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Margaret Hamburg and the FDA Teacher's Manual

By:
 Philip Heymann and Lisa Brem  
Product number:
CSP003-FPT
Length:
4 pages
English:
PDF
Product Type:
Discussion-Based Case Study (Teacher's Manual)
Link to Faculty Author Page:
Published:
2015

This teacher's manual is for review only. If you would like to purchase this case study, go to the case study product page.

Abstract

The public disagreements between the Commissioner of FDA and the Secretary of Health and Human Services which came to a head in the 2012 decision to dispense contraceptive pills over the counter. It was symbolic of the historically tense relationship which existed between the two bodies.  The case discusses the history of FDA and the events and regulations which led to its role as a regulator of enormous importance and power. The case explores the factors leading to the divergent motivations and differences in points of view of FDA and the health officials at the White House and gives a chronology of similar disagreements.  

The case addresses the question of division of power and intervention by the government and independent regulatory bodies against a backdrop of vague and broad statutes.

This product also includes a B case epilogue to the Plan B controversy.

This Teacher's Manual aids instructors in the use of the case study Margaret Hamburg and the FDA in the classroom.  The Teacher's Manual consists of:

  • Synopsis of the case study
  • Positioning of the case study within a law school course
  • Learning objectives
  • Teaching plan 

Summary Teaching Plan

The case study is designed to introduce students to the topic, then stimulate active engagement by situating participants in the role of the prosecutor. This case is suitable for one or two class sessions, and was initially taught in one class session for an hour and a half.

Class discussion includes:

  • Introducing the opposing perspectives and class expectations.     
  • Establishing the controversy.
  • Weighing the decision to press charges and the factors to consider.
  • Understanding the strategy of plea bargaining.
  • Wrapping up with a discussion of the systemic issues facing prosecution in the United States.

Learning Objectives

  • Understand the roles of the regulator and the administration in ensuring public welfare.
  • Understand the nature of interactions, the underlying forces in play, and the inherent tensions in the powers of the administration and the regulating body in the US government setting.
  • Explore optimal structures for division of power and intervention by the government and independent regulatory bodies against a backdrop of vague and broad statutes.
  • Contemplate the sometimes opposing forces of policy and science in US government decision making.

Subjects Covered

Administrative Law, FDA, public health, role of regulators and the government

Setting 

Geographic: United States

Event Start Date: 2012

Hard Copy

For hard copies, please contact the HLS Case Studies Program at hlscasestudies@law.harvard.edu or +1-617-500-1038.

Accessibility

To obtain accessible versions of our products for use by those with disabilities, please contact the HLS Case Studies Program at hlscasestudies@law.harvard.edu or +1-617-500-1038.

Additional Information

Too Many Cooks in the FDA Kitchen?

Product Highlight: Margaret Hamburg and the FDA


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