{"id":113337,"date":"2024-10-12T15:10:44","date_gmt":"2024-10-12T08:10:44","guid":{"rendered":"https:\/\/hotvideos24.online\/?p=113337"},"modified":"2024-10-12T15:10:44","modified_gmt":"2024-10-12T08:10:44","slug":"us-fda-to-reconsider-decision-barring-compounded-versions-of-lilly-weight-loss-drug","status":"publish","type":"post","link":"https:\/\/hotvideos24.online\/?p=113337","title":{"rendered":"US FDA to reconsider decision barring compounded versions of Lilly weight loss drug"},"content":{"rendered":"<p> <script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3711241968723425\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-format=\"fluid\"\r\n     data-ad-layout-key=\"-fb+5w+4e-db+86\"\r\n     data-ad-client=\"ca-pub-3711241968723425\"\r\n     data-ad-slot=\"7910942971\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script><br \/>\n<\/p>\n<div>\n<div data-testid=\"ContextWidget\" class=\"context-widget__container__3fXK0 context-widget__with-scroll__1cg1b article-body__context_widget__1xxEe\">\n<div class=\"context-widget__content__1X4Oq\">\n<ul data-testid=\"Summary\" class=\"summary__summary__31feP\">\n<li data-testid=\"Body\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__base__22dCE body__small_body__2vQyf summary__point__NO-2F\">FDA to review if there&#8217;s a shortage of tirzepatide<\/li>\n<li data-testid=\"Body\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__base__22dCE body__small_body__2vQyf summary__point__NO-2F\">Outsourcing Facilities Association lawsuit led to FDA reconsideration<\/li>\n<li data-testid=\"Body\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__base__22dCE body__small_body__2vQyf summary__point__NO-2F\">Shortages of Lilly and Novo Nordisk drugs drive demand for compounded versions<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div data-testid=\"paragraph-0\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__full_width__ekUdw body__small_body__2vQyf article-body__paragraph__2-BtD\">Oct 11 (Reuters) &#8211; The U.S. Food and Drug Administration on Friday agreed to reconsider a decision it made last month to bar drug compounders from selling their own versions of Eli Lilly&#8217;s <a data-testid=\"Link\" target=\"_blank\" href=\"https:\/\/www.reuters.com\/markets\/companies\/LLY.N\" referrerpolicy=\"no-referrer-when-downgrade\" rel=\"noopener\" class=\"text__text__1FZLe text__inherit-color__3208F text__inherit-font__1Y8w3 text__inherit-size__1DZJi link__link__3Ji6W link__underline_default__2prE_ link__with-icon__3x3oD\">(LLY.N)<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 32 32\" aria-hidden=\"true\" focusable=\"false\" role=\"presentation\" data-testid=\"NewTabSymbol\" class=\"link__new-tab-symbol__3T19s\"><path fill=\"#666\" d=\"M15 6c.6 0 1 .4 1 1s-.4 1-1 1H9c-.6 0-1 .4-1 1v14a1.1 1.1 0 0 0 .2.6c.1.2.4.4.8.4h14c.6 0 1-.4 1-1v-6c0-.6.4-1 1-1s1 .4 1 1v6a3 3 0 0 1-3 3H9a3 3 0 0 1-2.2-.9A3 3 0 0 1 6 23V9a3 3 0 0 1 3-3Zm10 0 .4.1.5.5.1.4v6c0 .6-.4 1-1 1s-1-.4-1-1V9.4l-5.3 5.3a1 1 0 0 1-.7.3 1 1 0 0 1-.7-.3 1 1 0 0 1 0-1.4L22.6 8H19c-.6 0-1-.4-1-1s.4-1 1-1Z\"\/><\/svg><span style=\"border:0;clip:rect(0 0 0 0);clip-path:inset(50%);height:1px;margin:-1px;overflow:hidden;padding:0;position:absolute;width:1px;white-space:nowrap\">, opens new tab<\/span><\/a> blockbuster weight loss and diabetes drugs.<\/div>\n<p>The agency said in a court filing it would now allow compounding pharmacies and facilities to keep providing the drugs while it reviews whether there is a shortage of their active ingredient. The compounding versions of the drugs are cheaper for patients than the brand-name versions.