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Margaret Hamburg and the FDA

By:
 Philip Heymann and Lisa Brem   (Published: 2013)
Product number:
CSP003
Length:
24 pages
English:
PDF
Product Type:
Discussion-Based Case Study
Link to Faculty Author Page:
Link to Free Educator Copy:

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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.

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 U.S. 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 U.S. 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 Lisa Brem E-mail: lbrem@law.harvard.edu; Ph: +1-617-495-8689

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