Judge orders FDA to produce Pfizer safety data in eight months

pharmafile | January 7, 2022 | News story | Medical Communications  

A federal judge has ordered the FDA to make public tens of thousands of more pages on the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a significantly accelerated schedule which could result in the release of all information within approximately eight months.

The FDA cited staffing issues in December, and agreed to release 12,000 pages by the end of January, and a minimum of 500 pages a month going forward, according to a report from Reuters. The number was found to be unacceptable by Public Health and Medical Professionals, who said that there are over 450,000 more pages of material about the vaccine needed, under a Freedom of Information Act (FOIA) request.

The FDA shared that its short-staffed FOIA office only had the resources to release 500 pages a month, though it did not dispute its obligation to make the information public. District Judge Mark Pittman recognized “the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA”, in his order. However, the order makes clear that “this FOIA request is of paramount public importance”, and rejects the FDA’s suggested schedule.

The schedule outlined instead will see the 12,000 pages suggested by the FDA’s proposed schedule, alongside “the remaining documents at the rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.” This contrasts with the FDA’s original estimation of all Pfizer vaccine data being public by the year 2097.

The office reviewing FOIA requests for the FDA has only 10 employees, according to a declaration filed with the court by Suzann Burk, who heads the FDA’s Division of Disclosure and Oversight Management. At the rate of the request, the 10 employees would have to work constantly for 24 hours a day, seven days a week, even to produce a figure short of the 55,000 monthly pages outlined, reported Reuters.

Ana Ovey

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