Product Highlight: Margaret Hamburg and the FDA

photo by U.S. Dept. of Health & Human Services

post by Nour Soubani, HLS Case Studies Assistant

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.

The case Margaret Hamburg and the FDA 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 in March 2013 with the Yale Undergraduate Journal of Politics, The Politic, Hamburg said:

“I 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—but that is a challenge we must meet.”

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 covering the event reads, “Hamburg 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.”

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.

In Part A of the case, students will discuss important thematic questions like:

  • What is the role of the regulator? The administration?
  • What are the qualities of an effective regulator?
  • What happens if and when their objectives conflict?
  • How are tensions in power reconciled? How might they be?
  • How are decisions made?
  • When, if ever, should science trump policy? When should policy trump science?
  • What gets in the way of science or policy prevailing as they should?

In Part B, students will be able to read about the press releases that came out of the case as well as discuss the future of the FDA and its relationship with the government.

The case of Margaret Hamburg and the FDA will allow students to put themselves in the shoes of both scientists and policymakers attempting to answer difficult questions about the integrity of protecting public welfare. It is a complex and intriguing case that covers many relevant issues in science and politics today.

The case and supplementary materials can be found on the Harvard Law School | The Case Studies website. Educators registered on our website will have free access to the teaching manual for this case.

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