{"id":5198,"date":"2008-04-03T14:13:31","date_gmt":"2008-04-03T18:13:31","guid":{"rendered":"\/gazette\/?p=5198"},"modified":"2017-12-15T04:35:02","modified_gmt":"2017-12-15T09:35:02","slug":"fda-deadlines-may-compromise-drug-safety-by-rushing-approvals","status":"publish","type":"post","link":"https:\/\/news.harvard.edu\/gazette\/story\/2008\/04\/fda-deadlines-may-compromise-drug-safety-by-rushing-approvals\/","title":{"rendered":"FDA deadlines may compromise drug safety by rushing approvals"},"content":{"rendered":"<header\n\tclass=\"wp-block-harvard-gazette-article-header alignfull article-header is-style-full-width-text-below centered-image\"\n\tstyle=\" \"\n>\n\t<figure class=\"wp-block-image\"><img decoding=\"async\" alt=\"\" height=\"\" loading=\"eager\" src=\"\" width=\"\"\/><figcaption class=\"wp-element-caption\"><p class=\"wp-element-caption--credit\">Staff file photo Jon Chase\/Harvard News Office<\/p><\/figcaption><\/figure>\n\n\t<div class=\"article-header__content\">\n\t\t\t<a\n\t\t\tclass=\"article-header__category\"\n\t\t\thref=\"https:\/\/news.harvard.edu\/gazette\/section\/health\/\"\n\t\t>\n\t\t\tHealth\t\t<\/a>\n\t\t\n\t\t<h1 class=\"article-header__title wp-block-heading \">\n\t\tFDA deadlines may compromise drug safety by rushing approvals\t<\/h1>\n\n\t\n\t\t\t<\/div>\n\t\t\n\t<div class=\"article-header__meta\">\n\t\t<div class=\"wp-block-post-author\">\n\t\t\t<address class=\"wp-block-post-author__content\">\n\t\t\t\t\t<p class=\"author wp-block-post-author__name\">\n\t\tAmy Lavoie\t<\/p>\n\t\t\t<p class=\"wp-block-post-author__byline\">\n\t\t\tFAS Communications\t\t<\/p>\n\t\t\t\t\t<\/address>\n\t\t<\/div>\n\n\t\t<time class=\"article-header__date\" datetime=\"2008-04-03\">\n\t\t\tApril 3, 2008\t\t<\/time>\n\n\t\t<span class=\"article-header__reading-time\">\n\t\t\t4 min read\t\t<\/span>\n\t<\/div>\n\n\t\n\t\n<\/header>\n\n\n\n<div class=\"wp-block-group alignwide has-global-padding is-content-justification-center is-layout-constrained wp-block-group-is-layout-constrained\">\n\n\n\t\t<p style=\"font-size:14px;\">Many medications are approved by the U.S. Food and Drug Administration (FDA) on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in Harvard&#8217;s Faculty of Arts and Sciences. The research was published in the March 27 issue of the New England Journal of Medicine.<\/p>\n<p style=\"font-size:14px;\">Carpenter\u2019s co-authors were Jerry Avorn, professor of medicine at Harvard Medical School (HMS) and chief of the division of pharmacoepidemiology at Brigham and Women\u2019s Hospital, and Evan James Zucker, a student at HMS.<\/p>\n<p style=\"font-size:14px;\">\u201cWe found that while these deadlines speed up the approval process, many drugs are approved right up against the deadline, which might lead to unintended consequences with regard to drug safety,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">\u201cThis suggests that drug safety might improve under an FDA approval protocol that is more flexible and less driven by deadline pressures and more by stable growth in FDA resources.\u201d<\/p>\n<p style=\"font-size:14px;\">The deadlines imposed on the FDA\u2019s drug-approval process were first enacted as part of the Prescription Drug User Fee Act (PDUFA) of 1992, which mandated that the FDA must act on 90 percent of all drug candidates within 12 months of submission or face funding cuts. The timeline was tightened to 10 months as part of the 1997 Food and Drug Administration Modernization Act and renewed by Congress in 2002 as part of bioterrorism legislation (and renewed again in 2007).<\/p>\n<p style=\"font-size:14px;\">Some observers have suggested that these deadlines lead to the rushed approval of medications, a theory Carpenter tested by examining data on the timing of FDA approvals dating back to 1950. He found that the enactment of PDUFA in 1992 appeared to introduce a temporal discontinuity into FDA review cycles, with disproportionate approvals coming in the two months immediately before deadlines. Compared with drugs approved at a more measured pace in the months following the deadline, those approved right before the review clock expired were far more likely to require later regulatory intervention.