{"id":58,"date":"2008-04-06T08:12:10","date_gmt":"2008-04-06T15:12:10","guid":{"rendered":"http:\/\/cchrstl.org\/wordpress\/?p=58"},"modified":"2024-07-14T05:43:53","modified_gmt":"2024-07-14T10:43:53","slug":"the-fda-issues-new-rules-on-drug-marketing","status":"publish","type":"post","link":"https:\/\/www.cchrstl.org\/wordpress\/2008\/04\/06\/the-fda-issues-new-rules-on-drug-marketing\/","title":{"rendered":"The FDA Issues New Rules on Drug Marketing"},"content":{"rendered":"<div align=\"center\">Your Comments are\u00c3\u201a\u00c2\u00a0Needed Now!<\/div>\n<p>\u00c3\u201a\u00c2\u00a0<\/p>\n<div align=\"left\"><font size=\"3\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 The FDA recently announced new rules on how drug companies can promote drugs to your doctor for purposes other than what they were approved for. You can probably think of your own examples, but what if your doctor was handed some new study showing that antidepressants were just great for treating the common cold.\u00c3\u201a\u00c2\u00a0While this example is admittedly farfetched, it isn&#8217;t out of the question.\u00c3\u201a\u00c2\u00a0This practice, known as off-label marketing, has been prohibited in many cases and for good reason.\u00c3\u201a\u00c2\u00a0Off-label marketing means that a company is promoting a drug for a different use or for a different population than it was intended for.\u00c3\u201a\u00c2\u00a0There could be all sorts of unknown risks.<\/font>\u00c3\u201a\u00c2\u00a0<\/p>\n<p><font size=\"3\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 While the use of drugs for unapproved purposes is certainly nothing new, allowing such marketing with little or no oversight is a move that puts us all at risk.\u00c3\u201a\u00c2\u00a0Luckily, these rules won&#8217;t go into effect immediately and are currently open for public comment.\u00c3\u201a\u00c2\u00a0So, the solution is simple:\u00c3\u201a\u00c2\u00a0Comment!\u00c3\u201a\u00c2\u00a0In fact, don&#8217;t just tell the agency what you think, send a copy of your comment to your Congressmen too.<\/font><\/p>\n<p><font size=\"3\">You can read the proposed rule here:<\/font><\/p>\n<p><a href=\"http:\/\/rs6.net\/tn.jsp?e=001V0DlmXXDLHZlZKfhBHk6N9_WOVP2JZZ_8lEKCrD0ZpOIRR2Du2cKSA764eGirFIGdjKC1dXkXahIuiZDzGqPi-yLwWUNxkF0kbymVUcMDculrXhAjpiPv-URxrHwdq72jEEqrLQqu2Y=\" target=\"_blank\" rel=\"noopener\"><font size=\"3\">www.fda.gov\/oc\/op\/goodreprint.html<\/font><\/a><font size=\"3\">.<\/font><\/p>\n<p><font size=\"3\">You can submit your comment here:<\/font><\/p>\n<p><a href=\"http:\/\/rs6.net\/tn.jsp?e=001V0DlmXXDLHZYuh-dQagh3qI4W2MSja2HPA5ip_jOvCQVBz4ZTKDxFeadqU0Kjs2NRTZAqqV9A6KzsxaeT2j-dqchcmoVMDI5-894O1bGxQVA6oZc2TS6OQEqHSnKcr1-IDv_1DXv1V_jBjWZP1uIcEWSkNnuIkYwYKjBu5uZFqQfkDnvoLen7BruOkJo-KIrk5HmkObwOMezBfFHj4UBTJ8XGNgZRdUO\" target=\"_blank\" rel=\"noopener\"><font size=\"3\">Docket Number FDA-2008-D-0053<\/font><\/a><\/p>\n<p><font size=\"3\">To find your federal legislators, go to <a href=\"http:\/\/www.congress.org\/\">www.congress.org<\/a> and enter your zip code.<\/font><\/p>\n<p><font size=\"3\">Here are a few points that might help you formulate your comments:<\/font><\/p>\n<p><font size=\"3\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 While the FDA wants to protect the off-label marketing of drugs, states and other federal agencies have gone after numerous drug companies accused of off-label marketing schemes.\u00c3\u201a\u00c2\u00a0 Here are a few examples:<br \/>\n<\/font><font size=\"3\">\u00c3\u201a\u00c2\u00a0 <\/font><\/p>\n<ul type=\"disc\">\n<li><font size=\"3\">2003, Pfizer settled with the US Department of Justice for $430 million related to its marketing of the anti-seizure drug Neurontin. <\/font><\/li>\n<li><font size=\"3\">2006, the Texas Attorney General&#8217;s office sued Janssen Pharmaceutical over allegations of illegal marketing practices related to the antipsychotic drug Risperdal. <\/font><\/li>\n<li><font size=\"3\">2008, drug maker Eli Lilly is reportedly in settlement negotiations with the US Department of Justice over its marketing of the antipsychotic drug Zyprexa.