Former Commissioners Call for the FDA to Be Made into an Independent Federal Agency

January 8, 2019

Washington, D.C., January 8, 2019 – Seven former Commissioners of the U.S. Food and Drug Administration, appointed by Presidents from both parties, have recommended that the FDA be moved out of the Department of Health and Human Services and transformed into an independent federal agency. Their position is outlined in a Health Affairs commentary co-authored by the Commissioners, accompanied by a white paper published by the Health, Medicine and Society Program (HMS) at the Aspen Institute.

The report follows the Commissioners’ announcing their consensus view at Aspen Ideas: Health (previously known as Spotlight Health) in 2016. Following this panel discussion, HMS received funding to convene an 18-month series of discussions with the Commissioners to help them develop their shared view that independence is the best pathway for FDA to meet the scientific challenges of the 21st century.

As part of this effort, HMS gathered supporting evidence, examining the role of the FDA in a time when science is rapidly evolving, products are becoming increasingly complex, and the economy grows ever more globalized. The FDA currently regulates roughly 20 cents of every dollar spent by American consumers each year. Research!America conducted background research, and the initiative was supported by a grant from the Laura and John Arnold Foundation.

The Commissioners who reached consensus and their terms were: Robert Califf, MD (2016-17); Margaret Hamburg, MD (2009-15); Andrew von Eschenbach, MD (2006-09); Mark McClellan, MD, PhD (2002-04); Jane Henney, MD (1999-2001); David A. Kessler, MD, JD (1990-97); Frank Young, MD, PhD (1984-89).

In the conclusion to the Health Affairs commentary, the Commissioners write, “FDA policies and actions are not driven by partisan politics: The scientific foundation for its decision making is guided by legislation that almost invariably has strong bipartisan support. We believe that our recommendations fit squarely within that bipartisan tradition of keeping the agency as up-to-date and effective as possible. Carrying out these reforms would enable the FDA to better fulfill its increasingly complex, challenging, and critical mission to promote and protect the health of the public.”

For more information about the report, or to request an interview, please contact Jon Purves: [email protected]

The Health, Medicine and Society (HMS) Program at the Aspen Institute, established in 2005, gathers together academic, government and industry leaders to explore health care and health policy and consider their impact on individuals, families, and communities across the United States.

The Aspen Institute is an educational and policy studies organization based in Washington, DC. Its mission is to foster leadership based on enduring values and to provide a nonpartisan venue for dealing with critical issues. The Institute is based in Washington, DC; Aspen, CO; and on the Wye River on Maryland’s Eastern Shore. It also has offices in New York City and an international network of partners. For more information, visit www.aspeninstitute.org.

Contact: Jon Purves
Senior Media Relations Associate
The Aspen Institute
[email protected]

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