<\/p>\n<p style=\"font-size:14px;\">\u201cDrugs rushed to approval just before the deadline are two to three times more likely to eventually be pulled off shelves due to safety concerns, two to seven times more likely to receive added label warnings known as \u2018black box revisions,\u2019 twice as likely to experience changes in manufacture, and two to seven times more likely to be voluntarily discontinued by manufacturers due to weak clinical demand,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">In previous work, Carpenter developed a mathematical model to understand how government agencies \u201clearn\u201d and how deadlines affect organizational behavior. This model predicts the pattern of outcomes described in the New England Journal study.<\/p>\n<p style=\"font-size:14px;\">Fifty years ago, the FDA approved most new medications within a few months of receiving applications from manufacturers. Over time, the process slowed as new review protocols were added in the wake of pharmaceutical missteps such as thalidomide, which led to the births of thousands of deformed babies in the late 1950s and early 1960s.<\/p>\n<p style=\"font-size:14px;\">\u201cBecause of similarly high-profile regulatory mistakes in recent years, we will likely see greater congressional scrutiny in coming decades as these FDA deadlines come up for renewal every five years,\u201d Carpenter says. \u201cWhile we are not arguing that these deadlines should be abandoned, our research indicates that mechanisms other than strict deadlines may better balance the need for expeditious yet rigorous drug approval.\u201d<\/p>\n<p style=\"font-size:14px;\">The research was funded by the Robert Wood Johnson Foundation, the National Science Foundation, Harvard\u2019s Center for American Political Studies, and the Institute for Quantitative Social Science at Harvard.<\/p>\n\n\n<\/div>\n\n\t\t","protected":false},"excerpt":{"rendered":"<p>Many medications are approved by the U.S. Food and Drug Administration (FDA) on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in Harvard\u2019s Faculty of Arts and Sciences. The research was published in the March 27 issue of the New England Journal of Medicine.<\/p>\n","protected":false},"author":105622744,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"gz_ga_pageviews":13,"gz_ga_lastupdated":"2021-11-07 20:22","document_color_palette":"crimson","author":"Amy Lavoie","affiliation":"FAS Communications","_category_override":"","_yoast_wpseo_primary_category":"","_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[39644],"tags":[6797,16519,17054,23445,29171,30642],"gazette-formats":[],"series":[],"class_list":["post-5198","post","type-post","status-publish","format-standard","hentry","category-health","tag-bwh","tag-health","tag-hms","tag-medicine","tag-research","tag-science"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.0 (Yoast SEO v27.1.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FDA deadlines may compromise drug safety by rushing approvals &#8212; Harvard Gazette<\/title>\n<meta name=\"description\" content=\"Many medications are approved by the U.S. Food and Drug Administration (FDA) on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in Harvard\u2019s Faculty of Arts and Sciences. The research was published in the March 27 issue of the New England Journal of Medicine.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/news.harvard.edu\/gazette\/story\/2008\/04\/fda-deadlines-may-compromise-drug-safety-by-rushing-approvals\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA deadlines may compromise drug safety by rushing approvals &#8212; Harvard Gazette\" \/>\n<meta property=\"og:description\" content=\"Many medications are approved by the U.S. Food and Drug Administration (FDA) on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in Harvard\u2019s Faculty of Arts and Sciences. The research was published in the March 27 issue of the New England Journal of Medicine.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/news.harvard.edu\/gazette\/story\/2008\/04\/fda-deadlines-may-compromise-drug-safety-by-rushing-approvals\/\" \/>\n<meta property=\"og:site_name\" content=\"Harvard Gazette\" \/>\n<meta property=\"article:published_time\" content=\"2008-04-03T18:13:31+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2017-12-15T09:35:02+00:00\" \/>\n<meta name=\"author\" content=\"harvardgazette\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/news.harvard.edu\/gazette\/story\/2008\/04\/fda-deadlines-may-compromise-drug-safety-by-rushing-approvals\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/news.harvard.edu\/gazette\/story\/2008\/04\/fda-deadlines-may-compromise-drug-safety-by-rushing-approvals\/\"},\"author\":{\"name\":\"harvardgazette\",\"@id\":\"https:\/\/news.harvard.edu\/gazette\/#\/schema\/person\/78d028cf624923e92682268709ffbc4b\"},\"headline\":\"FDA