Pfizer has asked a U.S. court to throw out a lawsuit brought by a whistleblower that revealed problems at the testing sites used in Pfizer's critical phase III trial of its COVID-19 vaccine.
Brook Jackson, the whistleblower, filed a False Claims Act lawsuit against Pfizer, Ventavia, and ICON, alleging they had "concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents."
But Pfizer, in its motion to dismiss the case, argued that such regulations don't apply to its vaccine contract with the U.S. Department of Defense because the agreement was conducted under the auspices of an Other Transaction Agreement (OTA), reported The Epoch Times' Zachary Stieber. An OTA allows contractors to circumvent otherwise existing rules and laws that typically apply to contracts. Pfizer was granted its contract to develop a "prototype," which falls under the protection of an OTA.
Kathryn Ardizzone, who serves as counsel with Knowledge Ecology International, said the government made up "an absurd fiction" and used an OTA to grant the contract.
Ardizzone noted that because the agreements shield contract holders from some regulations and laws, "the increasing use of OTAs, which includes contexts where it's inappropriate to do so, is undermining the rule of law and jeopardizing the public's interests." The Pfizer contract is an example of this inappropriate context, because it "was not about producing a prototype."
Pfizer argued that Jackson's claim that it was required to comply with Federal Acquisition Regulations (FAR) "is simply wrong," due to the protections listed in the OTA.
But Warner Mendenhall, the lawyer in charge of Jackson's case, said that Pfizer has "clearly not followed federal procurement laws.
"And now they're saying, 'Of course we didn't follow federal procurement laws. We didn't have to. This was just for a prototype.'"
Mendenhall added that Jackson's lawyers are currently looking to counter Pfizer's argument.
"We may lose on this issue because their contract imposes … none of the normal checks and balances on quality control and consumer protection that we fought for decades in this country," he said.
The contract in question, which was signed in the summer of 2020, outlined a base agreement and a statement of work.
Since then, the government agreed to pay $1.9 billion for 100 million doses of the COVID-19 vaccine pending U.S. regulatory approval.
"The agreement," Pfizer said, "makes no mention of the FDA regulations and FAR provisions cited in relator's complaint. The agreement instead conditions payment, more simply, on Pfizer's delivery of an FDA authorized or approved product. Pfizer's vaccine has satisfied that condition since December 2020, as the complaint acknowledges, and the vaccine continues to satisfy that condition today. The Court should reject Relator's express certification claim for this reason alone."
Commenting on the delay of Pfizer releasing the raw data from its vaccine trial, the British Medical Journal wrote, "Pharmaceutical companies are reaping vast profits without adequate independent scrutiny of their scientific claims. The purpose of regulators is not to dance to the tune of rich global corporations and enrich them further; it is to protect the health of their populations. We need complete data transparency for all studies,
we need it in the public interest, and we need it now."
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