![]() In its final brief to the Court, the FDA admitted that the total page count was at least 451,000, but still sought permission to produce just 500 pages per month. The agency originally estimated it would need to produce 329,000 pages, and asked the court for permission to produce just 500 pages per month, which would have taken 55 years. Therefore, in September 2021, the scientists, represented by their attorneys at Siri & Glimstad, sued the FDA demanding it produce this data by March 2022. The scientists explained that, until all the data is produced, a proper review cannot be conducted because missing even a single data set could throw off any analysis. With that promise in mind, after the vaccine’s licensure in August 2020, Public Health and Medical Professionals for Transparency, a group of highly credentialed scientists submitted a FOIA request to the FDA for the data submitted by Pfizer. In its attempts to build public support for Covid-19 vaccinations, the FDA repeatedly promised “ full transparency,” and reaffirmed its “ commitment to transparency” when licensing Pfizer’s Covid-19 vaccine. The FDA wanted court approval to have up to 75 years to publicly disclose this information. Our Standards: The Thomson Reuters Trust Principles.In response to a Freedom of Information Act request, the Food and Drug Administration asked a federal judge for permission to make the public wait until the year 2096 to disclose all of the data it relied upon to license Pfizer’s Covid-19 vaccine. Wait what? FDA wants 55 years to process FOIA request over vaccine data 'Paramount importance': Judge orders FDA to hasten release of Pfizer vaccine docs 4:21-cv-01058.įor plaintiff: Aaron Siri of Siri & Glimstad and John Howie of Howie Lawįor FDA: Courtney Enlow of the U.S. District Court for the Northern District of Texas, No. The case is Public Health and Medical Professionals for Transparency v. The attorneys also said they would not oppose Pfizer's intervention if the company's "involvement is limited to prevent delay or prejudice." The plaintiffs said in their filing that Pfizer could help the FDA without intervening in the lawsuit. The company's filing said it was not aware of the lawsuit before reading news media reports about it. In its filing, Pfizer said the company supports public disclosure of FDA records "to promote transparency and the public's confidence in the vaccine." Siri & Glimstad, the New York boutique firm that filed the lawsuit, has fought mandatory vaccination efforts. 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. The FDA declined to comment on Wednesday, and Pfizer said in a statement that its intervention "will help accelerate the release of documents." 6 order that directed the agency to release 55,000 pages monthly starting on March 1. The judge is also expected to take up the FDA's logistical concerns about his Jan. Pittman scheduled a hearing for Friday to consider Pfizer's bid to intervene. 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. 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. 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.Įarlier this month, the judge ordered a fast-track release of hundreds of thousands of documents, calling the case "of paramount public importance." 21 it wanted a role in the proceedings to help the FDA avoid "inappropriately" disclosing trade secret and confidential commercial information. 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. (Reuters) - Pfizer Inc wants to intervene in a Texas federal lawsuit seeking information from the U.S. Plaintiffs contend Pfizer's bid in Texas federal court is untimely. ![]() ![]() Drug company wants to protect any trade secrets, business proprietary information.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |