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.
Administrative Law, FDA, public health, role of regulators and the government
Geographic: United States
Event Start Date: 2012
For hard copies, please contact Lisa Brem E-mail: firstname.lastname@example.org; Ph: +1-617-495-8689
Registered educators can download watermarked copies of this product at no cost. Please create an account or sign in to gain access to these materials. For more information about the Case Studies Program at Harvard Law School, or to request a teaching note for this case study, contact the Case Studies Program at HLSCaseStudies@law.harvard.edu or 617-495-8689.