{"id":3622,"date":"2016-07-20T09:07:40","date_gmt":"2016-07-20T13:07:40","guid":{"rendered":"https:\/\/medicarereport.org\/?p=3622"},"modified":"2016-07-20T09:07:40","modified_gmt":"2016-07-20T13:07:40","slug":"fda-sanctions-off-label-drug-promotion","status":"publish","type":"post","link":"https:\/\/medicarereport.org\/?p=3622","title":{"rendered":"FDA Sanctions Off-Label Drug Promotion"},"content":{"rendered":"<p>(By Deborah Mazer and Gregory Curfman, for Health <em>Affairs<\/em> Blog, July 19, 2016)<\/p>\n<p>Physicians have the authority to prescribe drugs for any reason they believe will benefit the patient, regardless of whether the use is on- or off-label. Off-label prescription is neither illegal nor unethical when based on the best available evidence.<\/p>\n<p>By contrast, <a href=\"http:\/\/www.healthaffairs.org\/healthpolicybriefs\/brief.php?brief_id=159\">off-label promotion<\/a>\u2014unlike off-label use\u2014has heretofore invited legal liability including criminal charges, penalties under the False Claims Act, and misbranding actions by the Food and Drug Administration (FDA). Opponents of off-label promotion argue that the off-label uses have not passed scrutiny by the FDA, the chief regulatory body charged with ensuring both efficacy and safety for specific indications of drugs. <a href=\"http:\/\/healthaffairs.org\/blog\/2016\/07\/19\/fda-sanctions-off-label-drug-promotion\/\" target=\"_blank\">Read article here&#8230;..<\/a><\/p>\n<p><span style=\"font-family: 'Arial','sans-serif';\"><span style=\"color: #000000;\">Copyright \u00a92015\u00a0<em>Health Affairs<\/em><\/span><span style=\"color: #000000;\"> by Project HOPE \u2013 The People-to-People Health Foundation, Inc.<\/span><\/span><\/p>\n<pre><strong>Notice<\/strong>: The link provided above connects readers to the full content of the posted article. The URL (internet address) for this link is valid on the posted date; medicarereport.org cannot guarantee the duration of the link\u2019s validity. Also, the opinions expressed in these postings are the viewpoints of the original source and are not explicitly endorsed by AMAC, Inc.; the AMAC Foundation, Inc.; or medicarereport.org.<\/pre>\n","protected":false},"excerpt":{"rendered":"<p>(By Deborah Mazer and Gregory Curfman, for Health Affairs Blog, July 19, 2016) Physicians have the authority to prescribe drugs<\/p>\n","protected":false},"author":5,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10,15],"tags":[],"class_list":["post-3622","post","type-post","status-publish","format-standard","hentry","category-legislative-update","category-part-dprescription-drugs"],"_links":{"self":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts\/3622","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3622"}],"version-history":[{"count":1,"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts\/3622\/revisions"}],"predecessor-version":[{"id":3623,"href":"https:\/\/medicarereport.org\/index.php?rest_route=\/wp\/v2\/posts\/3622\/revisions\/3623"}],"wp:attachment":[{"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3622"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3622"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medicarereport.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3622"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}