{"id":324683,"date":"2021-08-15T03:14:35","date_gmt":"2021-08-15T00:14:35","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/peacetime-at-the-fda\/"},"modified":"2021-08-15T03:14:35","modified_gmt":"2021-08-15T00:14:35","slug":"peacetime-at-the-fda","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/peacetime-at-the-fda\/","title":{"rendered":"#Peacetime at the FDA"},"content":{"rendered":"<p>&#8220;<strong>#Peacetime at the FDA<\/strong>&#8221;<br \/>\n<img decoding=\"async\" src=\"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2021\/08\/AP21224581432037.jpg?quality=90&amp;strip=all\" \/><\/p>\n<div>\n<aside class=\"single__inline-module alignleft\">\n        <\/aside>\n<p>With the Delta variant continuing to surge, President <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.whitehouse.gov\/briefing-room\/statements-releases\/2021\/08\/09\/statement-by-president-joe-biden-on-covid-19-vaccines-for-service-members\/\">Joe Biden claims<\/a>, \u201cWe are still on a wartime footing, and every American who is eligible should take im<a href=\"https:\/\/buradabiliyorum.com\/en\/category\/social-mediaa\/\" data-internallinksmanager029f6b8e52c=\"1\" title=\"Social Media\" target=\"_blank\" rel=\"noopener\">media<\/a>te steps to get vaccinated right away.\u201d<\/p>\n<p>But his Food and Drug Administration is already back in peacetime, dragging its feet on giving final OK to the vaccines that have gone into 165 million American arms. More, it has stopped giving new emergency <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/download-scripts-themes-apps\/\" data-internallinksmanager029f6b8e52c=\"9\" title=\"Download Scripts &amp; Themes &amp; Apps\" target=\"_blank\" rel=\"noopener\">app<\/a>rovals for anti-COVID treatments and <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/technology\/\" data-internallinksmanager029f6b8e52c=\"4\" title=\"Technology\" target=\"_blank\" rel=\"noopener\">technology<\/a>, and is even rescinding some it made over the last year and a half.<\/p>\n<p>Biden needs to take a page from his predecessor and kick the agency out of its normal plodding pace.<\/p>\n<p>Yet he doesn\u2019t seem to have a clue: Seven months in office amid the pandemic, he hasn\u2019t even nominated a permanent FDA head. That\u2019s pretty \u201cpeacetime.\u201d<\/p>\n<p>A day after his \u201cwartime footing\u201d brag, Biden told reporters, \u201cGod willing, the FDA is going to be coming out in a reasonable time frame to say this vaccine is totally safe.<br \/>God willing? It\u2019s <em>your<\/em> will that\u2019s lacking here, sir.<\/p>\n<p>Biden\u2019s top medical adviser, Anthony Fauci, says the absence of permanent approval is just a \u201ctechnicality\u201d and Americans should act as if it\u2019s real.<\/p>\n<p><em>Should<\/em>, sure, but such talk won\u2019t persuade the vax-hesitant. Three in 10 unvaccinated adults say they\u2019d be more likely to get jabbed if a vaccine got full approval, <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.kff.org\/coronavirus-covid-19\/poll-finding\/kff-covid-19-vaccine-monitor-june-2021\/\">the Kaiser Family Foundation found<\/a>. That rises to half in the \u201cwait and see\u201d unvaxxed group.<\/p>\n<p>It\u2019s the No. 1 thing that would move vax hesitancy \u2014 even $100 payments only move the needle for 15 percent, Kaiser determined.<\/p>\n<p>Yet all signs are that the FDA won\u2019t give full approval to Pfizer\u2019s jab (the first of three to get emergency-use OK last year) before September.<\/p>\n<p>Heck, it seems to be actively stalling: \u201cThey required two extra months of safety data after the clinical trial was done, which is not really normal either,\u201d <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/www.fox13news.com\/news\/full-fda-approval-of-pfizer-biontech-vaccine-expected-in-september\">notes University of South Florida Health virologist Michael Teng<\/a>.<\/p>\n<p>And FDA leaders have delegated the approval \u2014 as per \u201cpeacetime\u201d practice \u2014 to the Center for Biologics Evaluation and Research Office for Vaccines Research and Review, the Office of Biostatistics and the Office of Compliance. How many levels of bureaucracy do we need \u201con a wartime footing\u201d?