{"id":1133,"date":"2016-05-10T14:00:08","date_gmt":"2016-05-10T18:00:08","guid":{"rendered":"http:\/\/blogs.harvard.edu\/hlscasestudies\/?p=1133"},"modified":"2016-05-10T14:28:23","modified_gmt":"2016-05-10T18:28:23","slug":"product-highlight-margaret-hamburg-and-the-fda","status":"publish","type":"post","link":"https:\/\/archive.blogs.harvard.edu\/hlscasestudies\/2016\/05\/10\/product-highlight-margaret-hamburg-and-the-fda\/","title":{"rendered":"Product Highlight: Margaret Hamburg and the FDA"},"content":{"rendered":"

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photo by U.S. Dept. of Health & Human Services<\/a><\/em><\/p>\n

post by Nour Soubani, HLS Case Studies Assistant<\/em><\/p>\n

Almost every day, the Food and Drug Administration makes it into mainstream media news in one way or another. Whether it is about birth control, a cure for muscular dystrophy, or a recalled food product, the FDA is a key part of public health debates.<\/p>\n

The case Margaret Hamburg and the FDA<\/em><\/a> features the 2012 disagreement between the Commissioner of the FDA and the Secretary of Health and Human Services that ultimately resulted in the decision to distribute Plan B contraceptives, otherwise known as the morning after pill, over the counter. The case highlights the tension between the FDA and the Secretary of Health and Human Services and allows participants to experience the complexities of the decision making process from the point of view of FDA commissioner Margaret Hamburg. In a telling interview<\/a> in March 2013 with the Yale Undergraduate Journal of Politics, The Politic<\/em>, Hamburg said:<\/p>\n

\u201cI am very committed to running an agency where science and data drive our decision-making. But we are, of course, operating in world where there are many issues and concerns swirling around us, and where the decisions we make have very significant ramifications. We work closely with many stakeholders, including Congress. It is always a challenge to make sure that the best possible science is the one guiding our work\u2014but that is a challenge we must meet.\u201d<\/p>\n

This past January, Hamburg visited Harvard Law School. During her talk, she reflected on her time as FDA Commissioner, and the successes and challenges she faced in that role. One article in Harvard Law Today<\/em><\/a> covering the event reads, \u201cHamburg discussed how she learned to negotiate with the Washington establishment as commissioner. Early on, she said, she learned about the need for more transparency, predictability, and partnership.\u201d<\/p>\n

The questions raised by this case are similar ones about the protection of public welfare in the midst of a complicated relationship between the government and independent regulatory bodies. By reading not only about the case of Plan B contraceptives, but about the history of the FDA in general, students will be able to explore the nature of this relationship from all sides and think about effective ways to divide power between the entities involved.<\/p>\n

In Part A of the case, students will discuss important thematic questions like:<\/p>\n