deadlines may compromise drug safety by rushing approvals\",\"datePublished\":\"2008-04-03T18:13:31+00:00\",\"dateModified\":\"2017-12-15T09:35:02+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/news.harvard.edu\/gazette\/story\/2008\/04\/fda-deadlines-may-compromise-drug-safety-by-rushing-approvals\/\"},\"wordCount\":629,\"publisher\":{\"@id\":\"https:\/\/news.harvard.edu\/gazette\/#organization\"},\"keywords\":[\"BWH\",\"Health\",\"HMS\",\"Medicine\",\"Research\",\"Science\"],\"articleSection\":[\"Health\"],\"inLanguage\":\"en-US\",\"copyrightYear\":\"2008\",\"copyrightHolder\":{\"@id\":\"https:\/\/news.harvard.edu\/gazette\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/news.harvard.edu\/gazette\/story\/2008\/04\/fda-deadlines-may-compromise-drug-safety-by-rushing-approvals\/\",\"url\":\"https:\/\/news.harvard.edu\/gazette\/story\/2008\/04\/fda-deadlines-may-compromise-drug-safety-by-rushing-approvals\/\",\"name\":\"FDA deadlines may compromise drug safety by rushing approvals &#8212; Harvard Gazette\",\"isPartOf\":{\"@id\":\"https:\/\/news.harvard.edu\/gazette\/#website\"},\"datePublished\":\"2008-04-03T18:13:31+00:00\",\"dateModified\":\"2017-12-15T09:35:02+00:00\",\"description\":\"Many medications are approved by the U.S. Food and Drug Administration (FDA) on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. 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wp-block-post-author__name\">\n\t\tAmy Lavoie\t<\/p>\n\t\t\t<p class=\"wp-block-post-author__byline\">\n\t\t\tFAS Communications\t\t<\/p>\n\t\t\t\t\t<\/address>\n\t\t<\/div>\n\n\t\t<time class=\"article-header__date\" datetime=\"2008-04-03\">\n\t\t\tApril 3, 2008\t\t<\/time>\n\n\t\t<span class=\"article-header__reading-time\">\n\t\t\t4 min read\t\t<\/span>\n\t<\/div>\n\n\t\n\t\n<\/header>\n"},"2":{"blockName":"core\/group","attrs":{"templateLock":false,"metadata":{"name":"Article content"},"align":"wide","layout":{"type":"constrained","justifyContent":"center"},"tagName":"div","lock":[],"className":"","style":[],"backgroundColor":"","textColor":"","gradient":"","fontSize":"","fontFamily":"","borderColor":"","ariaLabel":"","anchor":""},"innerBlocks":[{"blockName":"core\/freeform","attrs":{"content":"","lock":[],"metadata":[]},"innerBlocks":[],"innerHTML":"\n\t\t<p style=\"font-size:14px;\">Many medications are approved by the U.S. Food and Drug Administration (FDA) on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in Harvard's Faculty of Arts and Sciences. The research was published in the March 27 issue of the New England Journal of Medicine.<\/p>\n<p style=\"font-size:14px;\">Carpenter\u2019s co-authors were Jerry Avorn, professor of medicine at Harvard Medical School (HMS) and chief of the division of pharmacoepidemiology at Brigham and Women\u2019s Hospital, and Evan James Zucker, a student at HMS.<\/p>\n<p style=\"font-size:14px;\">\u201cWe found that while these deadlines speed up the approval process, many drugs are approved right up against the deadline, which might lead to unintended consequences with regard to drug safety,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">\u201cThis suggests that drug safety might improve under an FDA approval protocol that is more flexible and less driven by deadline pressures and more by stable growth in FDA resources.\u201d<\/p>\n<p style=\"font-size:14px;\">The deadlines imposed on the FDA\u2019s drug-approval process were first enacted as part of the Prescription Drug User Fee Act (PDUFA) of 1992, which mandated that the FDA must act on 90 percent of all drug candidates within 12 months of submission or face funding cuts. The timeline was tightened to 10 months as part of the 1997 Food and Drug Administration Modernization Act and renewed by Congress in 2002 as part of bioterrorism legislation (and renewed again in 2007).<\/p>\n<p style=\"font-size:14px;\">Some observers have suggested that these deadlines lead to the rushed approval of medications, a theory Carpenter tested by examining data on the timing of FDA approvals dating back to 1950. He found that the enactment of PDUFA in 1992 appeared to introduce a temporal discontinuity into FDA review cycles, with disproportionate approvals coming in the two months immediately before deadlines. Compared with drugs approved at a more measured pace in the months following the deadline, those approved right before the review clock expired were far more likely to require later regulatory intervention.