<\/p>\n<p>Meanwhile, White House officials say Biden may take weeks to even pick a successor to Janet Woodcock, the acting commissioner. The prez said recently, \u201cWe\u2019re working on that very hard to make sure we can get it passed,\u201d implying his team can\u2019t find a nominee it thinks will get Senate confirmation. It should be easy enough, <em>if<\/em> you pick someone nonpolitical.<\/p>\n<p>Yes, the FDA gave emergency-use authorization to monoclonal antibody treatment REGEN-COV last month, but that\u2019s an exception. Meanwhile, it rescinded the OK for investigational monoclonal antibody therapy bamlanivimab, when administered alone, in April and last month barred providers from using unapproved respirators or reusing disinfected respirators, deciding the supply of N95 masks was enough.<\/p>\n<p>\u201cIt\u2019s very similar to a recall,\u201d Marcus Schabacker of health-care safety group ECRI told Modern Healthcare, noting that providers constantly need to track what \u00a0the FDA still allows.<\/p>\n<p>It\u2019s lunacy to handcuff frontline health professionals working to stave off the surge and madness to simply <em>pray<\/em> for FDA action on the jabs.<\/p>\n<p>Biden is in charge of the FDA. He should start acting like it.\n                        <\/p><\/div>\n<blockquote><p><strong><span style=\"color: #ff6600;\">If you liked the article, do not forget to share it with your friends. Follow us on\u00a0<span style=\"color: #ff0000;\"><a style=\"color: #ff0000;\" href=\"https:\/\/news.google.com\/publications\/CAAqBwgKMLG0nwswvr63Aw\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">Google News<\/a><\/span>\u00a0too, click on the star and choose us from your favorites.<\/span><\/strong><\/p><\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\">For forums sites go to <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/forum.buradabiliyorum.com\/\" target=\"_blank\" rel=\"noopener\">Forum.BuradaBiliyorum.Com<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\"><strong>If you want to read more <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/news\/\" data-internallinksmanager029f6b8e52c=\"2\" title=\"News\" target=\"_blank\" rel=\"noopener\">News<\/a> articles, you can visit our <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/en.buradabiliyorum.com\/news\/\" target=\"_blank\" rel=\"noopener\">News category.<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<p><span style=\"color: black;\"><a style=\"color: #ff9900;\" href=\"https:\/\/nypost.com\/2021\/08\/14\/peacetime-at-the-fda\/\" target=\"_blank\" rel=\"noopener\">Source<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&#8220;#Peacetime at the FDA&#8221; With the Delta variant continuing to surge, President Joe Biden claims, \u201cWe are still on a wartime footing, and every American who is eligible should take immediate steps to get vaccinated right away.\u201d But his Food and Drug Administration is already back in peacetime, dragging its feet on giving final OK&#8230;<\/p>\n","protected":false},"author":1,"featured_media":324684,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/nypost.com\/wp-content\/uploads\/sites\/2\/2021\/08\/AP21224581432037.jpg?quality=90&strip=all&w=1024","fifu_image_alt":"","footnotes":""},"categories":[70897],"tags":[114240,1545,82862,43,74873,991],"class_list":["post-324683","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-8-14-21","tag-coronavirus","tag-covid-vaccine","tag-editorial","tag-fda","tag-joe-biden"],"_links":{"self":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/324683","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/comments?post=324683"}],"version-history":[{"count":0,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/324683\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media\/324684"}],"wp:attachment":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media?parent=324683"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/categories?post=324683"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/tags?post=324683"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}