The FDA argued in the joint report that the plaintiff's request involves more than 329,000 pages and that reviewing and redacting these records will be a time-consuming process. On this basis alone, basic liberty and government transparency demand that the documents and data submitted by Pfizer to license this product be made available to Plaintiff and the public forthwith, precisely as contemplated by federal regulations. There are few whose livelihood, education, service, and participation in civil society are not contingent on a government requirement to receive this product. For example, the White House’s recent Covid-19 Action Plan and executive orders have made receipt of this product a condition of employment for more than 6 million federal workers and contractors, 22 million healthcare professionals, 84 million private sector employees, and the enlisted and reserve members of our armed forces. The ability of a majority of Americans to participate in civil society, and even exercise basic liberty rights, are now contingent on receiving this product. The plaintiff went on to argue that the release of these documents is of the utmost importance as the "ability of a majority of Americans to participate in civil society, and even exercise basic liberty rights, are now contingent on receiving this product." The FDA now has an equally important task of making those documents available to the Plaintiff in this case and the public at large in at least the same timeframe. We assume, as the FDA has stated, that it conducted an intense, robust, thorough and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021,14 to when the product was licensed on August 23, 2021. This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s Covid-19 vaccine (the “Pfizer vaccine”). Plaintiff seeks the records submitted to the FDA by Pfizer to license its COVID-19 vaccine (the “FOIA request”) and requests an order requiring the FDA to produce all documents responsive to its FOIA request no later than March 3, 2022. The plaintiff chose this date as it gives the FDA 108 days, the same amount of time it took the agency to review the data to license Pfizer's COVID-19 vaccine. The Public Health and Medical Professionals for Transparency (plaintiff) argued that the FDA should release these documents no later than March 3, 2022. District Court for the Northern District of Texas and are now waiting for the court to decide on a schedule for the release of these documents. On November 15, 2021, the FDA and Public Health and Medical Professionals for Transparency presented a joint report to the U.S. The agency’s FOIA Requester Service Center is available to assist you with any question about the status of your request and any steps you can take to receive a quicker response. Complex requests typically seek a high volume of material or require additional steps to process such as the need to search for records in multiple locations. Simple requests are typically more targeted and seek fewer pages of records. A simple request can be processed faster by the agency than one that is complex. The time it takes to respond to a request will vary depending on the complexity of the request and any backlog of requests already pending at the agency. Department of Justice wrote:Īgencies typically process requests in the order of receipt. While the government is required to respond to these requests, the amount of time it takes to fulfill these requests varies depending on the number of documents requested, the backlog at the responding agency, and the complexity of the involved documents. This claim stems from an FOIA request filed by Public Health and Medical Professionals for Transparency for the data the FDA relied upon to license Pfizer's COVID-19 vaccine. While the FDA argues that this is a rather standard processing schedule, if adhered to it would take the FDA more than 50 years, or until 2076, to completely fulfill. The FDA responded to a Freedom of Information Act (FOIA) request for more than 300,000 pages of data related to the licensure of Pfizer's COVID-19 vaccine by proposing a processing schedule that would see the release of 500 pages every month. The FDA did not request a delay in the release of its COVID-19 data until 2076.
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