<\/p>\n<p style=\"font-size:14px;\">\u201cDrugs rushed to approval just before the deadline are two to three times more likely to eventually be pulled off shelves due to safety concerns, two to seven times more likely to receive added label warnings known as \u2018black box revisions,\u2019 twice as likely to experience changes in manufacture, and two to seven times more likely to be voluntarily discontinued by manufacturers due to weak clinical demand,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">In previous work, Carpenter developed a mathematical model to understand how government agencies \u201clearn\u201d and how deadlines affect organizational behavior. This model predicts the pattern of outcomes described in the New England Journal study.<\/p>\n<p style=\"font-size:14px;\">Fifty years ago, the FDA approved most new medications within a few months of receiving applications from manufacturers. Over time, the process slowed as new review protocols were added in the wake of pharmaceutical missteps such as thalidomide, which led to the births of thousands of deformed babies in the late 1950s and early 1960s.<\/p>\n<p style=\"font-size:14px;\">\u201cBecause of similarly high-profile regulatory mistakes in recent years, we will likely see greater congressional scrutiny in coming decades as these FDA deadlines come up for renewal every five years,\u201d Carpenter says. \u201cWhile we are not arguing that these deadlines should be abandoned, our research indicates that mechanisms other than strict deadlines may better balance the need for expeditious yet rigorous drug approval.\u201d<\/p>\n<p style=\"font-size:14px;\">The research was funded by the Robert Wood Johnson Foundation, the National Science Foundation, Harvard\u2019s Center for American Political Studies, and the Institute for Quantitative Social Science at Harvard.<\/p>\n","innerContent":["\n\t\t<p style=\"font-size:14px;\">Many medications are approved by the U.S. Food and Drug Administration (FDA) on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in Harvard's Faculty of Arts and Sciences. The research was published in the March 27 issue of the New England Journal of Medicine.<\/p>\n<p style=\"font-size:14px;\">Carpenter\u2019s co-authors were Jerry Avorn, professor of medicine at Harvard Medical School (HMS) and chief of the division of pharmacoepidemiology at Brigham and Women\u2019s Hospital, and Evan James Zucker, a student at HMS.<\/p>\n<p style=\"font-size:14px;\">\u201cWe found that while these deadlines speed up the approval process, many drugs are approved right up against the deadline, which might lead to unintended consequences with regard to drug safety,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">\u201cThis suggests that drug safety might improve under an FDA approval protocol that is more flexible and less driven by deadline pressures and more by stable growth in FDA resources.\u201d<\/p>\n<p style=\"font-size:14px;\">The deadlines imposed on the FDA\u2019s drug-approval process were first enacted as part of the Prescription Drug User Fee Act (PDUFA) of 1992, which mandated that the FDA must act on 90 percent of all drug candidates within 12 months of submission or face funding cuts. The timeline was tightened to 10 months as part of the 1997 Food and Drug Administration Modernization Act and renewed by Congress in 2002 as part of bioterrorism legislation (and renewed again in 2007).<\/p>\n<p style=\"font-size:14px;\">Some observers have suggested that these deadlines lead to the rushed approval of medications, a theory Carpenter tested by examining data on the timing of FDA approvals dating back to 1950. He found that the enactment of PDUFA in 1992 appeared to introduce a temporal discontinuity into FDA review cycles, with disproportionate approvals coming in the two months immediately before deadlines. Compared with drugs approved at a more measured pace in the months following the deadline, those approved right before the review clock expired were far more likely to require later regulatory intervention.