Dec 6 (Reuters) - A federal judge has ordered the U.S.
Food and Drug Administration to publicly disclose more
information underpinning its authorization of COVID-19 vaccines,
after failing to persuade the court to end the public records
lawsuit.
In a ruling on Friday, U.S. District Judge Mark Pittman in
Fort Worth, Texas, ordered the agency to produce its "emergency
use authorization" file to a group of scientists who wanted to
see licensing information that the FDA relied on to approve the
Pfizer-BioNTech coronavirus vaccine.
"The COVID-19 pandemic is long passed and so has any
legitimate reason for concealing from the American people the
information relied upon by the government in approving the
Pfizer ( PFE ) vaccine," wrote Pittman, appointed in 2019 by
then-President Donald Trump.
The lawsuit, filed in late 2021, attracted attention after
the FDA said it could take decades to process and disclose
records to Public Health and Medical Professionals for
Transparency, the group that brought the case.
The FDA declined to comment.
Attorney Aaron Siri, representing the Public Health and
Medical Professionals for Transparency, welcomed Pittman's
order.
"The FDA clearly lacks confidence in the review that it
conducted to license Pfizer's ( PFE ) COVID-19 vaccine because it is
doing everything possible to prevent independent scientists from
conducting an independent review," Siri said.
He said the agency was "hiding from the court and the
plaintiff one million pages of clinical trial documents from the
COVID-19 vaccine clinical trials."
The FDA has power to grant "emergency use authorization" for
vaccines and some other medical products.
The lawsuit said, "the medical and scientific community and
the public have a substantial interest in reviewing the data and
information underlying the FDA's approval of the Pfizer ( PFE )
vaccine."
The agency has countered that its "emergency use
authorization" file did not fall within the scientist group's
records request.
The FDA said in a filing that it has produced more than 1
million pages of records in the lawsuit. The filing also said
that it had set up "unprecedented and extraordinary operations"
- spending more than $3.5 million - to comply with Pittman's
directives to speed up the search and delivery of responsive
records.
Public Health and Medical Professionals for Transparency,
whose members include professors and scientists from Yale,
Harvard, UCLA and Brown, has posted thousands of records on its
website.
The case is Public Health and Medical Professionals for
Transparency v. U.S. Food and Drug Administration, U.S. District
Court for the Northern District of Texas, No. 4:21-cv-01058-P.
For plaintiff: Aaron Siri and Elizabeth Brehm of Siri &
Glimstad
For defendant: Andrew Freidah of the U.S. Justice Department
Read more:
FDA asks Texas court to shut down COVID-19 vaccine records
lawsuit
'Paramount importance': Judge orders FDA to hasten release
of Pfizer ( PFE ) vaccine docs
Wait what? FDA wants 55 years to process FOIA request over
vaccine data