{"id":1199801,"date":"2022-01-08T13:50:43","date_gmt":"2022-01-08T18:50:43","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1199801"},"modified":"2022-01-08T13:50:52","modified_gmt":"2022-01-08T18:50:52","slug":"judge-gives-fda-8-months-to-release-pfizer-vaccine-data-after-agency-requested-75-years","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/judge-gives-fda-8-months-to-release-pfizer-vaccine-data-after-agency-requested-75-years\/","title":{"rendered":"Judge Gives FDA 8 Months to Release Pfizer Vaccine Data After Agency Requested 75 Years"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">30<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Fjudge-gives-fda-8-months-to-release-pfizer-vaccine-data-after-agency-requested-75-years%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=1199801&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><div><img decoding=\"async\" src=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-content\/uploads\/2022\/01\/Suit-640x335-1.jpg\" class=\"ff-og-image-inserted\" alt=\"image\" \/><\/div>\n<p class=\"subheading\">A federal judge on Thursday <a href=\"https:\/\/www.sirillp.com\/wp-content\/uploads\/2022\/01\/ORDER_2022_01_06-9e24e298ae561d16d68a3950ab57077b.pdf\">ordered<\/a> the U.S. Food and Drug Administration (FDA) to <a href=\"https:\/\/phmpt.org\/pfizers-documents\/\">release<\/a> Pfizer vaccine data within approximately eight months after the agency had asked for 75 years to fully comply with an extensive public records request.<\/p>\n<p>President Donald Trump appointee Judge Mark Pittman ordered the agency to produce 12,000 pages of&nbsp;Public Health and Medical Professionals for Transparency\u2019s (<a href=\"https:\/\/phmpt.org\/\">PHMPT<\/a>) request by January 31, 2022, followed by 55,000 pages every 30 days. The first round is due by March 1, 2022.<\/p>\n<figure id=\"D-ROS-B1\" class=\"a8d\"><\/figure>\n<figure id=\"M-ROS-B1\" class=\"a8d\"><\/figure>\n<figure id=\"gmxrevmore\" class=\"H\"><\/figure>\n<p>Pittman wrote in part:<\/p>\n<blockquote>\n<p><span>\u201cOpen government is fundamentally an American issue\u201d\u2014it is neither a Republican nor a Democrat issue. As James Madison wrote, \u201c[a] popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be their own Governors, must arm themselves with the power which knowledge gives.\u201d<\/span><\/p>\n<p><span>John F. Kennedy likewise recognized that \u201ca nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.\u201d And, particularly appropriate in this case, John McCain (correctly) noted that \u201c[e]xcessive administrative secrecy . . . feeds conspiracy theories and reduces the public\u2019s confidence in the government.\u201d<\/span><\/p>\n<\/blockquote>\n<p>PHMPT\u2019s attorney Aaron Siri in court filings <a href=\"https:\/\/phmpt.org\/wp-content\/uploads\/2021\/12\/031-REPLY-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-22-Brief-Memorandum-in-Support-of-Motion.pdf\">estimated<\/a> that the size of the FOIA request \u201cappears to be at least 451,000 pages,\u201d which would take roughly 75 years to complete at the FDA\u2019s <a href=\"https:\/\/phmpt.org\/wp-content\/uploads\/2021\/11\/111521-Second-Joint-Status-Report.pdf\">proposed rate<\/a> of 500 pages released per month.&nbsp;According to the court-ordered production schedule, PHMPT should receive 451,000 pages by October 1, 2022.<\/p>\n<p>Pittman concluded that while the request may be \u201cunduly burdensome,\u201d releasing the data is of \u201cparamount public importance.\u201d The FDA previously argued the request would burden its Access Litigation and Freedom of Information Branch (the \u201cBranch\u201d), which at the time had \u201ca total of ten employees, including the director and two trainees.\u201d The plaintiff, PHMPT, argued the FDA has a multi-billion dollar budget and is capable of hiring more employees as needed, or asking Congress for a bigger budget.<\/p>\n<figure id=\"M-ROS-B2\" class=\"a8d\"><\/figure>\n<p>\u201cThere may not be a \u201cmore important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not [] rush[ed] on behalf of the United States . . . . .\u201d the judge wrote, quoting from an earlier scheduling conference.