{"id":27,"date":"2007-09-30T10:51:30","date_gmt":"2007-09-30T17:51:30","guid":{"rendered":"http:\/\/cchrstl.org\/wordpress\/?p=27"},"modified":"2024-07-14T05:44:36","modified_gmt":"2024-07-14T10:44:36","slug":"the-food-and-drug-administration-amendments-act-of-2007-hr-3580","status":"publish","type":"post","link":"https:\/\/www.cchrstl.org\/wordpress\/2007\/09\/30\/the-food-and-drug-administration-amendments-act-of-2007-hr-3580\/","title":{"rendered":"The Food and Drug Administration Amendments Act of 2007 (H.R. 3580)"},"content":{"rendered":"<p><meta content=\"Microsoft Word 11 (filtered)\" name=\"Generator\" \/><\/p>\n<style>      <!--   \/* Font Definitions *\/   @font-face  \t{font-family:Wingdings;  \tpanose-1:5 0 0 0 0 0 0 0 0 0;}  @font-face  \t{font-family:Verdana;  \tpanose-1:2 11 6 4 3 5 4 4 2 4;}  @font-face  \t{font-family:AntiquaSSK;  \tpanose-1:0 0 4 0 0 0 0 0 0 0;}  @font-face  \t{font-family:Tahoma;  \tpanose-1:2 11 6 4 3 5 4 4 2 4;}   \/* Style Definitions *\/   p.MsoNormal, li.MsoNormal, div.MsoNormal  \t{margin:0in;  \tmargin-bottom:.0001pt;  \tfont-size:12.0pt;  \tfont-family:Verdana;}  h1  \t{margin-top:12.0pt;  \tmargin-right:0in;  \tmargin-bottom:3.0pt;  \tmargin-left:0in;  \tpage-break-after:avoid;  \tfont-size:16.0pt;  \tfont-family:Arial;  \tfont-weight:bold;}  h2  \t{margin-top:12.0pt;  \tmargin-right:0in;  \tmargin-bottom:3.0pt;  \tmargin-left:0in;  \tpage-break-after:avoid;  \tfont-size:14.0pt;  \tfont-family:Arial;  \tfont-weight:bold;  \tfont-style:italic;}  h3  \t{margin-right:0in;  \tmargin-left:0in;  \tfont-size:13.5pt;  \tfont-family:\"Times New Roman\";  \tfont-weight:bold;}  a:link, span.MsoHyperlink  \t{color:blue;  \ttext-decoration:underline;}  a:visited, span.MsoHyperlinkFollowed  \t{color:purple;  \ttext-decoration:underline;}  p  \t{margin-right:0in;  \tmargin-left:0in;  \tfont-size:12.0pt;  \tfont-family:\"Times New Roman\";}  p.CCHRHeading, li.CCHRHeading, div.CCHRHeading  \t{margin-top:12.0pt;  \tmargin-right:0in;  \tmargin-bottom:3.0pt;  \tmargin-left:0in;  \ttext-align:center;  \tpage-break-after:avoid;  \tfont-size:18.0pt;  \tfont-family:AntiquaSSK;  \tfont-weight:bold;}  @page Section1  \t{size:8.5in 11.0in;  \tmargin:1.0in 1.25in 1.0in 1.25in;}  div.Section1  \t{page:Section1;}  --><\/style>\n<div class=\"Section1\">\n<p class=\"MsoNormal\" style=\"text-align: center\" align=\"center\"><strong><em>Congress gave final approval Thursday, November 20, 2007 \u00c3\u201a\u00c2\u00a0to legislation designed to transform the Food and Drug Administration from a passive monitor to an active detective seeking out medications that have been approved for sale but turn out to be hazardous.<\/em><\/strong><\/p>\n<p class=\"MsoNormal\" style=\"text-align: center\" align=\"center\"><strong><em><\/em><\/strong><\/p>\n<p class=\"MsoNormal\">The <a href=\"http:\/\/www.govtrack.us\/congress\/bill.xpd?bill=h110-3580\">Food and Drug Administration Amendments Act of 2007 (H.R. 3580) <\/a>passed by unanimous consent in the Senate after the House overwhelmingly passed it the day before,\u00c3\u201a\u00c2\u00a0and the bill has been signed into law by the President.<\/p>\n<p class=\"MsoNormal\">\u00c3\u201a\u00c2\u00a0<\/p>\n<p class=\"MsoNormal\"><span style=\"font-size: 13.5pt\">Thank you for for supporting CCHR, helping it and its allies achieve what the media are heralding as the, <\/span><strong><span style=\"font-size: 13.5pt; color: red\">\u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cmost significant drug safety legislation in more than 40 years.\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d<\/span><\/strong><\/p>\n<p class=\"MsoNormal\"><strong><span style=\"font-size: 13.5pt; color: red\"><\/span><\/strong><\/p>\n<p class=\"MsoNormal\"><span style=\"font-size: 13.5pt; color: black; font-family: Tahoma\">Overcoming <em>unbelievable<\/em> obstacles, and working with many consumer and parents groups and whistleblowers, in a nutshell the following is some of what was achieved:<\/span><\/p>\n<p class=\"MsoNormal\"><span style=\"font-size: 13.5pt; color: black; font-family: Tahoma\"><\/span><\/p>\n<p><span style=\"font-size: 13.5pt; color: black; font-family: Tahoma\"><\/span><span style=\"font-size: 13.5pt; color: black; font-family: Tahoma\"><\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\"><span style=\"font-size: 13.5pt; font-family: Wingdings\">\u00c3\u201a\u00c2\u00a7<\/span><span style=\"font-size: 7pt; font-family: 'Times New Roman'\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 <\/span><span style=\"font-size: 13.5pt; color: black; font-family: Tahoma\">Drug ads will now carry a conspicuous notice: <\/span><span style=\"font-size: 13.5pt; font-family: Tahoma\">\u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201cYou are encouraged to report negative side effects of prescription drugs to the FDA. Visit <a href=\"http:\/\/www.fda.gov\/medwatch\">www.fda.gov\/medwatch<\/a> or call 1-800-FDA-1088.