{"id":322,"date":"2022-06-28T16:12:05","date_gmt":"2022-06-28T20:12:05","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=322"},"modified":"2022-06-28T16:12:05","modified_gmt":"2022-06-28T20:12:05","slug":"doj-clarifies-position-on-fraud-on-the-fda-theory-of-false-claims-act-liability","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2022\/06\/28\/doj-clarifies-position-on-fraud-on-the-fda-theory-of-false-claims-act-liability\/","title":{"rendered":"DOJ Clarifies Position on Fraud-on-the-FDA Theory of False Claims Act Liability"},"content":{"rendered":"<p>On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator\u2019s action in the Southern District of Florida, arguing that \u201c[c]onduct giving rise to a regulatory violations can also give rise to [False Claims Act] liability.\u201d Specifically, requesting \u201cthat the ruling not foreclose the possibility that, under certain circumstances, conduct giving rise to violations of the [Federal Food, Drug and Cosmetic Act] or FDA regulations could be material to the government\u2019s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,\u201d also known as \u201cfraud on the FDA.\u201d<\/p>\n<p>To read the full text of this <em>Alert<\/em>, please <a href=\"https:\/\/www.duanemorris.com\/alerts\/doj_clarifies_position_fraud_fda_theory_false_claims_act_liability_0622.html\" target=\"_blank\" rel=\"noopener\">visit the firm website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator\u2019s action in the Southern District of Florida, arguing that \u201c[c]onduct giving rise to a regulatory violations can also give rise to [False Claims Act] liability.\u201d Specifically, requesting \u201cthat the ruling not foreclose the possibility that, &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2022\/06\/28\/doj-clarifies-position-on-fraud-on-the-fda-theory-of-false-claims-act-liability\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;DOJ Clarifies Position on Fraud-on-the-FDA Theory of False Claims Act Liability&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[338,341,29,608,574],"ppma_author":[521],"class_list":["post-322","post","type-post","status-publish","format-standard","hentry","category-general","tag-doj","tag-false-claims-act","tag-fda","tag-fraud-on-the-fda","tag-u-s-department-of-justice"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/322","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=322"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/322\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=322"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=322"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=322"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=322"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}