Oct. 19, 2018
American University Washington College of Law’s Health Law and Policy Program and the Food and Drug Law Institute (FDLI) teamed up Oct. 19, 2018 to host “FDA: Past, Present, and Future.”
The FDA conference brought together leading scholars, practitioners, and policymakers from across the nation to discuss the past, present, and future of the Food and Drug Administration (FDA).
Over 50 conference speakers were in attendance, including former FDA Commissioners Robert Califf, Margaret Hamburg, David Kessler, and Andrew C. von Eschenbach. Former FDA Chief Counsels Richard Cooper, Peter Barton Hutt, Gerald Masoudi, and Daniel Troy also spoke.
Watch the plenary discussions with the former FDA commissioners and chief counsels here.
AUWCL Professor Lewis Grossman, the conference chair who specializes in FDA law, health law, and American legal history, and Adjunct Professor Daniel Kracov, also participated.
Grossman, along with FDLI President and CEO Amy Comstock Rick and American University President (and former U.S. Secretary of Health and Human Services (HHS)) Sylvia Mathews Burwell, offered welcoming remarks.
"While specifics may have changed (since working at HHS), the big questions remain," Burwell said, including how the FDA must respond to the increasing role of technology in health care, while allowing health care to become more affordable and accessible for all American families, and keeping a commitment to safety and effectiveness.
During the event's first plenary session, the former FDA commissioners discussed a variety of topics, including drugs prices, opioids, political pressures, and how the FDA should operate in an increasingly globalized world.
"One thing I spent a lot of time working on was how do we create more alignment and harmonization, and sharing of work load and information, with regulatory agencies around the world," said Hamburg, president of the American Association for the Advancement of Science and Foreign Secretary of the National Academy of Medicine. "It's an interesting challenge, because every country has their own sovereign law, but the reality is that products are coming, in whole or in parts, from countries all over the world through complex supply chains that cross many national boundaries and authorities, and we have to really figure this out."
Grossman called the conference "an extraordinary event" that discusses "every product area regulated by the agency— marks food and drug law’s coming-of-age as a robust, distinct discipline in the American legal academy and AUWCL’s leadership in the area. The conference also provides a historic opportunity for conversation between prominent practitioners, academics, and regulators. Finally, it represents a notable occasion for many of the FDA’s former commissioners and chief counsels to gather together and reflect on the agency’s past, present, and future.”
Grossman added, “I am especially proud that the conference is the product of a close working relationship between American University Washington College of Law and FDLI, the esteemed nonprofit organization that has helped shaped the field for nearly 70 years.”
The conference concluded with a reception honoring the scores of AUWCL alumni working in the food and drug law field, with remarks by Mitch Zeller ’82, director for the Center for Tobacco Products at the FDA.
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