Texas judge orders FDA to release massive batches of Pfizer Inc.’s vaccine data every month.
QUICK FACTS:
- A United States District Court for the northern district of Texas, Fort Worth division has ordered the Food and Drug Administration (FDA) to release hundreds of thousands of pages of Pfizer’s licensing data for its COVID-19 gene therapy drug, rejecting the FDA’s request to release only 500 pages per month, a process that would have taken more than 50 years to complete.
- The FDA must release 10,000 pages per month for the first two months.
- The original lawsuit against the FDA was filed by Public Health and Medical Professionals for Transparency, a nonprofit whose aim is “to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines,” according to its website.
- The court is requiring FDA to roll out the batches of data “on the first business day of each month, instead of once every thirty days,” according to the order.
- The court order was signed by U.S. District Judge Mark T. Pittman.
READ THE COURT ORDER:
056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULEDownload
WHAT ELSE THE COURT ORDERED:
- The Texas court also ordered the FDA to produce “10,000 pages for the first two productions, which will be due on or before March 1 and April 1, 2022.”
- Moreover, the FDA will produce “80,000 pages on or before May 2, June 1, and July 1, 2022; 70,000 pages on or before August 1, 2022; and then 55,000 pages on or before the first business day of each month thereafter.”
- The order also says the FDA can “bank” excess pages of its monthly quota, “such that, for example, if the FDA produces 90,000 pages in May 2022 (or 65,000 pages in September 2022), it would bank 10,000 pages. Then, in a subsequent month, if the FDA is unable to produce the full amount of pages required, it can apply the banked pages toward its quota for that month.”
BACKGROUND:
- Pfizer had tried to block Public Health and Medical Professionals for Transparency’s FOIA request for the pharmaceutical company’s vaccine safety data to be released immediately.
- Pfizer “asked a federal court to let it intervene in a high-profile case that has seen U.S. drug regulators try to slow-walk disclosure of data on Pfizer’s COVID-19 vaccine,” The Epoch Times reported last month.
- Pfizer said it wanted to ensure that certain safety data information was “exempt from disclosure” to the public, asking a U.S. judge for 75 years to release their safety data. But the judge rejected Pfizer’s request, ordering the FDA to produce 55,000 pages a month, allowing about eight months to fully disclose the records, reports Epoch Times.
