{"id":21212,"date":"2013-11-08T05:00:00","date_gmt":"2013-11-08T05:00:00","guid":{"rendered":"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/"},"modified":"2013-11-08T05:00:00","modified_gmt":"2013-11-08T05:00:00","slug":"fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety","status":"publish","type":"news","link":"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/","title":{"rendered":"FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety"},"content":{"rendered":"<p>Nov. 8, 2013<\/p>\n<p><span style=\"font-size:14px;\"><strong>FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety<\/strong><\/span><\/p>\n<p><span style=\"font-size: 12px;\"><em>Statement of <\/em><\/span><span style=\"font-size:12px;\"><em>Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen\u2019s Health Research Group and <\/em><\/span><span style=\"font-size:12px;\"><em>Allison Zieve, Director, Public Citizen Litigation Group<\/em><\/span><\/p>\n<p>We are extremely pleased that the Food and Drug Administration (FDA) today issued a proposed rule to revise FDA regulations about generic drug labeling. When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety. The proposed rule will allow generic drug manufacturers to \u201cchange the labeling of an approved drug or biologic product to reflect certain types of newly-acquired safety-related\u00a0information in advance of FDA\u2019s review of the changes.\u201d When finalized after public comments, the rule will provide added protection to the tens of millions of people who regularly use generic drugs.<\/p>\n<p>Many potential hazards are not discovered until years after drugs have been on the market, <a href=\"https:\/\/www.citizen.org\/our-work\/health-and-safety\/articles\/generic-drug-labeling-report-serious-warnings-added-approved\">as documented in a recent Public Citizen report<\/a>, yet, currently, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk. The new rule should remedy this public health problem.<\/p>\n<p>Under current FDA regulations, generic manufacturers cannot update their products\u2019 labeling, even if they become aware of a potential risk not stated in the labeling. In contrast, brand-name drug manufacturers can update warnings and precautions before getting FDA approval.<\/p>\n<p>In August\u00a02011, <a href=\"https:\/\/www.citizen.org\/pressreleases\/generic-drug-manufacturers-should-be-able-warn-products-risks-public-citizen-tells-fda\">Public Citizen submitted a citizen petition to the FDA<\/a> asking it to revise its labeling rules to fill the safety gap. While formally the FDA stated in a letter that it was granting our petition in part, the agency has approved the critical issues addressed in our petition.<\/p>\n<p>The proposed rule creates parity between brand-name drug manufacturers and generic drug manufacturers with respect to revising drug labeling to provide information about newly discovered risks. It would address requirements that all manufacturers of the same drug submit conforming labeling revisions after the FDA has approved a revision by one manufacturer of that drug.<\/p>\n<p style=\"text-align: center;\">###<\/p>\n ","protected":false},"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"_links_to":"","_links_to_target":""},"class_list":["post-21212","news","type-news","status-publish","hentry","tax_news-press"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety - Public Citizen<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety - Public Citizen\" \/>\n<meta property=\"og:description\" content=\"Nov. 8, 2013 FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen\u2019s Health Research Group and Allison Zieve, Director, Public Citizen Litigation Group\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/\" \/>\n<meta property=\"og:site_name\" content=\"Public Citizen\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/publiccitizen\/\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.citizen.org\/wp-content\/uploads\/public_citizen_shared_link.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"628\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@Public_Citizen\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/\",\"url\":\"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/\",\"name\":\"FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety - Public Citizen\",\"isPartOf\":{\"@id\":\"https:\/\/www.citizen.org\/#website\"},\"datePublished\":\"2013-11-08T05:00:00+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.citizen.org\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.citizen.org\/#website\",\"url\":\"https:\/\/www.citizen.org\/\",\"name\":\"Public Citizen\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.citizen.org\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety - Public Citizen","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":"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/","og_locale":"en_US","og_type":"article","og_title":"FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety - Public Citizen","og_description":"Nov. 8, 2013 FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety Statement of Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen\u2019s Health Research Group and Allison Zieve, Director, Public Citizen Litigation Group","og_url":"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/","og_site_name":"Public Citizen","article_publisher":"https:\/\/www.facebook.com\/publiccitizen\/","og_image":[{"width":1200,"height":628,"url":"https:\/\/www.citizen.org\/wp-content\/uploads\/public_citizen_shared_link.jpg","type":"image\/jpeg"}],"twitter_card":"summary_large_image","twitter_site":"@Public_Citizen","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/","url":"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/","name":"FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety - Public Citizen","isPartOf":{"@id":"https:\/\/www.citizen.org\/#website"},"datePublished":"2013-11-08T05:00:00+00:00","breadcrumb":{"@id":"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.citizen.org\/news\/fda-grants-public-citizen-petition-issues-proposed-rule-on-generic-drug-safety\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.citizen.org\/"},{"@type":"ListItem","position":2,"name":"FDA Grants Public Citizen Petition, Issues Proposed Rule on Generic Drug Safety"}]},{"@type":"WebSite","@id":"https:\/\/www.citizen.org\/#website","url":"https:\/\/www.citizen.org\/","name":"Public Citizen","description":"","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.citizen.org\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.citizen.org\/wp-json\/wp\/v2\/news\/21212","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.citizen.org\/wp-json\/wp\/v2\/news"}],"about":[{"href":"https:\/\/www.citizen.org\/wp-json\/wp\/v2\/types\/news"}],"version-history":[{"count":0,"href":"https:\/\/www.citizen.org\/wp-json\/wp\/v2\/news\/21212\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.citizen.org\/wp-json\/wp\/v2\/media?parent=21212"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}