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 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.
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