<\/p>\n<p style=\"font-size:14px;\">\u201cDrugs rushed to approval just before the deadline are two to three times more likely to eventually be pulled off shelves due to safety concerns, two to seven times more likely to receive added label warnings known as \u2018black box revisions,\u2019 twice as likely to experience changes in manufacture, and two to seven times more likely to be voluntarily discontinued by manufacturers due to weak clinical demand,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">In previous work, Carpenter developed a mathematical model to understand how government agencies \u201clearn\u201d and how deadlines affect organizational behavior. This model predicts the pattern of outcomes described in the New England Journal study.<\/p>\n<p style=\"font-size:14px;\">Fifty years ago, the FDA approved most new medications within a few months of receiving applications from manufacturers. Over time, the process slowed as new review protocols were added in the wake of pharmaceutical missteps such as thalidomide, which led to the births of thousands of deformed babies in the late 1950s and early 1960s.<\/p>\n<p style=\"font-size:14px;\">\u201cBecause of similarly high-profile regulatory mistakes in recent years, we will likely see greater congressional scrutiny in coming decades as these FDA deadlines come up for renewal every five years,\u201d Carpenter says. \u201cWhile we are not arguing that these deadlines should be abandoned, our research indicates that mechanisms other than strict deadlines may better balance the need for expeditious yet rigorous drug approval.\u201d<\/p>\n<p style=\"font-size:14px;\">The research was funded by the Robert Wood Johnson Foundation, the National Science Foundation, Harvard\u2019s Center for American Political Studies, and the Institute for Quantitative Social Science at Harvard.<\/p>\n"],"rendered":"\n\t\t<p style=\"font-size:14px;\">Many medications are approved by the U.S. Food and Drug Administration (FDA) on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in Harvard's Faculty of Arts and Sciences. The research was published in the March 27 issue of the New England Journal of Medicine.<\/p>\n<p style=\"font-size:14px;\">Carpenter\u2019s co-authors were Jerry Avorn, professor of medicine at Harvard Medical School (HMS) and chief of the division of pharmacoepidemiology at Brigham and Women\u2019s Hospital, and Evan James Zucker, a student at HMS.<\/p>\n<p style=\"font-size:14px;\">\u201cWe found that while these deadlines speed up the approval process, many drugs are approved right up against the deadline, which might lead to unintended consequences with regard to drug safety,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">\u201cThis suggests that drug safety might improve under an FDA approval protocol that is more flexible and less driven by deadline pressures and more by stable growth in FDA resources.\u201d<\/p>\n<p style=\"font-size:14px;\">The deadlines imposed on the FDA\u2019s drug-approval process were first enacted as part of the Prescription Drug User Fee Act (PDUFA) of 1992, which mandated that the FDA must act on 90 percent of all drug candidates within 12 months of submission or face funding cuts. The timeline was tightened to 10 months as part of the 1997 Food and Drug Administration Modernization Act and renewed by Congress in 2002 as part of bioterrorism legislation (and renewed again in 2007).<\/p>\n<p style=\"font-size:14px;\">Some observers have suggested that these deadlines lead to the rushed approval of medications, a theory Carpenter tested by examining data on the timing of FDA approvals dating back to 1950. He found that the enactment of PDUFA in 1992 appeared to introduce a temporal discontinuity into FDA review cycles, with disproportionate approvals coming in the two months immediately before deadlines. Compared with drugs approved at a more measured pace in the months following the deadline, those approved right before the review clock expired were far more likely to require later regulatory intervention.<\/p>\n<p style=\"font-size:14px;\">\u201cDrugs rushed to approval just before the deadline are two to three times more likely to eventually be pulled off shelves due to safety concerns, two to seven times more likely to receive added label warnings known as \u2018black box revisions,\u2019 twice as likely to experience changes in manufacture, and two to seven times more likely to be voluntarily discontinued by manufacturers due to weak clinical demand,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">In previous work, Carpenter developed a mathematical model to understand how government agencies \u201clearn\u201d and how deadlines affect organizational behavior. This model predicts the pattern of outcomes described in the New England Journal study.