<\/p>\n<p>The lawsuit <a href=\"https:\/\/www.breitbart.com\/politics\/2021\/11\/20\/fda-wants-to-wait-until-2076-to-fully-release-pfizer-coronavirus-vaccine-data\/\">stems<\/a> from a FOIA request from PHMPT, a group which is comprised of at least 30 scientists and professors from universities like Harvard, Yale, Brown, and UCLA. The group says it is a nonprofit that takes no partisan position on the data but \u201cexists solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines\u201d for the sake of transparency.<\/p>\n<p>After the FDA denied the group an expedited records request of all data pertaining to the licensing of Pfizer\u2019s vaccine,&nbsp;PHMPT&nbsp;<a class=\"x5l\" href=\"http:\/\/phmpt.org\/wp-content\/uploads\/2021\/10\/001-Complaint-101021.pdf\" target=\"_blank\" rel=\"noopener external\">filed<\/a> a lawsuit&nbsp;in September in the U.S. District Court for the Northern District of Texas. The group contends that reviewing the information will \u201csettle the ongoing public debate regarding the adequacy of the FDA\u2019s review process.\u201d T<span>he nonprofit also emphasized the urgency of the release, noting that the ability for a majority of Americans to participate in civil society, \u201cand even the exercise of basic liberty rights, are now contingent on receiving this product.\u201d<\/span><\/p>\n<p>The FDA initially replied asking Pittman to grant the agency 55 years to fully release the data due to the volume of the request,&nbsp;court documents&nbsp;<a href=\"https:\/\/www.sirillp.com\/wp-content\/uploads\/2021\/11\/020-Second-Joint-Status-Report-8989f1fed17e2d919391d8df1978006e.pdf\">show<\/a>. However, in a December 6 brief, the FDA <a href=\"https:\/\/www.sirillp.com\/wp-content\/uploads\/2021\/12\/FDA-Brief-and-Appendix-e3999de9aee38921cd4fbb035c33e304.pdf\">admitted<\/a> it had found tens of thousands more pages of data and 126 data files to add to the request, meaning the 500-page per month timeline would conclude potentially in 2096. Arguably, by then most of the members of PHMPT would no longer be alive.<\/p>\n<p>Pittman acknowledged the need for timeliness in his order, quoting court precedent to back up his reasoning.&nbsp;<span>\u201cCongress has long recognized that \u2018information is often useful only if it is timely\u2019 and that therefore, \u2018excessive delay by the agency in its response is often tantamount to denial\u2019\u201d, he wrote.<\/span><\/p>\n<figure id=\"M-ROS-B3\" class=\"a8d adSo\"><\/figure>\n<p><span>In an exclusive statement to Breitbart News on Friday, Siri said Pittman\u2019s decision is a \u201cgreat win for transparency.\u201d<\/span><\/p>\n<p><span>\u201cAmericans are mandated to receive this product and cannot sue Pfizer for harm it may cause, so we are pleased that at least the public and independent scientists will have access to the data underlying its licensure,\u201d he continued.&nbsp;<\/span><\/p>\n<p><span>Breitbart News reached out to the FDA for comment on the lawsuit and also asked whether the agency plans to hire more employees to handle the FOIA request. A spokesperson for the agency said, \u201cThe FDA cannot comment on pending, ongoing, or possible litigation.\u201d<\/span><\/p>\n<p><span>The case is&nbsp;<em>Public Health and Medical Professionals for Transparency v. Food and Drug Administration<\/em>, No. 4:21-cv-1058 in the United State District Court for the Northern District of Texas.&nbsp;<\/span><\/p>\n<p><span><em>Katherine Hamilton is a political reporter for Breitbart News. You can follow her on&nbsp;<a class=\"x5l\" href=\"https:\/\/twitter.com\/katherineeeeee2\" target=\"_blank\" rel=\"noopener external\">Twitter<\/a>.<\/em><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A federal judge on Thursday ordered the U.S. Food and Drug Administration (FDA) to release Pfizer vaccine data within approximately eight months after the agency had asked for 75 years &#8230;<\/p>\n","protected":false},"author":12,"featured_media":2315279,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"","fifu_image_alt":"","footnotes":""},"categories":[],"tags":[],"class_list":["post-1199801","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1199801","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=1199801"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/1199801\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2315279"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=1199801"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=1199801"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=1199801"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}