{"id":49461,"date":"2025-01-26T21:51:00","date_gmt":"2025-01-26T21:51:00","guid":{"rendered":"https:\/\/peraltafinancing.com\/business\/legal\/fda-finalizes-guidance-on-siuu-and-distribution-of-off-label-information\/"},"modified":"2025-01-26T21:51:00","modified_gmt":"2025-01-26T21:51:00","slug":"fda-finalizes-guidance-on-siuu-and-distribution-of-off-label-information","status":"publish","type":"post","link":"https:\/\/fivemor.com\/?p=49461","title":{"rendered":"FDA Finalizes Guidance on SIUU and Distribution of Off Label Information"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div id=\"overview\">\n<p>Who among us, upon reading FDA\u2019s draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for <a href=\"https:\/\/www.thefdalawblog.com\/2023\/10\/from-grp-to-siuu-the-evolution-of-fda-guidance-on-off-label-dissemination-of-scientific-information\/\">Scientific Information on Unapproved Uses<\/a>) did not automatically think of Phil Collins\u2019 classic song <a href=\"https:\/\/www.youtube.com\/watch?v=r0qBaBb1Y-U\">Sussudio<\/a>?\u00a0 (Other than anyone under 50, that is.\u00a0 In any event, you whippersnappers should look up the album No Jacket Required \u2013 it\u2019s a classic.)<\/p>\n<p>In any event, in the waning days of the Biden Administration, the FDA finalized this gem.\u00a0 And in all seriousness, the finalization of this guidance is somewhat historic given that industry has been relying on various versions of draft \u201cGood Reprint Practices\u201d guidance since 2009.\u00a0 \u00a0This <a href=\"https:\/\/www.fda.gov\/media\/184871\/download\">final guidance<\/a> (16 years in the making!) is very similar to the draft guidance with a few notable exceptions:<\/p>\n<ul>\n<li>FDA expanded the list of source publications that can be used as the basis of firm generated presentations to include all the source publications that are permitted as SIUU (answering the call of all who read the draft guidance and wondered why reprints were given more weight than medical texts).<\/li>\n<li>FDA deleted the requirement that SIUU be \u201cclinically relevant\u201d and left only the requirement that the information be \u201cscientifically sound\u201d (thank you FDA \u2013 on behalf of industry, we are still getting used to the SASS standard from the CFL guidance and yet another evidentiary standard imposed on product communications was a bit much).<\/li>\n<li>FDA acknowledged that \u201cscientifically sound\u201d studies can include early stage studies and other studies that were not accepted under the draft guidance (can we get a \u201challelujah?\u201d).<\/li>\n<\/ul>\n<p>Other than these changes, reorganizing the guidance, and including a definitional section, the final version is quite similar to the draft.\u00a0 One other notable change is that the final guidance discusses the in person distribution of SIUU which was absent from the draft.\u00a0 The guidance states:<\/p>\n<blockquote>\n<p>FDA recommends that firms ensure that the personnel who are engaged in sharing SIUU communications have specialized training in providing truthful, non-misleading scientific information about unapproved uses of the firms\u2019 approved medical products.\u00a0 A firm\u2019s personnel who are sharing SIUU communications should also be trained to handle potential questions that may arise about the information they are sharing <strong><em>or know how to direct the questions to personnel who are best qualified to respond (e.g., medical or scientific\/technical representative or department)<\/em><\/strong>.\u00a0 (Guidance at 19, n.49)<\/p>\n<\/blockquote>\n<p>This is notable as it suggests that the personnel engaged in sharing SIUU apparently do NOT have to be within the medical affairs department. \u00a0This vague set of instructions may cause companies to ask what precisely the limits are for in\u00a0 person sharing of SIUU.\u00a0 We know with certainty, however, that promotional communications and scientific communications must lead \u201c<a href=\"https:\/\/www.youtube.com\/watch?v=bqvgtlebx8c\">separate lives<\/a>\u201d so to speak.<\/p>\n<p>While not a remarkable change from the draft guidance, we welcome the loosening of some of the restrictions as noted above.\u00a0 Even if it is <a href=\"https:\/\/www.youtube.com\/watch?v=SWSQS06i7-w\">against all odds<\/a> we welcome anything that more closely aligns FDA\u2019s regulatory positions with the First Amendment.<\/p>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>Who among us, upon reading FDA\u2019s draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses) did not automatically think of Phil Collins\u2019 classic song Sussudio?\u00a0 (Other than anyone under 50, that is.\u00a0 In any event, you whippersnappers should look up the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4302,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[97],"tags":[20740,19889,11308,13319,6594,2036,29452],"dealstore":[],"offerexpiration":[],"class_list":["post-49461","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legal","tag-distribution","tag-fda","tag-finalizes","tag-guidance","tag-information","tag-label","tag-siuu"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Finalizes Guidance on SIUU and Distribution of Off Label Information - Som2ny Network<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fivemor.com\/?p=49461\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta 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