Loading... Please wait...

Case Studies Program Logo

Margaret Hamburg and the FDA Teacher's Manual

 Philip Heymann and Lisa Brem  
Product number:
4 pages
Product Type:
Discussion-Based Case Study (Teacher's Manual)
Link to Faculty Author Page:


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


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 +1-617-496-1316. When ordering, please let us know how many copies of confidential materials that you will need.


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 +1-617-496-1316.

Educator Materials

This teacher's manual is for review only. It contains a pdf file with the product listed above.

If you would like to purchase this case study, go to the case study product page. Please note that each purchase of this product entitles the purchaser to one download and use. If you need multiple copies, please purchase the number of copies you need. For more information, see Copying Your Case Study.

Additional Information

Too Many Cooks in the FDA Kitchen?

Product Highlight: Margaret Hamburg and the FDA


Registered User?

Sign in now

Not a User?

Create an account

Instructors can apply for Educator Access. Benefits include:
Benefits Include:

  • Educator Copies
  • Teaching Notes
  • Student Pricing

Contact us for more information.

Related case studies and educator materials