The FDA said it spent more than $3.5 million to produce over 1 million Pfizer documents, and that it has met its obligation under the Freedom of Information Act. However, critics accused the FDA of withholding key information.
The U.S. Food and Drug Administration (FDA) last week asked a Texas court to shut down a lawsuit seeking documents related to the FDA’s licensing of Pfizer’s Comirnaty COVID-19 vaccine for ages 16 and up.
Public Health and Medical Professionals for Transparency (PHMPT) — a group of more than 30 medical and public health professionals and scientists from Harvard, Yale, UCLA and other institutions — sued the FDA in Sept 2021, after the agency failed to respond to a Freedom of Information Act (FOIA) request for “all data and information for the Pfizer Vaccine,” including safety and effectiveness data, adverse reaction reports, and a list of active and inactive ingredients.
The case is being heard in the U.S. District Court for the Northern District of Texas.
On Oct. 17, the FDA filed a motion to throw out the lawsuit, arguing that the agency had “complied with its obligations under FOIA” by conducting a “good faith search that was reasonably calculated to uncover all responsive records.”
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