Judge Rules Against Pfizer, Must Provide Documents Now, Not in 75 years

OPINION: This article contains commentary which may reflect the author's opinion

On Thursday, a federal judge in Texas ordered the Food and Drug Administration to release all information about Pfizer’s COVID-19 vaccine in an accelerated timetable. The judge imposed an eight-month timeline under which all the data will be released.

In other words, that would be 75 years and four months faster than the FDA said it would take to process a Freedom of Information Act request from a group of doctors and scientists for an estimated 450,000 pages of vaccine information.

The court “concludes that this FOIA request is of paramount public importance,” wrote U.S. District Judge Mark Pittman in Fort Worth. Pittman was appointed by President Trump in 2019.

FDA did not contest that it had a responsibility to make the information public but argued that its short-staffed FOIA office could only handle the review and release of 500 pages a month.

Although Pittman acknowledged “the ‘unduly burdensome’ burden this FOIA request might pose to the FDA,” but in his four-page ruling, Pittman rejected the FDA’s scheduling proposal.

His order was to turn over 55,000 pages per month instead of 500 pages a month – the FDA’s original proposal. So, all vaccine data from Pfizer should be available to the public by the end of the summer rather than in 2097, for example.

By expediting the document production, Pittman did the FDA and the country a huge favor, though it may not seem that way to the FDA.

In many eyes, the FDA’s proposed timeline seemed strange, perhaps even nefarious.

In his order, Pittman cited the late John McCain, who said excessive government secrecy “feeds conspiracy theories and reduces the public’s confidence in the government.”

Nonetheless, the FDA may have difficulty processing 55,000 pages per month.

Suzann Burk, the head of the FDA’s Division of Disclosure and Oversight Management, informed the court earlier this year that her office reviews FOIA requests with just 10 employees. According to Burke, it takes a worker eight minutes per page to review all requests for information in detail.

If the employees worked non-stop 24 hours a day, seven days a week, they would still fall a little short of the 55,000 pages per month.

In court papers, however, the lawyers for the plaintiffs Public Health and Medical Professionals for Transparency highlighted that the FDA had 18,062 employees as of 2020. It is certainly possible that some of them can help out at the FOIA office.

In an email, Aaron Siri, the plaintiffs’ lawyer, said that the decision “came down on the side of transparency and accountability.”

In addition to doctors, scientists, professors, and public health professionals, his clients have pledged to publish all that they receive from the FDA on their website. Some, however, have publicly questioned the safety of lockdown policies, mask mandates, and the vaccine itself.

A request for comment from the Justice Department, which represented the FDA, was not immediately returned on Thursday evening. Pfizer did not respond immediately when contacted for comment, even though the company is not a party to the suit.

According to Pittman, the FOIA request must be a priority for the FDA, even if it is burdensome.

Pittman quoted some of the remarks made in the hearing. “There may not be a ‘more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated,” and assuring the public that the vaccine was not “‘rush[ed] on behalf of the United States,'” He wrote.

The ruling comes as the Supreme Court is hearing cases against Biden’s vaccine mandates.

As a result of the highly contagious Omicron variant, more than 100,000 Americans have been hospitalized for COVID-19, and the Supreme Court will hear oral arguments on Friday regarding two set of challenges to the Biden administration’s authority to take action to combat the pandemic. Supreme Court justices will consider the Biden administration’s attempt to mandate vaccines or lab testing for large employers in the first case, National Federation of Independent Businesses v. Department of Labor. Second, in Biden v. Missouri, health care workers at institutions receiving federal funding will be required to receive vaccines.

It was an emergency matter brought to the court last month, which would have generally led to the justices disposing of it with a quick order and without hearing arguments. Instead, the justices scheduled oral arguments for Jan. 7 on whether mandates can remain in place while challenges to their legality are ongoing in lower courts. The justices transferred highly charged and time-sensitive matters off of the so-called shadow docket and onto the merits docket for full briefing and argument for the third time this term.

It is expected that the arguments will last at least two hours. It is expected that at least 100 million workers will be affected by the ruling.

Republican officials, businesses, religious groups, and other groups are bringing the lawsuits from 27 states. They claim Congress did not authorize the mandate, that it is unnecessary and exceeds the legal authority of the administration.

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