FDA Withholding COVID-19 Vaccine Safety Data is Illegal: Lawmakers Challenge FDA Commissioner Califf
FDA Withholding COVID-19 Vaccine Safety Data is Illegal: Lawmakers
By: Zachary Stieber
October 1, 2022: Rep. Gregory Steube (R-Fla.) and other U.S. lawmakers are asserting that the Food and Drug Administration’s (FDA) refusal to provide records to The Epoch Times is illegal.
The Freedom of Information Act (FOIA) states that, with exceptions, agencies that receive satisfactory records requests “shall make the records promptly available” to the requester. But the FDA recently refused to provide results of COVID-19 vaccine safety monitoring analysis to The Epoch Times, claiming that it could not separate the results from inter-agency and intra-agency communications, which are allowed to be withheld.
Steube and colleagues told FDA Commissioner Dr. Robert Califf, a Biden appointee, that they were concerned after reading the story about the refusal to provide the records, telling Califf that his agency “is obligated to disclose” the materials under FOIA.
The requested analysis was performed on reports to the Vaccine Adverse Event Reporting System (VAERS). Anybody can submit reports to VAERS, but most reports are submitted by health care workers, who are required to report adverse events following COVID-19 vaccination.
“It is unacceptable that the FDA would withhold such important material from the public eye. Americans depend on the information provided in VAERS to be able to make conscious decisions about their health and well-being,” the lawmakers told Califf in a letter dated Sept. 23. “It is critical that the FDA be transparent and release important sets of data to the public.”
They described the FDA as being “noncompliant” in releasing COVID-19 vaccine safety data, referring to how the FDA denied a request to quickly produce all the data and information for Pfizer’s vaccine. The agency later said it would take 75 years to produce the information, but a judge ordered the agency to take no longer than eight months.
The FDA did not respond to a request for comment on the letter. The agency previously declined to comment on the decision not to provide the records, citing how The Epoch Times has appealed the decision.
It’s not clear why the agency cannot comment while an appeal is pending.
The lawmakers asked the agency for answers within 30 days.
Reps. Michael Cloud (R-Texas) and Tom Tiffany (R-Wis.) also signed the letter.
After the letter was sent, the FDA denied another FOIA request related to COVID-19 vaccine safety. The agency refused to provide the results of autopsies performed on people who received COVID-19 vaccines and whose deaths were reported to VAERS. The Epoch Times has also appealed that determination.
Source: The Epoch Times
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