{"id":3669,"date":"2005-06-01T00:00:00","date_gmt":"2005-06-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/index.php\/2005\/06\/01\/pmn46-article04\/"},"modified":"2019-02-18T18:08:34","modified_gmt":"2019-02-18T18:08:34","slug":"pmn46-article04","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/","title":{"rendered":"Is an FDA Drug Risk Advisory System Needed? Survey Results"},"content":{"rendered":"<p>Is an FDA Drug Risk Advisory System Needed?        Survey Results<br \/>A high-ranking FDA official acknowledged in an appearance before the Institute of Medicine that the agency&#8217;s system for ensuring the safety of drugs is &#8220;pretty much broken down&#8221; and it has known for a long time it needed to improve its system. Recently the FDA published guidelines for a Drug Watch program to provide emerging drug safety information to the public. However, Senator Grassley and others have criticized the FDA&#8217;s new drug safety board, which is tasked with determining which drugs will be included in the program.  <\/p>\n<p> The Drug Risk Survey posed questions about the FDA&#8217;s proposed Drug Watch program as well as a Drug Risk Advisory System proposed by John Mack, publisher and editor of this newsletter (see &#8220;<a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmn45-article01.pdf\">A Proposal for a Drug Risk Advisory System<\/a>&#8220;). This article will provide an edited summary of the results with additional commentary. <\/p>\n<p> Topics covered include:  <\/p>\n<ul type=\"DISC\">\n<li>Criticism From All Sides <\/li>\n<li>Is FDA Backing Off?  <\/li>\n<li>Goldhammer&#8217;s (PhRMA&#8217;s) Statement to the IOM <\/li>\n<li>Drug Watch Site Proposal Summary <\/li>\n<li>Drug Risk Survey Results Regarding FDA&#8217;s Drug Watch Proposal:\n<ul>\n<li>Do you believe that a Drug Watch site such as proposed by the FDA is necessary? <\/li>\n<li>Is the Drug Watch program proposed by the FDA Too Cold (doesn&#8217;t go far enough), Just Right, or Too Hot (goes too far). <\/li>\n<li>Do you think the Drug Safety Oversight Board proposed by the FDA is independent enough and properly constituted with the right mix of experts? <\/li>\n<\/ul>\n<\/li>\n<li>Drug Risk Advisory System <\/li>\n<li>Drug Risk Survey Results Regarding Drug Risk Advisory System Proposal:\n<ul>\n<li>Chart of Responses <\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><b>Read this article now. It&#8217;s FREE&#8230;<\/b> <\/p>\n<p><b><a href=\"http:\/\/www.news.pharma-mkting.com\/pmn46-article04.pdf\">Download PDF file<\/a><\/b><\/p>\n<\/p>\n<hr\/>\n<p><b>Update<\/b> (December 2011): See the blog post below for a follow up on this issue. Also, to address a requirement of the 2010 Patient Protection and Affordable Care Act  (Affordable Care Act), FDA may be required to revisit this issue (see &#8220;<a href=\"http:\/\/www.forums.pharma-mkting.com\/showthread.php?t=67028\">FDA Summary of Drug Benefits vs Risks<\/a>&#8220;).<\/p>\n<p>  PMN46-04<br \/> Issue: Vol. 4, No. 6: June 2005<br \/> Word Count: 1888  <\/p>\n<p> <b>Find other articles in related Topic Areas:<\/b>  <\/p>\n<ul>\n<li><b>Pharma Marketing Blog<\/b> post: &#8220;<a href=\"http:\/\/pharma-mkting.com\/blog\/2007\/03\/drug-safety-mere-asterisk-to-fda.html\">Drug Safety &#8211; A Mere Asterisk to the FDA<\/a>&#8221; <\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNDTCReprints.htm\">Direct-to-Consumer (DTC) Advertising &amp; Marketing<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNRegComplianceReprints.htm\">Regulatory Compliance<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNstrategyReprints.htm\">Strategic Marketing &amp; Planning<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Preliminary results from The Drug Risk Survey, which posed questions about the FDA&#8217;s proposed Drug Watch program as well as the Drug Risk Advisory System proposed independently.<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[54,6],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Is an FDA Drug Risk Advisory System Needed? Survey Results - 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\/articles\/pmn46-article04\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Is an FDA Drug Risk Advisory System Needed? Survey Results - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Preliminary results from The Drug Risk Survey, which posed questions about the FDA&#039;s proposed Drug Watch program as well as the Drug Risk Advisory System proposed independently.