\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d\u00c3\u201a\u00c2\u00a0 Until now, over 90% of Americans didn\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u201e\u00a2t know that they could bypass their psych or MD to report adverse drug reactions (ADRs) to the FDA (because psychs\/doctors only report 1-10 percent of drug side effects.) Empowering people with the ability to report side effects themselves and the ADR reports could increase 100x! And $225 million is to be allocated to ensure that the FDA does oversee the adverse reactions and acts on them!<\/span><\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\"><span style=\"font-size: 13.5pt; font-family: Tahoma\"><\/span><\/p>\n<p><span style=\"font-size: 13.5pt; font-family: Tahoma\"><\/span><\/span><span style=\"font-size: 13.5pt; font-family: Tahoma\"><\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\"><span style=\"font-size: 13.5pt; font-family: Wingdings\">\u00c3\u201a\u00c2\u00a7<\/span><span style=\"font-size: 7pt; font-family: 'Times New Roman'\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 <\/span><span style=\"font-size: 13.5pt; font-family: Tahoma\">Drug companies must now publicly post all results\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u20ac\u009dthe good, bad and the ugly\u00c3\u00a2\u00e2\u201a\u00ac\u00e2\u20ac\u009dof their drug clinical trials on the Internet. They can no longer selectively choose what they want you to know. The <\/span><span style=\"font-size: 13.5pt; font-family: Tahoma\">posting will include a glossary for the lay people explaining technical terms to ensure that such information is not misleading or misunderstood.<\/span><\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\"><span style=\"font-size: 13.5pt; font-family: Tahoma\"><\/span><\/p>\n<p><span style=\"font-size: 13.5pt; font-family: Tahoma\"><\/span><\/span><span style=\"font-size: 13.5pt; font-family: Tahoma\"><\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\"><span style=\"font-size: 13.5pt; font-family: Wingdings\">\u00c3\u201a\u00c2\u00a7<\/span><span style=\"font-size: 7pt; font-family: 'Times New Roman'\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 <\/span><span style=\"font-size: 13.5pt; font-family: Tahoma\">If any drug maker submits false information on a clinical trial, the FDA will post a notice stating: \u00c3\u00a2\u00e2\u201a\u00ac\u00c5\u201c<\/span><span style=\"font-size: 13.5pt; font-family: Tahoma\">The entry for this clinical trial was found to be false or misleading and therefore not in compliance with the law.\u00c3\u00a2\u00e2\u201a\u00ac\u00c2\u009d<\/span><\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\">\u00c3\u201a\u00c2\u00a0<\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\"><span style=\"font-size: 13.5pt; font-family: Wingdings\">\u00c3\u201a\u00c2\u00a7<\/span><span style=\"font-size: 7pt; font-family: 'Times New Roman'\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 <\/span><span style=\"font-size: 13.5pt; font-family: Tahoma\">The FDA must now monitor drug advertisements and if they are false or misleading, can fine drug makers up to to\u00c3\u201a\u00c2\u00a0$10\u00c3\u201a\u00c2\u00a0million.<\/span><\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\">\u00c3\u201a\u00c2\u00a0<\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\"><span style=\"font-size: 13.5pt; color: black; font-family: Tahoma\">You can see that your\u00c3\u201a\u00c2\u00a0support of CCHR\u00c3\u201a\u00c2\u00a0is getting dynamic RESULTS. Please continue to support CCHR with your donations and your volunteer efforts.<\/span><\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in\">\u00c3\u201a\u00c2\u00a0<\/p>\n<p class=\"MsoNormal\" style=\"margin-left: 0.25in; text-indent: -0.25in; text-align: center\" align=\"center\"><strong><span style=\"font-size: 13.5pt; color: black; font-family: Tahoma\"><a href=\"http:\/\/www.cchr.org\/index.cfm\/6979\">Think psychiatrists don&#8217;t<br \/>\nknow their drugs<br \/>\ncause violence?<br \/>\nThink again.<\/a><\/span><\/strong>\n<\/p>\n<p class=\"MsoNormal\">\u00c3\u201a\u00c2\u00a0<\/p>\n<p><\/span><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Congress gave final approval Thursday, November 20, 2007 \u00c3\u201a\u00c2\u00a0to legislation designed to transform the Food and Drug Administration from a passive monitor to an active detective seeking out medications that have been approved for sale but turn out to be &hellip; <a href=\"https:\/\/www.cchrstl.org\/wordpress\/2007\/09\/30\/the-food-and-drug-administration-amendments-act-of-2007-hr-3580\/\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[2,3],"tags":[],"class_list":["post-27","post","type-post","status-publish","format-standard","hentry","category-big-muddy-river-newsletter","category-press-releases"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p6NMpC-r","jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/27","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/comments?post=27"}],"version-history":[{"count":0,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/27\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/media?parent=27"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/categories?post=27"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/tags?post=27"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}