FDA is under new management. Margaret Hamburg, M.D., was sworn in to her position as FDA commissioner May 22, 2009, by Health and Human Services Secretary Kathleen Sebelius. Dr. Hamburg is an authority on global health,public health systems, infectious disease, bioterrorism, and emergency preparedness. She served as the Nuclear Threat Initiative’s founding VP for the Biological Program. Before joining NTI, she was the assistant secretary for planning and evaluation, U.S.Department of Health and Human Services. Prior to this, she served for six years as the commissioner of health for the City of New York and as the assistant director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
Industry observers have high expectations for the new commissioner. “I hope the new commissioner will implement the Obama administration’s focus on fact- based analysis and increase, even further, the emphasis on a risk-based approach,” says Wade Speir,principal consultant, life sciences and healthcare practice, PA Consulting Group (paconsulting.com). “All too much effort and energy are still wasted by industry fixing minor items they believe will be caught rather than what they believe are more important issues that they do not think will be discovered or cited by inspectors.”