{"id":31,"date":"2020-10-24T12:31:21","date_gmt":"2020-10-24T17:31:21","guid":{"rendered":"https:\/\/betterpathology.com\/?page_id=31"},"modified":"2021-10-16T17:36:40","modified_gmt":"2021-10-16T22:36:40","slug":"better-pathology","status":"publish","type":"page","link":"https:\/\/betterpathology.com\/","title":{"rendered":"Better Pathology"},"content":{"rendered":"\n<p class=\"has-text-align-center has-accent-color has-text-color\"><em>Connecting people with information needed to live their best possible lives<\/em>.<\/p>\n\n\n<ul class=\"wp-block-latest-posts__list has-dates has-author wp-block-latest-posts\"><li><a class=\"wp-block-latest-posts__post-title\" href=\"https:\/\/betterpathology.com\/?p=1877\">Emergency Use Authorizations in a Post-Emergency World<\/a><div class=\"wp-block-latest-posts__post-author\">by Kevin Homer, MD<\/div><time datetime=\"2023-03-12T18:35:11-05:00\" class=\"wp-block-latest-posts__post-date\">March 12, 2023<\/time><div class=\"wp-block-latest-posts__post-full-content\"><!-- wp:image {\"id\":1876,\"sizeSlug\":\"large\",\"linkDestination\":\"none\"} -->\n<figure class=\"wp-block-image size-large\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" width=\"580\" height=\"384\" data-attachment-id=\"1876\" data-permalink=\"https:\/\/betterpathology.com\/?attachment_id=1876\" data-orig-file=\"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?fit=2516%2C1667&amp;ssl=1\" data-orig-size=\"2516,1667\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;10&quot;,&quot;credit&quot;:&quot;Nils Versemann&quot;,&quot;camera&quot;:&quot;PENTAX K-50&quot;,&quot;caption&quot;:&quot;Hospital emergency room sign outside an Australian hospital&quot;,&quot;created_timestamp&quot;:&quot;1414334453&quot;,&quot;copyright&quot;:&quot;\\u00a9 Nils Versemann&quot;,&quot;focal_length&quot;:&quot;24&quot;,&quot;iso&quot;:&quot;250&quot;,&quot;shutter_speed&quot;:&quot;0.008&quot;,&quot;title&quot;:&quot;Hospital emergency room sign&quot;,&quot;orientation&quot;:&quot;0&quot;}\" data-image-title=\"Hospital emergency room sign\" data-image-description=\"\" data-image-caption=\"&lt;p&gt;Hospital emergency room sign outside an Australian hospital&lt;\/p&gt;\n\" data-large-file=\"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?fit=580%2C384&amp;ssl=1\" src=\"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?resize=580%2C384&#038;ssl=1\" alt=\"\" class=\"wp-image-1876\" srcset=\"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?resize=1024%2C678&amp;ssl=1 1024w, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?resize=300%2C199&amp;ssl=1 300w, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?resize=768%2C509&amp;ssl=1 768w, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?resize=1536%2C1018&amp;ssl=1 1536w, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?resize=2048%2C1357&amp;ssl=1 2048w, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?resize=1200%2C795&amp;ssl=1 1200w, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?resize=1980%2C1312&amp;ssl=1 1980w, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2023\/03\/82341021_m.jpg?w=1740&amp;ssl=1 1740w\" sizes=\"auto, (max-width: 580px) 100vw, 580px\" \/><\/figure>\n<!-- \/wp:image -->\n\n<!-- wp:paragraph -->\n<p>According to the U.S. Department of Health and Human Services (HHS), the COVID-19 Public Health Emergency will expire in May, but Emergency Use Authorizations and liability protection will continue after the emergency ends.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>Early in the pandemic, we were told that\u00a0<a href=\"https:\/\/betterpathology.com\/?p=217\">Emergency Use Authorizations<\/a>\u00a0were necessary to make unlicensed, unapproved tests, vaccines, and treatments available during an emergency.\u00a0\u00a0On\u00a0<a href=\"https:\/\/aspr.hhs.gov\/legal\/PHE\/Pages\/2019-nCoV.aspx\">January 31, 2020<\/a>, the Health and Human Services Secretary declared the COVID-19 pandemic a public health emergency, paving the way for these products.\u00a0\u00a0The secretary even invoked the liability protection of the\u00a0<a href=\"https:\/\/aspr.hhs.gov\/legal\/PREPact\/Pages\/default.aspx\">PREP Act<\/a>\u00a0to encourage manufacturing of countermeasures.\u00a0\u00a0Soon, the\u00a0<a href=\"https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/emergency-use-authorization#covid19euas\">FDA<\/a>\u00a0began issuing Emergency Use Authorization letters which\u00a0<a href=\"https:\/\/www.fda.gov\/media\/150386\/download\">close<\/a>\u00a0with a notice that the authorization will terminate when the emergency is over.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>Last month, the HHS secretary signaled his intention to\u00a0<a href=\"https:\/\/www.hhs.gov\/coronavirus\/covid-19-public-health-emergency\/index.html\">end the emergency<\/a>\u00a0on May 11, 2023.\u00a0\u00a0At the same time, the secretary assured us that Emergency Use Authorizations will not be affected.\u00a0\u00a0According to the\u00a0<a href=\"https:\/\/www.hhs.gov\/about\/news\/2023\/02\/09\/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html\">statement<\/a>, \u201cExisting EUAs for COVID-19 products will remain in effect under Section 564 of the Federal Food, Drug, and Cosmetic Act, and the agency may continue to issue new EUAs going forward when criteria for issuance are met.\u201d<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>The Federal Food, Drug, and Cosmetic Act was amended several times by\u00a0the\u00a0<a href=\"https:\/\/www.congress.gov\/117\/bills\/hr2617\/BILLS-117hr2617enr.pdf\">Consolidated Appropriations Act, 2023<\/a>\u00a0(see page 1339, for example).