<\/p>\n<div data-testid=\"paragraph-2\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__full_width__ekUdw body__small_body__2vQyf article-body__paragraph__2-BtD\">The decision was in response to <a data-testid=\"Link\" href=\"https:\/\/www.reuters.com\/legal\/compounding-group-sues-fda-removing-lillys-weight-loss-drug-shortage-list-2024-10-07\/\" referrerpolicy=\"no-referrer-when-downgrade\" class=\"text__text__1FZLe text__inherit-color__3208F text__inherit-font__1Y8w3 text__inherit-size__1DZJi link__link__3Ji6W link__underline_default__2prE_\">a lawsuit<\/a> brought on Monday by the Outsourcing Facilities Association, a compounding industry group. After the FDA&#8217;s decision on Friday to reconsider, U.S. District Judge Mark Pittman in Fort Worth, Texas put the lawsuit on hold.<\/div>\n<div data-testid=\"paragraph-3\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__full_width__ekUdw body__small_body__2vQyf article-body__paragraph__2-BtD\">The Sept. 30 decision by the FDA endangered the ability of compounders to sell versions of Lilly&#8217;s weight loss drug Zepbound and diabetes drug Mounjaro. The FDA decision <a data-testid=\"Link\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-says-lillys-weight-loss-drug-no-longer-shortage-2024-10-02\/\" referrerpolicy=\"no-referrer-when-downgrade\" class=\"text__text__1FZLe text__inherit-color__3208F text__inherit-font__1Y8w3 text__inherit-size__1DZJi link__link__3Ji6W link__underline_default__2prE_\">removed their active ingredient<\/a>, tirzepatide, from its list of drugs experiencing shortages.<\/div>\n<p>That would have cut off access for many patients to the compounded versions they relied on during the shortage, which are cheaper than the brand name drugs. Insurers generally cover drugs like tirzepatide for diabetes, but many do not cover them for weight loss.<\/p>\n<p>Outsourcing Facilities Association Chairman Lee Rosebush said in a statement the group was &#8220;greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision.&#8221;<\/p>\n<div data-testid=\"paragraph-6\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__full_width__ekUdw body__small_body__2vQyf article-body__paragraph__2-BtD\">Shortages of Lilly&#8217;s drugs and competitors like Novo Nordisk&#8217;s <a data-testid=\"Link\" target=\"_blank\" href=\"https:\/\/www.reuters.com\/markets\/companies\/NOVOb.CO\" referrerpolicy=\"no-referrer-when-downgrade\" rel=\"noopener\" class=\"text__text__1FZLe text__inherit-color__3208F text__inherit-font__1Y8w3 text__inherit-size__1DZJi link__link__3Ji6W link__underline_default__2prE_ link__with-icon__3x3oD\">(NOVOb.CO)<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 32 32\" aria-hidden=\"true\" focusable=\"false\" role=\"presentation\" data-testid=\"NewTabSymbol\" class=\"link__new-tab-symbol__3T19s\"><path fill=\"#666\" d=\"M15 6c.6 0 1 .4 1 1s-.4 1-1 1H9c-.6 0-1 .4-1 1v14a1.1 1.1 0 0 0 .2.6c.1.2.4.4.8.4h14c.6 0 1-.4 1-1v-6c0-.6.4-1 1-1s1 .4 1 1v6a3 3 0 0 1-3 3H9a3 3 0 0 1-2.2-.9A3 3 0 0 1 6 23V9a3 3 0 0 1 3-3Zm10 0 .4.1.5.5.1.4v6c0 .6-.4 1-1 1s-1-.4-1-1V9.4l-5.3 5.3a1 1 0 0 1-.7.3 1 1 0 0 1-.7-.3 1 1 0 0 1 0-1.4L22.6 8H19c-.6 0-1-.4-1-1s.4-1 1-1Z\"\/><\/svg><span style=\"border:0;clip:rect(0 0 0 0);clip-path:inset(50%);height:1px;margin:-1px;overflow:hidden;padding:0;position:absolute;width:1px;white-space:nowrap\">, opens new tab<\/span><\/a> Ozempic have fueled demand for compounders&#8217; versions. Mounjaro had been on the FDA&#8217;s list of drugs in short supply since late 2022, while Zepbound was added in April.<\/div>\n<p>Compounded drugs, unlike conventional brand-name or generic drugs, are sold without first getting FDA approval. Compounding pharmacies may create drugs to fill prescriptions for specific patients, while so-called outsourcing facilities prepare compounded drugs in bulk.