\u00c3\u201a\u00c2\u00a0 According to a recent article in the New York Times, Lilly could end up paying as much as $1 billion. <\/font><\/li>\n<li><font size=\"3\">Over 10 states have sued, accusing drug makers of off-label marketing.<\/font><\/li>\n<\/ul>\n<p><font size=\"3\">\u00c3\u201a\u00c2\u00a0 <\/font><\/p>\n<p><font size=\"3\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 This proposed rule change puts patients at risk and violates even the most basic concept of informed consent.\u00c3\u201a\u00c2\u00a0Does the FDA want you to have the benefit of the latest greatest wonder drugs?\u00c3\u201a\u00c2\u00a0Or is it really about protecting an industry?\u00c3\u201a\u00c2\u00a0The FDA&#8217;s rush to bring new drugs to the market has not resulted in better health for Americans:<br \/>\n<\/font><font size=\"3\">\u00c3\u201a\u00c2\u00a0 <\/font><\/p>\n<ul type=\"disc\">\n<li><font size=\"3\">In 2004, the FDA added black box warnings to antidepressant drugs used\u00c3\u201a\u00c2\u00a0in children.\u00c3\u201a\u00c2\u00a0 Reported cases of suicide and suicidal thoughts as well as hostility and homicidal behavior had existed for over a decade before the FDA finally took a serious look at the problem. <\/font><\/li>\n<li><font size=\"3\">In 2006, the FDA finally warned about aggression, heart complications and psychotic behavior associated with the drugs used to treat Attention Deficit Hyperactivity Disorder.\u00c3\u201a\u00c2\u00a0 This agency had been aware of potential heart risks and psychotic behavior associated with stimulant use for decades. <\/font><\/li>\n<li><font size=\"3\">The FDA has repeatedly come under fire for failing to adequately ensure drug safety.\u00c3\u201a\u00c2\u00a0 Most recently, the FDA admitted it had never inspected a Chinese manufacturing plant that could be the source of a drug ingredient suspected of causing over 350 allergic reactions. <\/font><\/li>\n<li><font size=\"3\">The FDA does not have an accurate and dependable system of capturing adverse reactions to drugs.\u00c3\u201a\u00c2\u00a0It is estimated that the FDA&#8217;s adverse event reporting system (MedWatch) only captures between 1% and 10% of adverse events.<\/font><\/li>\n<\/ul>\n<p><font size=\"3\">\u00c3\u201a\u00c2\u00a0 <\/font><\/p>\n<p><font size=\"3\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 Encouraging drug companies to expand their off-label marketing efforts without rigorous safety testing could expose patients to even greater dangers.<\/font><\/p>\n<p><font size=\"3\">\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 Take the time to submit your comments today.\u00c3\u201a\u00c2\u00a0If you need more information a simple internet search on the FDA and drug safety or off-label marketing should be able to provide more than enough information. You can also read\u00c3\u201a\u00c2\u00a0various CCHR publications on the dangers of psychiatric drugs at <\/font><a href=\"http:\/\/www.cchr.org\/psychiatric_drugs\/\">http:\/\/www.cchr.org\/psychiatric_drugs\/<\/a>.<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Your Comments are\u00c3\u201a\u00c2\u00a0Needed Now! \u00c3\u201a\u00c2\u00a0 \u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0\u00c3\u201a\u00c2\u00a0 The FDA recently announced new rules on how drug companies can promote drugs to your doctor for purposes other than what they were approved for. You can probably think of your own examples, but &hellip; <a href=\"https:\/\/www.cchrstl.org\/wordpress\/2008\/04\/06\/the-fda-issues-new-rules-on-drug-marketing\/\">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-58","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-W","jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/58","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=58"}],"version-history":[{"count":0,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/58\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/media?parent=58"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/categories?post=58"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/tags?post=58"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}