![]() However, this has not stopped anti-vaccine advocates from using the released documents to question the safety of Covid-19 vaccines, MedPage Today reports. Before the documents can be released, the agency must redact confidential business and trade secret information from Pfizer and BioNTech, as well as private patient information from clinical trials.Īlthough the court noted that releasing this many documents this quickly would have "unduly burdensome challenges" for FDA, it said releasing the documents is of "paramount public important" and expediting the process is "not only practicable, but necessary."Īccording to Zach Zalewski, a regulatory strategy consultant at Avalere Health, the released documents will "literally include every scrap of paper that was submitted to FDA for the entirety of the pandemic," but they are not likely to be useful in determining the vaccine's overall safety and efficacy. Under the court order, FDA was required to release approximately 12,000 pages of documents immediately, and then 55,000 pages a month until all documents-totaling more than 300,000 pages-are released. District Judge Mark Pittman of the Northern District of Texas in January issued a court order requiring FDA to significantly speed up the release of the documents. FDA said the agency branch responsible for handling the request has only 10 employees and is currently processing 400 other FOIA requests, MedPage Today reports. In response to the lawsuit, FDA in November proposed releasing around 500 pages of the review documents each month-which would fulfill the organization's FOIA request in around 55 to 75 years. ![]() In September, Public Health and Medical Professionals for Transparency sued FDA, claiming the agency denied a request to expedite the release of Pfizer-BioNTech's Covid-19 vaccine review documents via the Freedom of Information Act (FOIA). Your top resources on the Covid-19 vaccines Lawsuit expedites FDA's release of vaccine data Surely some can be dispatched to pitch in at the FOIA office.FDA last week released 55,000 pages of review documents for Pfizer-BioNTech's Covid-19 vaccine, which some experts say may lead to "cherry picking and taking things out of context" when it comes to vaccine efficacy and safety. Burk said it takes eight minutes a page for a worker 'to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request.' But as lawyers for the plaintiffs Public Health and Medical Professionals for Transparency pointed out in court papers (PDF), the FDA as of 2020 had 18,062 employees. 'The office that reviews FOIA requests has just 10 employees, according to a declaration filed with the court by Suzann Burk, who heads the FDA's Division of Disclosure and Oversight Management. 'Still, the FDA is likely to be hard-pressed to process 55,000 pages a month,' Greene adds. 'Making the information public as soon as possible may help assuage the concerns of vaccine skeptics and convince them the product is safe.' 'Even if the FDA may not see it this way, I think Pittman did the agency - and the country - a big favor by expediting the document production,' writes Reuters' Jenna Greene. That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097. Rather than producing 500 pages a month - the FDA's proposed timeline - he ordered the agency to turn over 55,000 a month. ![]() While Pittman recognized 'the 'unduly burdensome' challenges that this FOIA request may present to the FDA,' in his four-page order, he resoundingly rejected the agency's suggested schedule. The FDA didn't dispute it had an obligation to make the information public but argued that its short-staffed FOIA office only had the bandwidth to review and release 500 pages a month. District Judge Mark Pittman in Fort Worth, who was appointed to the bench by former President Donald Trump in 2019. ![]() The court 'concludes that this FOIA request is of paramount public importance,' wrote U.S. Reuters reports: That's roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine. A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer's COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |