Pfizer has asked a US court to dismiss a lawsuit filed by a whistleblower who revealed problems at sites where Pfizer’s COVID-19 vaccine was tested.

The whistleblower Brook Jackson a former clinical trial overseer for a contractor conducting trials of Pfizer’s Covid-19 vaccine claimed in February that Pfizer and associated parties violated clinical trial regulations and federal laws including the False Claims Act.

Despite the US government’s refusal to side with her Jackson is pressing ahead with a lawsuit against Pfizer and her former company Ventavia Research Group (the contractor) which fired her in 2020.

Jackson sued Pfizer Ventavia and another company involved in the trial ICON under the False Claims Act. It has been under seal for over a year after the United States Department of Justice declined to intervene on her behalf.

Pfizer claims in its motion to dismiss that the regulations do not apply to its vaccine contract with the U.S. Department of Defense because the agreement was executed under the department’s Other Transaction Authority (OTA) which allows contract holders to avoid many rules and laws that generally apply to contracts.
That means Jackson’s claim that Pfizer must still follow the Federal Acquisition Regulations is “simply wrong” according to Pfizer.
The decision not to intervene was not explained by government lawyers and the Food and Drug Administration (FDA) which investigates alleged clinical trial fraud did not respond to a request for comment.
Jackson said that the odds of success aren’t good but “it’s just a chance I have to take. I just feel like somebody has to be held accountable.”
“Warner Mendenhall a lawyer who is working on Jackson’s case said in a recent interview that Pfizer has “clearly not followed federal procurement laws.” [1]

“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 ’” he added.”
Mendenhall stated that Jackson’s lawyers are working on legal strategies 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 protectionthat we fought for decades in this country ” he said.

The contract at issue was outlined in a base agreement[2]and a statement of work[3]for the agreement both of which were signed in the summer of 2020.

The government agreed to pay up to $1.9 billion for 100 million doses of the COVID-19 vaccine subject to regulatory approval in the United States. This included manufacturing the vaccine in addition to researching and developing it.

The contract was awarded under the “prototype” provision of the OTA. The prototype rules state that only one of four conditions must be met. The inclusion of a “nontraditional defense contractor” was a condition of the Pfizer contract.

“Federal law defines nontraditional defense contractors as ‘an entity that is not currently performing and has not performed a contract or subcontract for the Department of Defense for at least one year preceding the solicitation of the OTA agreement. Pfizer has dozens of contracts with the military.That means the government certified ‘an absurd fiction’ to use an OTA to grant the contract Kathryn Ardizzone counsel with Knowledge Ecology International told The Epoch Times in an email.”

Over time the Department of Defense and other government agencies have increased their use of the OTA. According to the Government Accountability Office 34 such agreements were reached in the fiscal year 2016; by the fiscal year 2018 the number had risen to 173.[4]
Because the agreements shield contract holders from certain regulations and laws Ardizzone claims that “the increasing use of OTAs including in 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 an inappropriate context she claims because it “was not about producing a prototype.”

Pfizer’s argument that the Federal Acquisition Regulations (FAR) do not apply to the agreement is not convincing.

The basic agreement only mentions the regulations for handling classified information. The work statement makes no mention of any.

“I’m not sure what it means when an OTA is silent on a FAR regulation ” Ardizzone said. “That would be up to the judge to decide and it could rule in favor of Pfizer because the prevailing view is that FAR regulations do not always apply to an OTA.”

Pfizer noted in its motion to dismiss that the government did not join Jackson’s suit (it was filed on the government’s behalf) nor have regulators revoked the clearance of its vaccine which was authorized by the Food and Drug Administration (FDA) in late 2020 after Jackson revealed issues at Ventavia Research Group a Pfizer subcontractor.

[1]https://www.zerohedge.com/covid-19/pfizer-moves-dismiss-lawsuit-covid-19-vaccine-trial-citing-prototype-agreement
[2]https://www.documentcloud.org/documents/22028603-pfizer-base-agreement
[3]https://www.documentcloud.org/documents/22028602-pfizer-contract-statement-of-work
[4]https://www.gao.gov/assets/gao-20-84.pdf

Leave a Reply