{"id":1016,"date":"2016-01-16T21:12:43","date_gmt":"2016-01-17T02:12:43","guid":{"rendered":"http:\/\/www.cchrstl.org\/wordpress\/?p=1016"},"modified":"2024-07-14T05:41:01","modified_gmt":"2024-07-14T10:41:01","slug":"s-2388-reciprocity-ensures-streamlined-use-of-lifesaving-treatments-act-of-2015","status":"publish","type":"post","link":"https:\/\/www.cchrstl.org\/wordpress\/2016\/01\/16\/s-2388-reciprocity-ensures-streamlined-use-of-lifesaving-treatments-act-of-2015\/","title":{"rendered":"S.2388 Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015"},"content":{"rendered":"<p><a href=\"https:\/\/www.congress.gov\/bill\/114th-congress\/senate-bill\/2388\/\">This bill, S.2388<\/a>, introduced in the U.S. Senate by Senators Ted Cruz (R-TX) and\u00a0Mike Lee (R-UT)\u00a0on 12\/10\/2015, has been referred to the Committee on Health, Education, Labor, and Pensions (HELP).<\/p>\n<p>Its stated purpose is &#8220;To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes.&#8221;<\/p>\n<p>Essentially what this Act would provide is that if a\u00a0drug, biological product, or device is approved for use\u00a0in another country, then the\u00a0U.S. Food and Drug Administration (FDA)\u00a0would approve it for use in the United States without it having to go through the entire FDA approval process.<\/p>\n<p>While we applaud the\u00a0Senators for\u00a0desiring to reduce the inherent bureaucracy of the FDA, we cannot help but notice that this would open the door for marketing various harmful psychiatric drugs and devices without satisfying the usual FDA requirements for safety and effectiveness.<\/p>\n<p>The Act also authorizes an outreach campaign to encourage the sponsors of\u00a0such products that are potentially eligible for reciprocal marketing approval to request such approval.<\/p>\n<p>We think this Act deserves to be amended to explicitly exclude psychiatric drugs, and devices such as transcranial magnetic stimulation,\u00a0vagus nerve stimulation, deep brain stimulation, or any other electric shock or magnetic wave device designed to interfere with the brain.<\/p>\n<p>Please <a href=\"https:\/\/www.congress.gov\/members\">contact your U.S. Senator<\/a> and the <a href=\"https:\/\/www.congress.gov\/committee\/senate-health-education-labor-and-pensions\/sshr00\">members of HELP<\/a> to express your viewpoint regarding S.2388.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>This bill, S.2388, introduced in the U.S. Senate by Senators Ted Cruz (R-TX) and\u00a0Mike Lee (R-UT)\u00a0on 12\/10\/2015, has been referred to the Committee on Health, Education, Labor, and Pensions (HELP). Its stated purpose is &#8220;To amend the Federal Food, Drug, &hellip; <a href=\"https:\/\/www.cchrstl.org\/wordpress\/2016\/01\/16\/s-2388-reciprocity-ensures-streamlined-use-of-lifesaving-treatments-act-of-2015\/\">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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[2,3],"tags":[108,5],"class_list":["post-1016","post","type-post","status-publish","format-standard","hentry","category-big-muddy-river-newsletter","category-press-releases","tag-fda","tag-takeaction"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p6NMpC-go","jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/1016","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=1016"}],"version-history":[{"count":0,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/posts\/1016\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/media?parent=1016"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/categories?post=1016"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cchrstl.org\/wordpress\/wp-json\/wp\/v2\/tags?post=1016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}