Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA

3 minute read

A vial and a syringe are seen in front of a displayed Pfizer logo in this illustration taken November 27, 2021. REUTERS/Dado Ruvic

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  • Drug company wants to protect any trade secrets, business proprietary information
  • Plaintiffs contend Pfizer's bid in Texas federal court is untimely

(Reuters) - Pfizer Inc wants to intervene in a Texas federal lawsuit seeking information from the U.S. Food and Drug Administration used in licensing the company's COVID-19 vaccine, a litigation move that plaintiffs who are suing for the data say is premature.

Pfizer's lawyers at DLA Piper told U.S. District Judge Mark Pittman on Jan. 21 it wanted a role in the proceedings to help the FDA avoid "inappropriately" disclosing trade secret and confidential commercial information.

On Tuesday night, the group of doctors and scientists who sued last year over public access to the FDA's Pfizer licensing records said in a court filing that the company's bid to jump into the lawsuit was untimely because the plaintiffs have not challenged any redactions to requested records.

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Earlier this month, the judge ordered a fast-track release of hundreds of thousands of documents, calling the case "of paramount public importance."

U.S. government agencies control the release of information under federal public-records laws, but companies can challenge and even sue to block the disclosure of certain details.

The FDA said on Tuesday in its court filing that it welcomed the opportunity to coordinate with Pfizer amid what the agency called the "unusual and indeed extraordinary circumstances" of the case.

Pittman scheduled a hearing for Friday to consider Pfizer's bid to intervene. The judge is also expected to take up the FDA's logistical concerns about his Jan. 6 order that directed the agency to release 55,000 pages monthly starting on March 1.

The FDA declined to comment on Wednesday, and Pfizer said in a statement that its intervention "will help accelerate the release of documents."

The FDA earlier drew criticism over its plan to release 500 pages a month in response to the lawsuit from Public Health and Medical Professionals for Transparency, a production schedule that would take more than 50 years to complete. Siri & Glimstad, the New York boutique firm that filed the lawsuit, has fought mandatory vaccination efforts.

In its filing, Pfizer said the company supports public disclosure of FDA records "to promote transparency and the public's confidence in the vaccine."

The company's filing said it was not aware of the lawsuit before reading news media reports about it.

The plaintiffs said in their filing that Pfizer could help the FDA without intervening in the lawsuit. The attorneys also said they would not oppose Pfizer's intervention if the company's "involvement is limited to prevent delay or prejudice."

The case is Public Health and Medical Professionals for Transparency v. Food and Drug Administration, U.S. District Court for the Northern District of Texas, No. 4:21-cv-01058.

For plaintiff: Aaron Siri of Siri & Glimstad; and John Howie of Howie Law

For FDA: Courtney Enlow of the U.S. Justice Department

Read more:

'Paramount importance': Judge orders FDA to hasten release of Pfizer vaccine docs

Wait what? FDA wants 55 years to process FOIA request over vaccine data

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