FDA asks Texas court to shut down 19 vaccine records lawsuit

Reuters

FDA asks Texas court to shut down 19 vaccine records lawsuit

2024 10월 18, 오후 5:49 GMT

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Adds comment from FDA, plaintiff in paragraphs 7-9

By Mike Scarcella

Oct 18 (Reuters) -The U.S. Food and Drug Administration has asked a federal judge in Texas to throw out a public records lawsuit related to COVID-19 vaccines, arguing that it has already spent more than $3.5 million to produce more than 1 million documents in the case.

The FDA in a filing on Thursday defended the adequacy of the records it provided in the lawsuit, which was filed by scientists who wanted to see licensing information that the agency relied on to approve the Pfizer-BioNTech coronavirus vaccine.

The lawsuit, filed in late 2021, attracted widespread attention after the FDA said early on that it could take decades to process and disclose records to Public Health and Medical Professionals for Transparency, the group that brought the case.

The public records lawsuit said that “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 Vaccine.”

It said the requested data would help resolve questions about the FDA’s review process.

U.S. District Judge Mark Pittman in an order in early 2022 set an accelerated time frame for the FDA, calling the group's Freedom of Information Act request an issue “of paramount public importance.”

The FDA declined to comment.

Aaron Siri, a lawyer for Public Health and Medical Professionals for Transparency, in a statement on Friday said the fight for records was not over.

“Despite years of litigation, and the Court’s order to produce all clinical trial documents, FDA continues to improperly withhold over a million pages of trial documents," Siri said.

The agency at one point was producing 55,000 pages of records every 30 days in response to court orders in the lawsuit. It said in Thursday's filing seeking to close the case that it set up “unprecedented and extraordinary operations” to comply with Pittman’s directives.

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.

Lawyers for the group said in a recent court filing that they would waive any further challenge to redactions that the FDA made in the more than 1.2 million documents released as part of the lawsuit.

The adequacy of the FDA’s search for records is the remaining contested issue in the lawsuit.

The FDA said it conducted a “reasonable and adequate search for responsive records.” The group is due to respond to the FDA by Nov. 7.

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 ElizabethBrehm of Siri & Glimstad

For defendant: Andrew Freidah of the U.S. Justice Department

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Reporting by Mike Scarcella

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