Information Act (FOIA) request to the FDA last summer for “all data and information” related to adverse events and safety and effectiveness of the Pfizer Comirnaty shot. The FDA approved Comirnaty last August, but it is not in use with only Emergency Use Authorization experimental jabs currently available.

The FDA did not respond to the FOIA request prompting a lawsuit in which PHMPT wanted full release of documents in 108 days, “the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine.”

In response, the FDA shockingly asked to be given until 2076 to fully release the documents and then doubled down to delay until 2096 for full release. The FDA wanted to release 500 pages a month, but a Jan. 6 ruling by U.S. District Judge Mark T. Pittman required 50,000 pages a month meaning full release would be in 8 months.

According to PHMPT lawyer Aaron Siri, the FDA this week asked for delays with a motion to modify the scheduling order, and they have help from Pfizer lawyers.

Siri wrote on Substack:

“Since the government has trillions of dollars of our money, it is putting it to good use by fighting to assure that the public has the least amount of transparency possible. To that end, it has now asked the Court to make the public wait until May for it to start producing 55,000 pages per month and, even then, claims it may not be able to meet this rate.”

“The FDA’s excuse? As explained in the brief opposing the FDA’s request, the FDA’s defense effectively amounts to claiming that the 11 document reviewers it has already assigned and the 17 additional reviewers being onboarded are only capable of reading at the speed of preschoolers.”

In a Jan. 24 court brief filed by PHMPT’s lawyers opposing the FDA’s request, it states that the FDA wants to delay the 55,000 pages a month court order until May 1. Under the Jan. 6 ruling, the FDA was to produce 12,000 pages by the end of this month and then follow the 55,000 pages a month starting in February. The FDA has 11 full-time staff working on reviewing the documents and admits that, under private industry standards, they should be able to produce 88,000 pages a month.

However, the FDA wants to produce just 10,000 pages a month until May meaning a rate of just five pages an hour among 11 full-time staff.

“It is understandable that the FDA does not want independent scientists to review the documents it relied upon to license Pfizer’s vaccine given that it is not as effective as the FDA originally claimed, does not prevent transmission, does not prevent against certain emerging variants, can cause serious heart inflammation in younger individuals, and has numerous other undisputed safety issues,” the brief states. “However, the FDA’s potential embarrassment over its decision to license this product must take a back seat to the transparency demanded by FOIA and the urgent need and interests of the American people to review that licensure data. The Court already recognized this unprecedented urgent need in its January 6th order directing the FDA to produce 55,000 pages per month.”

The brief goes on to state that this request, coming just weeks after the ruling, “is just the start of a campaign to delay the production ordered by the court,” and it adds:

“The Court is, other than Congress, the only check on the FDA. In a free country, transparency is paramount, and the FDA has chosen to thwart transparency and the requirements of FOIA by anemically understaffing the office it maintains to respond to FOIA requests. It is akin to the boy that kills his parents and asks for sympathy for being an orphan. Decrying that this Court is now making it comply with the law — by actually producing documents in a timely manner — is ridiculous.”

Meanwhile, Pfizer apparently wasn’t happy with the government’s lawyers as it’s thrown its weight into the case.

“As the FDA tries to obtain months of delay, guess who just showed upon in the lawsuit? Yep, Pfizer,” Siri wrote. “And it is represented by a global chair and team from a law firm with thousands of lawyers. Pfizer’s legal bill will likely be multiple times what it would cost the FDA to simply hire a private document review company to review, redact, and produce the documents at issue. Within weeks, if not days.”

Siri added: “Pfizer is coming in as a third party. But Pfizer assures the Court it is here to help expedite production of the documents. Sure it is! Where was Pfizer before the Court ordered the 55,000 pages per month? Right, doing what it normally does: letting the government work on its behalf — like the way the government mandates, promotes, and defends Pfizer’s product.”

PHMPT has posted an updated page with documents already released. The most recent release of documents came on Jan. 18.

Content syndicated from TheLibertyLoft.com with permission.

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