{"id":6059,"date":"2014-03-17T11:17:00","date_gmt":"2014-03-17T11:17:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/why-fda-approved-zohydro\/"},"modified":"2019-02-21T01:16:47","modified_gmt":"2019-02-21T01:16:47","slug":"why-fda-approved-zohydro","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/why-fda-approved-zohydro\/","title":{"rendered":"Why the FDA Approved Zohydro"},"content":{"rendered":"<p>The opiate Zohydro was approved by the FDA although that decision went against the recommendation of the agency\u2019s own advisory panel, which voted 11 to 2 against approving the drug because of its potential for abuse.<\/p>\n<p>More than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs called on the FDA to revoke its approval of Zohydro, &#8220;an opioid so powerful that a single dose could kill a child,&#8221; according to Public Citizen (see <a href=\"http:\/\/www.citizen.org\/pressroom\/pressroomredirect.cfm?ID=4093\">here<\/a>).<\/p>\n<p>In addition, &#8220;a group of more than 40 doctors is hoping to preempt its release by urging the FDA to reconsider its decision,&#8221; reports <i>Regulatory Focus<\/i> (see &#8220;<a href=\"http:\/\/www.forums.pharma-mkting.com\/showthread.php?t=90826&amp;highlight=Zohydro\">Docs v. Zohydro<\/a>&#8220;). &#8220;According to the letter penned by the doctors, Zohydro is five to 10 times stronger than its nearest equivalent, Vicodin, and has the potential to cause a severe rise in overdose deaths.&#8221;<\/p>\n<p>As <i>Regulatory Focus<\/i> reported (<a href=\"https:\/\/www.raps.org\/focus-online\/news\/news-article-view\/article\/4646\">here<\/a>), Senate Minority Leader Mitch McConnell sent a letter to FDA in February 2014 demanding to know why the agency had approved Zohydro.<\/p>\n<p>While reading the March 17, 2014 issue of the&nbsp;<i>New Yorker<\/i>&nbsp;magazine, I discovered this cartoon, which graphically depicts FDA&#8217;s typical drug approval process. I made a slight modification that explains why FDA approved Zohydro. <\/p>\n<p><a name='more'><\/a><\/p>\n<table align=\"center\" cellpadding=\"0\" cellspacing=\"0\" class=\"tr-caption-container\" style=\"margin-left: auto; margin-right: auto; text-align: center;\">\n<tbody>\n<tr>\n<td style=\"text-align: center;\"><a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2014\/03\/InsidFDACartoon.jpg\" imageanchor=\"1\" style=\"margin-left: auto; margin-right: auto;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2014\/03\/InsidFDACartoon.jpg\" height=\"400\" width=\"397\" \/><\/a><\/td>\n<\/tr>\n<tr>\n<td class=\"tr-caption\" style=\"text-align: center;\">Perhaps Mitch McConnell will include this version of the cartoon at a public hearing on the issue in the Senate.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The opiate Zohydro was approved by the FDA although that decision went against the recommendation of the agency\u2019s own advisory panel, which voted 11 to 2 against approving the drug because of its potential for abuse. More than 40 consumer organizations, health care agencies, addiction treatment providers, and community-based drug and alcohol prevention programs called [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11496,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[113,44,294],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Why the FDA Approved Zohydro - Pharma Marketing 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=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/why-fda-approved-zohydro\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Why the FDA Approved Zohydro - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"The opiate Zohydro was approved by the FDA although that decision went against the recommendation of the agency\u2019s own advisory panel, which voted 11 to 2 against approving the drug because of its potential for abuse. 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