FDA Misled The Judiciary About Pfizer's Vaccine Documents

On December 6, 2024, a federal judge ordered the US Food and Drug Administration (FDA) to release documents related to the emergency use authorisation of Pfizer’s Covid-19 vaccine. These documents had been hidden from public view.

The legal battle traces back to September 2021, when attorney Aaron Siri filed a lawsuit under the Freedom of Information Act (FOIA) on behalf of the Public Health and Medical Professionals for Transparency. The plaintiffs sought access to the vast trove of documents the FDA relied on to approve Pfizer’s vaccine.

Initially, the FDA proposed a slow release schedule. In November 2021, the agency stated it would release just 500 pages per month—a pace that would have stretched the full disclosure process to 75 years.

However, in January 2022, District Judge Mark Pittman of Texas rejected the FDA’s proposal, ordering the agency to expedite its release to 55,000 pages per month, aiming to complete the disclosure of all 450,000 pages by August 2022.

As the documents trickled out, researchers began uncovering glaring gaps that prevented a systematic review of the data. These gaps fueled suspicions about what else the FDA might be withholding.

It became evident that the FDA had withheld records directly tied to its emergency use authorisation of Pfizer’s vaccine, estimated to be over one million pages.

These documents, which the FDA had full knowledge of, were excluded from earlier disclosures, effectively misleading the judiciary and undermining public trust.

Siri didn’t mince words.

“The FDA has been hiding a million pages from the Court, the plaintiff, and the public. Only those concerned about the truth seek to conceal evidence,” said Siri in an interview.

“The FDA here is clearly concerned about the truth and lacks confidence in the review that it conducted to license Pfizer’s COVID-19 vaccine because it is doing everything possible to prevent independent scientists from conducting an independent review,” he added.

https://brownstone.org/articles/fda-misled-the-judiciary-about-pfizers-vaccine-documents/

Judge orders Trump administration to restore funds for foreign aid programs

A U.S. district judge said the administration failed to account for the extraordinary harm caused by the broad-based halt.

A federal judge on Thursday ordered the Trump administration to restore funding for hundreds of foreign aid contractors who say they’ve been devastated by President Donald Trump’s abrupt — and in their view illegal — 90-day blanket freeze.

U.S. District Judge Amir Ali, a Washington, D.C.-based appointee of President Joe Biden, said the Trump administration failed to account for the extraordinary harm caused by the broad-based halt to foreign aid.

“At least to date, Defendants have not offered any explanation for why a blanket suspension of all congressionally appropriated foreign aid, which set off a shock wave and upended reliance interests for thousands of agreements with businesses, nonprofits, and organizations around the country, was a rational precursor to reviewing programs,” Ali wrote.

“Absent temporary injunctive relief, therefore, the scale of the enormous harm that has already occurred will almost certainly increase,” the judge added.

Ali barred Trump’s top State Department and budget aides — including Secretary of State Marco Rubio and Office of Management and Budget Director Russell Vought — from implementing any contract cancellations or stop-work orders put into effect after Trump’s inauguration, at least while further litigation plays out.

The ruling effectively halts a central component of one of Trump’s Day One executive orders commanding his administration to freeze foreign aid for 90 days.

The judge concluded that the Trump administration appeared to act in an “arbitrary and capricious” manner by abruptly shutting off all foreign aid without considering consequences for businesses to whom that aid was awarded prior to Trump’s inauguration.

“There is nothing arbitrary and capricious about executive agencies conducting a review of programs,” he said. “But there has been no explanation offered … as to why reviewing programs — many longstanding and taking place pursuant to contractual terms — required an immediate and wholesale suspension of appropriated foreign aid.”

Lawyers for the contractors described extensive damage and disruption caused by Trump’s bid to freeze and cancel thousands of ongoing contracts with organizations funded by USAID foreign assistance dollars. Their claims were bolstered by a list the administration delivered at the judge’s order of more than 200 foreign aid contracts that were canceled just this week.

“Businesses are shuttering, terminating employees … food is rotting, medication is expiring,” attorney Stephen Wirth described in a 90-minute, conference-call hearing Ali held Wednesday as the courthouse was closed due to snow.

Lawyers for the contract and grant recipients emphasized that it wasn’t just foreign organizations being harmed but businesses and organizations across the United States — who work with overseas partners — that were laying off or furloughing nearly their entire staffs. Many of them won’t survive the 90-day freeze, the attorneys said.

“Shutting down billions of dollars in government spending, sending numerous foreign aid partners large and small into oblivion, shutting them down so they are out of business is clearly of sufficient political, social and economic significance that it would require clear congressional authorization,” another attorney for the groups argued.

Ali agreed that the harm being caused by the freeze, coupled with their credible arguments that the freeze could violate laws against government officials making “arbitrary and capricious” decisions, justified ordering the administration to lift the freeze while further litigation plays out.

In the arguments Wednesday, the Justice Department took an unusually expansive view of executive power. DOJ attorney Eric Hamilton argued that, because the steps being taken are at presidential direction, the groups had no authority to challenge the actions by USAID and the State Department under the Administrative Procedure Act, which is what allows courts to block “arbitrary and capricious” actions by federal agencies.

https://www.politico.com/news/2025/02/13/foreign-aid-funding-trump-administration-00204289