<\/p>\n<p style=\"font-size:14px;\">Fifty years ago, the FDA approved most new medications within a few months of receiving applications from manufacturers. Over time, the process slowed as new review protocols were added in the wake of pharmaceutical missteps such as thalidomide, which led to the births of thousands of deformed babies in the late 1950s and early 1960s.<\/p>\n<p style=\"font-size:14px;\">\u201cBecause of similarly high-profile regulatory mistakes in recent years, we will likely see greater congressional scrutiny in coming decades as these FDA deadlines come up for renewal every five years,\u201d Carpenter says. \u201cWhile we are not arguing that these deadlines should be abandoned, our research indicates that mechanisms other than strict deadlines may better balance the need for expeditious yet rigorous drug approval.\u201d<\/p>\n<p style=\"font-size:14px;\">The research was funded by the Robert Wood Johnson Foundation, the National Science Foundation, Harvard\u2019s Center for American Political Studies, and the Institute for Quantitative Social Science at Harvard.<\/p>\n"}],"innerHTML":"\n<div class=\"wp-block-group alignwide\">\n\n\n\n<\/div>\n","innerContent":["\n<div class=\"wp-block-group alignwide\">\n\n","\n\n<\/div>\n"],"rendered":"\n<div class=\"wp-block-group alignwide has-global-padding is-content-justification-center is-layout-constrained wp-block-group-is-layout-constrained\">\n\n\n\t\t<p style=\"font-size:14px;\">Many medications are approved by the U.S. Food and Drug Administration (FDA) on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in Harvard's Faculty of Arts and Sciences. The research was published in the March 27 issue of the New England Journal of Medicine.<\/p>\n<p style=\"font-size:14px;\">Carpenter\u2019s co-authors were Jerry Avorn, professor of medicine at Harvard Medical School (HMS) and chief of the division of pharmacoepidemiology at Brigham and Women\u2019s Hospital, and Evan James Zucker, a student at HMS.<\/p>\n<p style=\"font-size:14px;\">\u201cWe found that while these deadlines speed up the approval process, many drugs are approved right up against the deadline, which might lead to unintended consequences with regard to drug safety,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">\u201cThis suggests that drug safety might improve under an FDA approval protocol that is more flexible and less driven by deadline pressures and more by stable growth in FDA resources.\u201d<\/p>\n<p style=\"font-size:14px;\">The deadlines imposed on the FDA\u2019s drug-approval process were first enacted as part of the Prescription Drug User Fee Act (PDUFA) of 1992, which mandated that the FDA must act on 90 percent of all drug candidates within 12 months of submission or face funding cuts. The timeline was tightened to 10 months as part of the 1997 Food and Drug Administration Modernization Act and renewed by Congress in 2002 as part of bioterrorism legislation (and renewed again in 2007).<\/p>\n<p style=\"font-size:14px;\">Some observers have suggested that these deadlines lead to the rushed approval of medications, a theory Carpenter tested by examining data on the timing of FDA approvals dating back to 1950. He found that the enactment of PDUFA in 1992 appeared to introduce a temporal discontinuity into FDA review cycles, with disproportionate approvals coming in the two months immediately before deadlines. Compared with drugs approved at a more measured pace in the months following the deadline, those approved right before the review clock expired were far more likely to require later regulatory intervention.<\/p>\n<p style=\"font-size:14px;\">\u201cDrugs rushed to approval just before the deadline are two to three times more likely to eventually be pulled off shelves due to safety concerns, two to seven times more likely to receive added label warnings known as \u2018black box revisions,\u2019 twice as likely to experience changes in manufacture, and two to seven times more likely to be voluntarily discontinued by manufacturers due to weak clinical demand,\u201d says Carpenter.