<\/p>\n<p>Federal regulations allow compounded versions of an FDA-approved drug to be sold to meet demand if the drug is in short supply. If there is no shortage of a drug, compounded versions of it cannot be made regularly or in large amounts.<\/p>\n<p>The Outsourcing Facilities Association claimed in its lawsuit the FDA removed tirzepatide from its shortage list even though it remained in short supply.<\/p>\n<div data-testid=\"paragraph-10\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__full_width__ekUdw body__small_body__2vQyf article-body__paragraph__2-BtD\">Lilly in August <a data-testid=\"Link\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/lilly-demands-doctors-stop-selling-copycat-weight-loss-drugs-bloomberg-reports-2024-08-14\/\" referrerpolicy=\"no-referrer-when-downgrade\" class=\"text__text__1FZLe text__inherit-color__3208F text__inherit-font__1Y8w3 text__inherit-size__1DZJi link__link__3Ji6W link__underline_default__2prE_\">began sending cease-and-desist letters<\/a> to telehealth companies, wellness centers and medical spas selling compounded versions of Zepbound and Mounjaro. The company has also <a data-testid=\"Link\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/lilly-files-additional-lawsuits-over-us-sales-counterfeit-mounjaro-2024-06-20\/\" referrerpolicy=\"no-referrer-when-downgrade\" class=\"text__text__1FZLe text__inherit-color__3208F text__inherit-font__1Y8w3 text__inherit-size__1DZJi link__link__3Ji6W link__underline_default__2prE_\">filed lawsuits<\/a> against sellers falsely claiming to sell FDA-approved versions of the drug.<\/div>\n<p>The active ingredient in Novo Nordisk&#8217;s drugs, semaglutide, remains on the FDA&#8217;s shortage list.<\/p>\n<p data-testid=\"promo-box\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__base__22dCE body__small_body__2vQyf article-body__promo-box__3bCm_\"> Sign up <!-- --> <a data-testid=\"Link\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/fda-reconsider-decision-barring-compounded-versions-lilly-weight-loss-drug-2024-10-11\/undefined?location=article-paragraph\" referrerpolicy=\"no-referrer-when-downgrade\" class=\"text__text__1FZLe text__inherit-color__3208F text__inherit-font__1Y8w3 text__inherit-size__1DZJi link__link__3Ji6W link__underline_default__2prE_\">here.<\/a><\/p>\n<div class=\"article-body__element__2p5pI\">\n<p data-testid=\"Body\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__extra_small__1Mw6v body__full_width__ekUdw body__extra_small_body__3QTYe sign-off__text__PU3Aj sign-off__no-margin-top__2e9N-\">Reporting By Brendan Pierson in New York; Editing by David Gregorio and Chris Reese<\/p>\n<\/div>\n<p data-testid=\"Body\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__base__22dCE body__small_body__2vQyf article-body__element__2p5pI article-body__trust-badge__D_brm\">Our Standards: <a data-testid=\"Link\" target=\"_blank\" href=\"https:\/\/www.thomsonreuters.com\/en\/about-us\/trust-principles.html\" referrerpolicy=\"no-referrer-when-downgrade\" rel=\"noopener\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__medium__1kbOh text__small__1kGq2 link__link__3Ji6W link__underline_default__2prE_ link__with-icon__3x3oD\">The Thomson Reuters Trust Principles.<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 32 32\" aria-hidden=\"true\" focusable=\"false\" role=\"presentation\" data-testid=\"NewTabSymbol\" class=\"link__new-tab-symbol__3T19s\"><path fill=\"#666\" d=\"M15 6c.6 0 1 .4 1 1s-.4 1-1 1H9c-.6 0-1 .4-1 1v14a1.1 1.1 0 0 0 .2.6c.1.2.4.4.8.4h14c.6 0 1-.4 1-1v-6c0-.6.4-1 1-1s1 .4 1 1v6a3 3 0 0 1-3 3H9a3 3 0 0 1-2.2-.9A3 3 0 0 1 6 23V9a3 3 0 0 1 3-3Zm10 0 .4.1.5.5.1.4v6c0 .6-.4 1-1 1s-1-.4-1-1V9.4l-5.3 5.3a1 1 0 0 1-.7.3 1 1 0 0 1-.7-.3 1 1 0 0 1 0-1.4L22.6 8H19c-.6 0-1-.4-1-1s.4-1 1-1Z\"\/><\/svg><span style=\"border:0;clip:rect(0 0 0 0);clip-path:inset(50%);height:1px;margin:-1px;overflow:hidden;padding:0;position:absolute;width:1px;white-space:nowrap\">, opens