In Transition: FDA Administrator

Wednesday, November 26, 2008

Robert M. Califf

Current job: Vice chancellor for clinical research, director of the Translational Medicine Institute and professor of medicine in the division of cardiology at Duke University School of Medicine.

Credentials: Califf, 57, has served on the FDA's cardio-renal advisory panel and on several Institute of Medicine (IOM) committees, including the Pharmaceutical Roundtable. He is a member of the IOM Forum on Drug Discovery, Development and Translation. He was the founding director of the Duke Clinical Research Institute and of the coordinating center for the Centers for Education and Research on Therapeutics, a public-private partnership among Duke, the Agency for Healthcare Research and Quality, academia, the medical products industry, and consumer groups, which focuses on advancing the best use of medical products. He is a graduate of the Duke University School of Medicine.

What he offers: Califf is a respected researcher and administrator involved in scientific and policy issues. He serves on a subcommittee of the FDA's Science Board that produced a highly critical comprehensive evaluation of the agency in 2007.

Quote: "The FDA is full of valiant people who have been working harder and harder with inadequate support. The organization needs some help. The pace of science is changing faster than the organization's ability to respond to it. And globalization is hitting us like a freight train."

Steven E. Nissen

Current job: Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation.

Credentials: Nissen, 60, was a member of the FDA's cardio-renal advisory panel for five years and chaired the committee during his final year. He continues to serve as a periodic adviser to several FDA panels. Nissen, who graduated from the University of Michigan School of Medicine, has also served as president of the American College of Cardiology.

What he offers: Nissen has become a high-profile voice calling for better drug safety regulation. Most recently, he raised concerns about the safety of the widely used diabetes drug Avandia.

Quote: "We face a crisis in public confidence in the FDA following an unprecedented series of revelations about drug and device safety. . . . Strong and decisive legislative action is now essential to improve safety of drugs and medical devices and restore public confidence in this critically important regulatory agency."

Joshua M. Sharfstein

Current job: Baltimore city health commissioner

Credentials: Sharfstein previously served as health policy adviser on the Democratic staff of the House Oversight and Government Reform Committee, working for Rep. Henry A. Waxman (D-Calif.). He is a graduate of Harvard Medical School.

What he offers: Sharfstein, 39, won national attention this year when he led an effort to get the FDA to reevaluate the safety and effectiveness of commonly used over-the-counter cough and cold medications in children. He also has started innovative programs as Baltimore's health commissioner, including one to improve drug addiction treatment.

Quote: "The principal challenge for the agency is to reestablish its credibility. That is important for patients, consumers and the industry. When the agency loses credibility, you have a crisis that affects people and undermines confidence in the overall regulatory system, and that's not good for anybody."

Susan F. Wood

Current job: Research professor, George Washington University School of Public Health and Health Services.

Credentials: Wood served as the FDA's assistant commissioner for women's health and director of the FDA's Office of Women's Health from November 2000 through August 2005. She previously served as director for policy and program development at Health and Human Services' Office on Women's Health. She has a PhD from Boston University.

What she offers: A respected administrator while at the FDA, Wood, 50, won praise for resigning in protest over the agency's delay in approving sale of the Plan B emergency contraceptive without a prescription. She worked on Capitol Hill from 1990 to 1995.

Quote: "The FDA is an agency that has been taken off track, and we truly need FDA to return to its mission of protecting and promoting the public health. One key way that it can accomplish this is by ensuring that FDA scientific staff are supported, and by ensuring that decisions made by the agency are based on the best available science and medical evidence."

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