New Technologies and Old Statuses: Challenges for 21st Century Food and Medical Product Regulation

Prof. R. Alta Charo, JD

University of Wisconsin and US Food & Drug Administration

Wednesday, February 2, 2011 - 12:30pm to 2:00pm

Theater, Coffman Memorial Union

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Charo events photos

Emerging technologies, especially those that offer dramatically different levels of control over nature, have certain features in common. In her lecture, Prof. Charo discussed how the science often moves rapidly and unpredictably. Methodologies for risk identification and assessment may not yet be developed, applications across many different product areas are in development simultaneously, and legal authorities designed for an earlier age may be a poor fit when it comes to defining, reviewing, and monitoring the use of these technologies in products ranging from eye shadow to food wrapping to chemotherapy agents. This presentation described some challenges and approaches in the design of a regulatory response that are as nimble and nuanced as the science beyond the products it oversees.

Moderator:

FACULTY.kennedy_shaun

Shaun Kennedy, BSE-ChE
University of Minnesota
Director, National Center for Food Protection and Defense (NCFPD)

Commentator:

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Pamela S. Krop, JD
St. Jude Medical
General Counsel and Corporate Secretary

The Deinard Memorial Lecture on Law & Medicine is co-sponsored by the University of Minnesota's Joint Degree Program in Law, Health & the Life Sciences and the Center for Bioethics.

Support for the series comes from the law firm of Leonard Street and Deinard and the Deinard family.

Alta Charo

R. Alta Charo, JD, is the Warren P. Knowles Professor of Law & Bioethics, University of Wisconsin Law School and School of Medicine & Public Health. She teaches a variety of courses covering bioethics, public health law, biotechnology policy, and torts. Her government positions have included work as a Senior Advisor in the Office of the Commissioner at FDA; Policy Analyst for the US Agency for International Development; and Legal Analyst for the Congressional Office of Technology Assessment. Her service on government advisory bodies includes work as a member of the Obama Administration transition team and the Clinton Administration's National Bioethics Advisory. She is currently a member of the National Academies' Board on Population Health, and was a member of its Board on Life Sciences (2001-2008) as well as a member of various Institute on Medicine (IOM) /National Research Council (NRC) committees on bioterrorism, vaccination programs, and drug safety. 

She was one of the authors of the National Academies' Human Embryonic Stem Cell Research Guidelines and served as a co-chair of its Human Embryonic Research Advisory Committee. She was elected to membership in the Institute of Medicine in 2006. Professor Charo holds a BA in Biology from Harvard University and a JD in Law from Columbia University Law School.