{"id":374,"date":"2013-05-28T09:38:29","date_gmt":"2013-05-28T13:38:29","guid":{"rendered":"http:\/\/blogs.law.harvard.edu\/hlscasestudies\/?p=374"},"modified":"2013-08-28T16:58:55","modified_gmt":"2013-08-28T20:58:55","slug":"too-many-cooks-in-the-fda-kitchen","status":"publish","type":"post","link":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/2013\/05\/28\/too-many-cooks-in-the-fda-kitchen\/","title":{"rendered":"Too Many Cooks in the FDA Kitchen?"},"content":{"rendered":"

New Product:\u00a0Margaret Hamburg and the FDA<\/em><\/strong><\/h2>\n

In December 2011, long-standing tensions between the Food and Drug Administration and presidential cabinets came to a head: for the\u00a0first time<\/a>\u00a0in its history, a cabinet member publicly ordered the FDA to retract a regulation when Secretary of Health and Human Services Kathleen Sibelius overruled the FDA\u2019s decision to\u00a0dispense contraceptive pills over the counter to women under 17.<\/p>\n

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Secretary of Health and Human Services Kathleen Sibelius (left), with FDA Commissioner Margaret Hamburg<\/p><\/div>\n

FDA Commissioner Margaret Hamburg\u00a0stood behind<\/a>\u00a0her decision as \u201creflect[ive of] a body of scientific findings,\u201d\u00a0but Sibelius had a\u00a0different appraisal<\/a>\u00a0of the same information: \u201cI have concluded that the data […] do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.\u201d<\/p>\n<\/div>\n

The incident was far more than a difference in scientific judgment. Obama publicly backed<\/a> Sibelius. \u201cAs the father of two daughters,\u201d he wanted to see \u201ccommon sense\u201d applied to these regulations.\u00a0 They could not rule out the potential for misuse, if birth control were sold to children \u201calongside bubble\u00a0gum and batteries.\u201d<\/div>\n

 <\/p>\n

Many believed that the White House was making a political move; that the threat of backlash from conservatives, particularly while the Administration was promoting the National Health Care law, made it difficult for the Obama administration to push the envelope on technology and science. \u00a0But for the FDA\u2014which was formed in the 1880s to combat shoddy scientific protocol\u2014its clout as an autonomous regulator was on the line.<\/div>\n

 <\/p>\n

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Professor Philip Heymann\u2019s new case study,\u00a0<\/span>Margaret Hamburg and the FDA<\/a>, looks at this push-and-pull history of the FDA, replete with pressure from lobbyists, politicians, and administrations. The case study explains the FDA\u2019s history, role, and organizational structure and highlights the conflicts over such issues as side effect labels on medications, approval schemes for new medical devices, and unregulated drugs grandfathered into legal sale.<\/span><\/div>\n
<\/div>\n
With this case, Heymann presents an opportunity for students to grapple with conflicts between policy and science, and how they can best navigate these waters as future leaders. Case study participants consider Hamburg\u2019s role in balancing divisions of power, vague and broad statutes, and stakeholders in policy and science. How might Hamburg address these conflicts of interest? At what point (if any) should Hamburg threaten to resign? And would such a threat ultimately backfire? This case study was taught this semester in HLS Professor Todd Rakoff\u2019s Administrative Law course, as well as Professor Heymann\u2019s Decision-Making and Leadership in the Public Sector (Fall 2012) and the Senior Managers in Government program through the Kennedy School of Government (Summer 2012).<\/div>\n
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All educators and trainers can receive free review copies of this case through the Case Studies\u00a0website<\/a>. For more information, or to discuss how to adapt the case study for your academic or professional education needs, contact Lisa Brem, Case Studies Program Manager, at\u00a0lbrem@law.harvard.edu<\/a>.<\/div>\n","protected":false},"excerpt":{"rendered":"

New Product:\u00a0Margaret Hamburg and the FDA In December 2011, long-standing tensions between the Food and Drug Administration and presidential cabinets came to a head: for the\u00a0first time\u00a0in its history, a cabinet member publicly ordered the FDA to retract a regulation … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":5482,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[88580],"tags":[],"class_list":["post-374","post","type-post","status-publish","format-standard","hentry","category-case-study-program-blog-posts"],"jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p4CR8M-62","jetpack-related-posts":[],"jetpack_likes_enabled":true,"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/posts\/374","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/users\/5482"}],"replies":[{"embeddable":true,"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/comments?post=374"}],"version-history":[{"count":14,"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/posts\/374\/revisions"}],"predecessor-version":[{"id":379,"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/posts\/374\/revisions\/379"}],"wp:attachment":[{"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/media?parent=374"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/categories?post=374"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/wp-json\/wp\/v2\/tags?post=374"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}