\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2005-06-01T00:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-18T18:08:34+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/03\/pmn-logo-intro-post-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"744\" \/>\n\t<meta property=\"og:image:height\" content=\"419\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Pharma Guy\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Pharma Guy\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/\",\"name\":\"Is an FDA Drug Risk Advisory System Needed? Survey Results - Pharma Marketing Network\",\"isPartOf\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\"},\"datePublished\":\"2005-06-01T00:00:00+00:00\",\"dateModified\":\"2019-02-18T18:08:34+00:00\",\"author\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1\"},\"breadcrumb\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Is an FDA Drug Risk Advisory System Needed? Survey Results\"}]},{\"@type\":\"WebSite\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/\",\"name\":\"Pharma Marketing Network\",\"description\":\"Pharma Marketing Network\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1\",\"name\":\"Pharma Guy\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/image\/\",\"url\":\"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g\",\"contentUrl\":\"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g\",\"caption\":\"Pharma Guy\"},\"description\":\"Pharmaguy\u2122 is a \u201cconstructive critic\u201d of pharma marketing and publishes commentary on the Pharma Marketing Blog and on Scoop.it.\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/author\/ehs-pharmaguy\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Is an FDA Drug Risk Advisory System Needed? Survey Results - Pharma Marketing Network","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/","og_locale":"en_US","og_type":"article","og_title":"Is an FDA Drug Risk Advisory System Needed? Survey Results - Pharma Marketing Network","og_description":"Preliminary results from The Drug Risk Survey, which posed questions about the FDA's proposed Drug Watch program as well as the Drug Risk Advisory System proposed independently.","og_url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/","og_site_name":"Pharma Marketing Network","article_published_time":"2005-06-01T00:00:00+00:00","article_modified_time":"2019-02-18T18:08:34+00:00","og_image":[{"width":744,"height":419,"url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/03\/pmn-logo-intro-post-1.jpg","type":"image\/jpeg"}],"author":"Pharma Guy","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Pharma Guy","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/","name":"Is an FDA Drug Risk Advisory System Needed? Survey Results - Pharma Marketing Network","isPartOf":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website"},"datePublished":"2005-06-01T00:00:00+00:00","dateModified":"2019-02-18T18:08:34+00:00","author":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1"},"breadcrumb":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/"]}]},{"@type":"BreadcrumbList","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn46-article04\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/"},{"@type":"ListItem","position":2,"name":"Is an FDA Drug Risk Advisory System Needed? Survey Results"}]},{"@type":"WebSite","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/","name":"Pharma Marketing Network","description":"Pharma Marketing Network","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1","name":"Pharma Guy","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/image\/","url":"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g","contentUrl":"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g","caption":"Pharma Guy"},"description":"Pharmaguy\u2122 is a \u201cconstructive critic\u201d of pharma marketing and publishes commentary on the Pharma Marketing Blog and on Scoop.it.","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/author\/ehs-pharmaguy\/"}]}},"_links":{"self":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/3669"}],"collection":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/comments?post=3669"}],"version-history":[{"count":1,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/3669\/revisions"}],"predecessor-version":[{"id":3740,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/3669\/revisions\/3740"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media\/13101"}],"wp:attachment":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media?parent=3669"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/categories?post=3669"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/tags?post=3669"},{"taxonomy":"topic","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/topic?post=3669"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}