new tab<\/span><\/a><\/p>\n<div class=\"article-body__row__dFOPA article-body__element__2p5pI\"><a href=\"https:\/\/www.reutersagency.com\/en\/licensereuterscontent\/?utm_medium=rcom-article-media&amp;utm_campaign=rcom-rcp-lead\" target=\"_blank\" class=\"button__link__uTGln button__secondary__18moI button__round__1nYLA button__w_auto__6WYRo\" data-testid=\"LicenceContentButton\" rel=\"noopener\"><span class=\"button__container__3sgvk license-content-button__button__3okgd\"><span data-testid=\"Text\" class=\"text__text__1FZLe text__inherit-color__3208F text__regular__2N1Xr text__body_fixed__1I7Al license-content-button__text__3XBrA\">Purchase Licensing Rights<\/span><\/span><\/a><\/div>\n<div data-testid=\"AuthorBio\" class=\"article-body__element__2p5pI\">\n<address class=\"author-bio__author-card__3h9uA\">\n<div class=\"author-bio__author-wrapper__3HHLV\"><a class=\"author-bio__author-image__3uDqF\" href=\"https:\/\/www.reuters.com\/authors\/brendan-pierson\/\" referrerpolicy=\"no-referrer-when-downgrade\"><\/p>\n<div data-testid=\"Image\" class=\"author-bio__image__1d0O-\"><img decoding=\"async\" src=\"https:\/\/s3.amazonaws.com\/arc-authors\/reuters\/75c45489-f2d2-466a-9429-aeeb9ef3b6f1.png\"\/><\/div>\n<p><\/a><\/div>\n<p data-testid=\"Body\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__small__1kGq2 body__base__22dCE body__small_body__2vQyf author-bio__description__3uv33\" style=\"font-size:16px\">Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.<\/p>\n<\/address>\n<\/div>\n<\/div>\n<p><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3711241968723425\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-format=\"fluid\"\r\n     data-ad-layout-key=\"-fb+5w+4e-db+86\"\r\n     data-ad-client=\"ca-pub-3711241968723425\"\r\n     data-ad-slot=\"7910942971\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script><br \/>\n<br \/><div data-type=\"_mgwidget\" data-widget-id=\"1660802\">\r\n<\/div>\r\n<script>(function(w,q){w[q]=w[q]||[];w[q].push([\"_mgc.load\"])})(window,\"_mgq\");\r\n<\/script>\r\n<br \/>\n<br \/><a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/fda-reconsider-decision-barring-compounded-versions-lilly-weight-loss-drug-2024-10-11\/\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA to review if there&#8217;s a shortage of tirzepatide Outsourcing Facilities Association lawsuit led to FDA reconsideration Shortages of Lilly and Novo Nordisk drugs drive demand for compounded versions Oct &hellip; <a href=\"https:\/\/hotvideos24.online\/?p=113337\" class=\"more-link\">Read More<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-113337","post","type-post","status-publish","format-standard","hentry","category-business","entry"],"_links":{"self":[{"href":"https:\/\/hotvideos24.online\/index.php?rest_route=\/wp\/v2\/posts\/113337","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/hotvideos24.online\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/hotvideos24.online\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/hotvideos24.online\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/hotvideos24.online\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=113337"}],"version-history":[{"count":0,"href":"https:\/\/hotvideos24.online\/index.php?rest_route=\/wp\/v2\/posts\/113337\/revisions"}],"wp:attachment":[{"href":"https:\/\/hotvideos24.online\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=113337"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/hotvideos24.online\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=113337"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/hotvideos24.online\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=113337"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}