New Product: Margaret Hamburg and the FDA
In December 2011, long-standing tensions between the Food and Drug Administration and presidential cabinets came to a head: for the first time in its history, a cabinet member publicly ordered the FDA to retract a regulation when Secretary of Health and Human Services Kathleen Sibelius overruled the FDA’s decision to dispense contraceptive pills over the counter to women under 17.
Secretary of Health and Human Services Kathleen Sibelius (left), with FDA Commissioner Margaret Hamburg
FDA Commissioner Margaret Hamburg stood behind her decision as “reflect[ive of] a body of scientific findings,” but Sibelius had a different appraisal of the same information: “I have concluded that the data […] do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.”
The incident was far more than a difference in scientific judgment. Obama
publicly backed Sibelius. “As the father of two daughters,” he wanted to see “common sense” applied to these regulations. They could not rule out the potential for misuse, if birth control were sold to children “alongside bubble gum and batteries.”
Many believed that the White House was making a political move; that the threat of backlash from conservatives, particularly while the Administration was promoting the National Health Care law, made it difficult for the Obama administration to push the envelope on technology and science. But for the FDA—which was formed in the 1880s to combat shoddy scientific protocol—its clout as an autonomous regulator was on the line.
Professor Philip Heymann’s new case study, Margaret Hamburg and the FDA, looks at this push-and-pull history of the FDA, replete with pressure from lobbyists, politicians, and administrations. The case study explains the FDA’s history, role, and organizational structure and highlights the conflicts over such issues as side effect labels on medications, approval schemes for new medical devices, and unregulated drugs grandfathered into legal sale.
With this case, Heymann presents an opportunity for students to grapple with conflicts between policy and science, and how they can best navigate these waters as future leaders. Case study participants consider Hamburg’s role in balancing divisions of power, vague and broad statutes, and stakeholders in policy and science. How might Hamburg address these conflicts of interest? At what point (if any) should Hamburg threaten to resign? And would such a threat ultimately backfire? This case study was taught this semester in HLS Professor Todd Rakoff’s Administrative Law course, as well as Professor Heymann’s Decision-Making and Leadership in the Public Sector (Fall 2012) and the Senior Managers in Government program through the Kennedy School of Government (Summer 2012).
All educators and trainers can receive free review copies of this case through the Case Studies
website. For more information, or to discuss how to adapt the case study for your academic or professional education needs, contact Lisa Brem, Case Studies Program Manager, at
lbrem@law.harvard.edu.
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About Elizabeth Moroney
Case Studies Editorial Assistant
