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. However, the FDA
recently refused to provide the results of COVID-19 vaccine safety monitoring analysis to The Epoch Times, claiming that it couldn’t 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 about the FDA’s 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 vaccinations.
“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 agency denied a request to quickly produce all the data and information for Pfizer’s vaccine. The agency later
stated that it would take 75 years to produce the information, but a judge
ordered the agency to take no longer than eight months.
The FDA didn’t respond to a request for comment on the letter. The agency previously declined to comment on the decision to not provide the records, citing that The Epoch Times has appealed the decision.
It isn’t clear why the agency can’t 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.
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