Judge Orders FDA To Hasten Release of Pfizer Vaccine Docs


A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months. Reuters reports: That’s roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine. The court “concludes that this FOIA request is of paramount public importance,” wrote U.S. District Judge Mark Pittman in Fort Worth, who was appointed to the bench by former President Donald Trump in 2019.

The FDA didn’t dispute it had an obligation to make the information public but argued that its short-staffed FOIA office only had the bandwidth to review and release 500 pages a month. While Pittman recognized “the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA,” in his four-page order, he resoundingly rejected the agency’s suggested schedule. Rather than producing 500 pages a month — the FDA’s proposed timeline — he ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097. “Even if the FDA may not see it this way, I think Pittman did the agency — and the country — a big favor by expediting the document production,” writes Reuters’ Jenna Greene. “Making the information public as soon as possible may help assuage the concerns of vaccine skeptics and convince them the product is safe.”

“Still, the FDA is likely to be hard-pressed to process 55,000 pages a month,” Greene adds. “The office that reviews FOIA requests has just 10 employees, according to a declaration filed with the court by Suzann Burk, who heads the FDA’s Division of Disclosure and Oversight Management. Burk said it takes eight minutes a page for a worker ‘to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request.’ […] But as lawyers for the plaintiffs Public Health and Medical Professionals for Transparency pointed out in court papers (PDF), the FDA as of 2020 had 18,062 employees. Surely some can be dispatched to pitch in at the FOIA office.”



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