<\/p>\n<p style=\"font-size:14px;\">In previous work, Carpenter developed a mathematical model to understand how government agencies \u201clearn\u201d and how deadlines affect organizational behavior. This model predicts the pattern of outcomes described in the New England Journal study.<\/p>\n<p style=\"font-size:14px;\">Fifty years ago, the FDA approved most new medications within a few months of receiving applications from manufacturers. Over time, the process slowed as new review protocols were added in the wake of pharmaceutical missteps such as thalidomide, which led to the births of thousands of deformed babies in the late 1950s and early 1960s.<\/p>\n<p style=\"font-size:14px;\">\u201cBecause of similarly high-profile regulatory mistakes in recent years, we will likely see greater congressional scrutiny in coming decades as these FDA deadlines come up for renewal every five years,\u201d Carpenter says. \u201cWhile we are not arguing that these deadlines should be abandoned, our research indicates that mechanisms other than strict deadlines may better balance the need for expeditious yet rigorous drug approval.\u201d<\/p>\n<p style=\"font-size:14px;\">The research was funded by the Robert Wood Johnson Foundation, the National Science Foundation, Harvard\u2019s Center for American Political Studies, and the Institute for Quantitative Social Science at Harvard.<\/p>\n\n\n<\/div>\n"}},"jetpack-related-posts":[{"id":364051,"url":"https:\/\/news.harvard.edu\/gazette\/story\/2023\/09\/why-are-ineffective-oral-decongestants-still-on-store-shelves\/","url_meta":{"origin":5198,"position":0},"title":"Why are ineffective oral decongestants still on store shelves?","author":"harvardgazette","date":"September 20, 2023","format":false,"excerpt":"Drug regulation expert explains how the problem was discovered, next steps for FDA, and the questions it raises about other products, supplements.","rel":"","context":"In &quot;Health&quot;","block_context":{"text":"Health","link":"https:\/\/news.harvard.edu\/gazette\/section\/health\/"},"img":{"alt_text":"Sudafed and other common nasal decongestants.","src":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2023\/09\/Decongestant.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2023\/09\/Decongestant.jpg?resize=350%2C200 1x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2023\/09\/Decongestant.jpg?resize=525%2C300 1.5x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2023\/09\/Decongestant.jpg?resize=700%2C400 2x"},"classes":[]},{"id":126590,"url":"https:\/\/news.harvard.edu\/gazette\/story\/2012\/12\/problem-with-generic-meds\/","url_meta":{"origin":5198,"position":1},"title":"Problem with generic meds","author":"harvardgazette","date":"December 31, 2012","format":false,"excerpt":"Researchers from Harvard-affiliated Brigham and Women\u2019s Hospital have found that some patients who receive generic drugs that vary in their color are over 50 percent more likely to stop taking the drug, leading to potentially important and potentially adverse clinical effects.","rel":"","context":"In &quot;Health&quot;","block_context":{"text":"Health","link":"https:\/\/news.harvard.edu\/gazette\/section\/health\/"},"img":{"alt_text":"","src":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2012\/12\/greene-kesselheinejm-trade-dress1-2_blacksides_605.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2012\/12\/greene-kesselheinejm-trade-dress1-2_blacksides_605.jpg?resize=350%2C200 1x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2012\/12\/greene-kesselheinejm-trade-dress1-2_blacksides_605.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":307124,"url":"https:\/\/news.harvard.edu\/gazette\/story\/2020\/06\/darpa-taps-wyss-technology-to-id-drugs-for-covid-19-treatment\/","url_meta":{"origin":5198,"position":2},"title":"Wyss Institute to accelerate drug testing for COVID treatment","author":"harvardgazette","date":"June 16, 2020","format":false,"excerpt":"With a $16 million agreement from DARPA, Harvard\u2019s Wyss Institute will use its technology to identify and test already FDA-approved drugs that may prevent or treat COVID-19 infection.","rel":"","context":"In &quot;Science &amp; Tech&quot;","block_context":{"text":"Science &amp; Tech","link":"https:\/\/news.harvard.edu\/gazette\/section\/science-technology\/"},"img":{"alt_text":"Amir Bein checks a batch of human organ chips in the lab.","src":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2020\/06\/OrganChipTeam_AmirBeincheckingchips_H_2500.