Brook Jackson, the whistleblower, alleged in a suit that was unsealed in February that Pfizer and associated parties violated clinical trial regulations and federal laws, including the False Claims Act.
In its motion to dismiss, Pfizer says the regulations don’t 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 gives contract holders the ability to skirt many rules and laws that typically apply to contracts.
That means that Jackson’s claim that Pfizer must still comply with the Federal Acquisition Regulations “is simply wrong,” Pfizer said.
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.”
“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, who declined an interview request, said lawyers for Jackson are working on figuring out legal ways 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 government agreed to pay up to $1.9 billion for 100 million doses of the COVID-19 vaccine pending U.S. regulatory clearance. That included the manufacturing of the vaccine on top of researching and developing it.
The contract was granted under the “prototype” provision, which falls under the OTA. The rules for prototypes state that just one of four conditions must be satisfied. The condition that was satisfied in the Pfizer contract was the involvement of a “nontraditional defense contractor.”