The regulators have not revoked approval of Pfizer’s vaccine, which was approved by the FDA in late 2020, even after Brook Jackson disclosed problems at sites managed by Ventavia Research Group. Now, Pfizer is asking to dismiss the lawsuit revealing problems at COVID-19 vaccine trial sites entirely.
Pfizer has requested a US court to dismiss a case filed by a whistleblower who exposed flaws at Pfizer’s COVID-19 vaccine testing facility.
In a lawsuit disclosed in February, whistleblower Brook Jackson claimed that Pfizer and related parties breached clinical trial standards and federal statutes, including the False Claims Act.
Pfizer argued in its movement to dismiss that the regulations do not pertain to its vaccine deal with the US Department of Defense because it was signed under the department’s Other Transaction Authority (OTA), which allows contract holders to avoid many of the rules and regulations that normally apply to contracts.
According to Pfizer, Jackson’s assertion that Pfizer should still adhere with the Federal Acquisition Regulation “is simply wrong.”
Pfizer has “clearly not followed federal procurement laws,” according to Warner Mendenhall, an attorney who is consulting on Jackson’s lawsuit.
“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 said.
Jackson’s lawyers are focusing on legal strategies to dispute Pfizer’s position, according to Mendenhall.
“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.
A base agreement (read below) and a statement of work for the agreement were signed in the summer of 2020, and the contract in question was described in those documents.
In exchange for 100 million doses of the COVID-19 vaccine, the government decided to pay up to $1.9 billion, subject to US regulatory approval. This involves not just studying and developing the vaccine, but also manufacturing it.
The contract was awarded in accordance with the OTA’s “prototype” rule. The prototype regulations say that only one of four conditions must be met. The inclusion of a “nontraditional defense contractor” was a condition of the Pfizer deal that was met.
Nontraditional defense contractors are defined by federal law as “an entity that is not currently performing and has not performed” a contract or subcontract with the Department of Defense for at least one year prior to the OTA agreement request. The military has numerous of deals with Pfizer.
Kathryn Ardizzone, counsel with Knowledge Ecology International, explained that the government approved “an absurd fiction” to utilize an OTA to award the contract.
Over time, the OTA has become more widely used by the Department of Defense and other federal organizations. According to the Government Accountability Office (pdf), 34 such agreements were reached in fiscal year 2016; by fiscal year 2018, the number had risen to 173.
According to Ardizzone, “the increasing use of OTAs, which includes in contexts where it’s inappropriate to do so, is undermining the rule of law and jeopardizing the public’s interests” because the contracts insulate agreement owners from certain laws and regulations. Since the deal “was not about producing a prototype,” she argued, the Pfizer deal is an example of an improper setting.
It is unclear whether Pfizer’s claim that the FAR does not pertain to the agreement is correct.
Only the rules for handling classified information are mentioned in the base agreement. No such thing is mentioned in the statement of work.
“I’m not sure what it means when an OTA is silent on a regulation that appears in the FAR,” Ardizzone said. “That would be up for the judge to decide, and it might side with Pfizer since the prevailing view is that FAR regulations do not necessarily apply for an OTA.”
Pfizer contended in its motion to dismiss that the government did not join Jackson’s lawsuit—it was filed on the government’s behalf—and that regulators have not revoked approval of its vaccine, which was approved by the Food and Drug Administration (FDA) in late 2020 after Jackson disclosed problems at sites managed by Ventavia Research Group, a Pfizer subcontractor.
“The agreement makes no mention of the FDA regulations and FAR provisions cited in relator’s complaint,” the motion reads. “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.”
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