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2020\/06\/OrganChipTeam_AmirBeincheckingchips_H_2500.jpg?resize=350%2C200 1x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2020\/06\/OrganChipTeam_AmirBeincheckingchips_H_2500.jpg?resize=525%2C300 1.5x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2020\/06\/OrganChipTeam_AmirBeincheckingchips_H_2500.jpg?resize=700%2C400 2x"},"classes":[]},{"id":63237,"url":"https:\/\/news.harvard.edu\/gazette\/story\/2010\/10\/be-skinny-be-strong-be-loved-be-fooled\/","url_meta":{"origin":5198,"position":3},"title":"Be skinny, be strong, be loved \u2014 be fooled","author":"harvardgazette","date":"October 14, 2010","format":false,"excerpt":"Joshua Sharfstein, the Food and Drug Administration\u2019s principal deputy commissioner, talked about tobacco control and the agency\u2019s role in keeping Americans healthy.","rel":"","context":"In &quot;Health&quot;","block_context":{"text":"Health","link":"https:\/\/news.harvard.edu\/gazette\/section\/health\/"},"img":{"alt_text":"","src":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2010\/10\/101310_fda_042_605.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2010\/10\/101310_fda_042_605.jpg?resize=350%2C200 1x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2010\/10\/101310_fda_042_605.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":397755,"url":"https:\/\/news.harvard.edu\/gazette\/story\/2024\/11\/use-of-new-diet-drugs-likely-to-mushroom\/","url_meta":{"origin":5198,"position":4},"title":"Use of new diet drugs likely to mushroom","author":"Terry Murphy","date":"November 21, 2024","format":false,"excerpt":"Study estimates over half of Americans eligible to take them based on conditions, underscoring need to ensure equity of access.","rel":"","context":"In &quot;Health&quot;","block_context":{"text":"Health","link":"https:\/\/news.harvard.edu\/gazette\/section\/health\/"},"img":{"alt_text":"Two packages of 5 dosing pens eachof Semiglutin","src":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2024\/11\/semagludtide.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2024\/11\/semagludtide.jpg?resize=350%2C200 1x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2024\/11\/semagludtide.jpg?resize=525%2C300 1.5x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2024\/11\/semagludtide.jpg?resize=700%2C400 2x"},"classes":[]},{"id":322052,"url":"https:\/\/news.harvard.edu\/gazette\/story\/2021\/03\/ai-reveals-current-drugs-that-may-help-combat-alzheimers\/","url_meta":{"origin":5198,"position":5},"title":"Engaging AI in the battle against Alzheimer\u2019s","author":"harvardgazette","date":"March 4, 2021","format":false,"excerpt":"A team of researchers has developed an artificial intelligence-based method to screen currently available medications as possible treatments for Alzheimer\u2019s disease. The method could represent a rapid and inexpensive way to repurpose existing therapies.","rel":"","context":"In &quot;Science &amp; Tech&quot;","block_context":{"text":"Science &amp; Tech","link":"https:\/\/news.harvard.edu\/gazette\/section\/science-technology\/"},"img":{"alt_text":"MR image of human brain","src":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2021\/03\/iStock-sudok1.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/news.harvard.edu\/wp-content\/uploads\/2021\/03\/iStock-sudok1.jpg?resize=350%2C200 1x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2021\/03\/iStock-sudok1.jpg?resize=525%2C300 1.5x, https:\/\/news.harvard.edu\/wp-content\/uploads\/2021\/03\/iStock-sudok1.jpg?resize=700%2C400 2x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/posts\/5198","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/users\/105622744"}],"replies":[{"embeddable":true,"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/comments?post=5198"}],"version-history":[{"count":0,"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/posts\/5198\/revisions"}],"wp:attachment":[{"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/media?parent=5198"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/categories?post=5198"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/tags?post=5198"},{"taxonomy":"format","embeddable":true,"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/gazette-formats?post=5198"},{"taxonomy":"series","embeddable":true,"href":"https:\/\/news.harvard.edu\/gazette\/wp-json\/wp\/v2\/series?post=5198"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}