By Zachary Stieber
A group seeking all the documents analyzed by U.S. drug regulators before approving Pfizer’s COVID-19 vaccine has reached an agreement with the government on how fast the documents will be produced.
The Food and Drug Administration (FDA) must produce 10,000 pages by March 1 and another 10,000 pages by April 1 in response to the Freedom of Information Act request and subsequent lawsuit by the Public Health and Medical Professionals for Transparency, according to the agreement, which was approved by the judge overseeing the case on Feb. 2.
The FDA must then produce 80,000 additional pages in three tranches, one due May 2, one due June 1, and one due July 1.
The regulatory agency was ordered to produce 70,000 pages by Aug. 1 and then 55,000 pages on or before the first business of each month thereafter.
The amendment to the production requirement keeps the total schedule at about 8 months.
The case was brought by the doctor’s group after the FDA resisted handing over the documents, which analyze Pfizer’s clinical trial evaluating the safety and efficacy of its shot and other data.
Both sides agree the group is entitled to the approximately 450,000 documents, but the FDA had pushed for a production schedule that, if approved, would have taken some 75 years to complete.
In a hearing on Dec. 14, 2021, U.S. District Judge Mark Pittman, the Trump nominee overseeing the case, described it as involving “the most important issue of our time.”
“When you’re being asked or, indeed, mandated to take something and insert a foreign substance in your body, I would think, first and foremost, that the government ought to have to—in our system of government, we’re not in communist Russia or China or in Nazi Germany—when the government has mandated something, I would think the American people are entitled to know the underlying efficacy of what they’re being asked to do. It’s no doubt in my mind that this is something that needs to be produced posthaste. The only question I have in my mind is when and how it can be done in a manner in which I’m not shutting down the entire FDA,” he said.
A Department of Justice lawyer said that the FDA had “bent over backwards” to get the plaintiffs the information they wanted but warned against ordering too much production too soon because of the labor the government insists is required.
The lawyer pointed to a set of 3,000 documents that the FDA sent to the group and said FDA employees found dozens of instances of potentially identifying information that needed redacting, highlighting why officials want to review the documents “line by line.”
Aaron Siri, a lawyer representing the plaintiffs, told the judge that the FDA could hire independent contractors, get reviewers allocated from other agencies like the DOJ, or make Pfizer review the documents. The government lawyer suggested only FDA workers can do the review. Siri also noted that the government reviewed Pfizer’s request for emergency authorization for the jab in 108 days, and that 108 days had already passed since the time of the request for documents.
At one point, Siri told the judge that making the documents public would “give confidence to the American people that the medical product that they’re being mandated to receive, the medical product that the federal government has said is the only thing that will be able to end this pandemic has, in fact, been properly reviewed, licensed and approved.”
Pittman has not ruled on Pfizer’s move to intervene in the case, though that decision should be coming shortly.