\u00a0\u00a0Did these amendments give FDA authority to issue EUAs without an emergency?\u00a0\u00a0I cannot tell you because, frankly, I get lost in the language.\u00a0\u00a0HHS claims its authority for EUAs in the absence of an emergency declaration dates back a decade, to the\u00a0<a href=\"https:\/\/www.congress.gov\/113\/statute\/STATUTE-127\/STATUTE-127-Pg161.pdf\">Pandemic and All-Hazards Preparedness Reauthorization Act of 2013<\/a>.\u00a0\u00a0Regardless, the intention is clear: EUAs will continue after the emergency is lifted.<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>And what will become of those PREP Act liability protections?\u00a0\u00a0According to HHS, these will also continue, but only for a select group of manufacturers:<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:quote -->\n<blockquote class=\"wp-block-quote\"><!-- wp:paragraph -->\n<p><em>Currently, the amended PREP Act declaration provides liability immunity to manufacturers, distributors, public and private organizations conducting countermeasure programs, and providers for COVID-19 countermeasure activities related to a USG [United States Government] agreement (e.g., manufacturing, distribution, or administration of the countermeasures subject to a federal contract, provider agreement, or memorandum of understanding). That coverage will not be affected by the end of the PHE. However, PREP Act liability protections for countermeasure activities that are not related to any USG agreement (e.g., products entirely in the commercial sector or solely a state or local activity) will end unless another federal, state, or local emergency declaration is in place for area where countermeasures are administered. HHS is currently reviewing whether to continue to provide this coverage going forward.<\/em><\/p>\n<!-- \/wp:paragraph --><cite><a href=\"https:\/\/www.hhs.gov\/about\/news\/2023\/02\/09\/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html\">Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, February 9, 2023<\/a><\/cite><\/blockquote>\n<!-- \/wp:quote -->\n\n<!-- wp:paragraph -->\n<p>Manufacturers of EUA products that have an agreement with the US Government will continue to have liability protection.\u00a0\u00a0Other manufacturers will not.\u00a0\u00a0Collusion between the federal government and big businesses like this asymmetric post-emergency liability protection is the very definition of\u00a0<a href=\"https:\/\/betterpathology.com\/?p=1392\">fascism<\/a>.\u00a0\u00a0<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>If Emergency-Use-Authorizations without an emergency seem illogical to you, you are not alone.\u00a0\u00a0Even\u00a0<a href=\"https:\/\/www.newsweek.com\/untangling-america-never-ending-covid-state-emergency-opinion-1779252\">members of congress<\/a>\u00a0have assumed that EUAs will end with the emergency declaration.\u00a0\u00a0<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>This is not just an assault on language and logic.\u00a0\u00a0It is an assault on liberty.\u00a0\u00a0<\/p>\n<!-- \/wp:paragraph -->\n\n<!-- wp:paragraph -->\n<p>The emergency declaration will end soon, but the\u00a0<a href=\"https:\/\/betterpathology.com\/?p=1753\">emergency power-grab<\/a>\u00a0will continue indefinitely.<\/p>\n<!-- \/wp:paragraph --><\/div><\/li>\n<\/ul>\n\n\n<p><\/p>\n\n\n\n<p class=\"has-text-align-center\"><strong>+++<\/strong><\/p>\n\n\n\n<p class=\"has-text-align-center\"><strong>\u201cDr. Homer is one of my heroes!\u201d<\/strong><\/p>\n\n\n\n<p class=\"has-text-align-center\"><em>&#8211;Dr. Peter Navarro, October 16, 2021<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Connecting people with information needed to live their best possible lives. +++ \u201cDr. Homer is one of my heroes!\u201d &#8211;Dr. Peter Navarro, October 16, 2021<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"closed","template":"templates\/template-full-width.php","meta":{"nf_dc_page":"","om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"jetpack_post_was_ever_published":false,"footnotes":""},"class_list":["post-31","page","type-page","status-publish","hentry"],"jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":38,"url":"https:\/\/betterpathology.com\/?page_id=38","url_meta":{"origin":31,"position":0},"title":"Biography","author":"Kevin Homer, MD","date":"April 19, 2020","format":false,"excerpt":"Kevin Homer, MD President and Pathologist Kevin Homer, MD has extensive experience as a hospital based anatomic and clinical pathologist.\u00a0\u00a0Certified in anatomic and clinical pathology by the American Board of Pathology, with a subspecialty certification in cytopathology, Dr. Homer has practiced at Texas Health Huguley Hospital since completing a fellowship\u2026","rel":"","context":"Similar post","block_context":{"text":"Similar post","link":""},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]}],"_links":{"self":[{"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/pages\/31","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/betterpathology.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=31"}],"version-history":[{"count":5,"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/pages\/31\/revisions"}],"predecessor-version":[{"id":1132,"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/pages\/31\/revisions\/1132"}],"wp:attachment":[{"href":"https:\/\/betterpathology.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=31"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}