Margaret A. Hamburg, M.D., became the 21st Commissioner of Food and Drugs on May 18, 2009, only the second woman to serve in the position. Among her initiatives during her tenure at FDA, Dr. Hamburg oversaw the modernization of a food safety system to reduce foodborne illness; advancement of biomedical innovation through the approval of novel medical products in cutting-edge areas of science and medicine; the securing of a safer globalized food and medical product supply chain; and implementation of the Family Smoking Prevention and Tobacco Control Act to reduce the death and disease caused by tobacco.
At the center of her work was a focus on strengthening the agency’s ability to apply the best available science to the challenges before it, to allow the agency to respond to new technologies and to the opportunities afforded by the growing understanding of the underlying mechanisms of disease.
In the area of nutrition, FDA oversaw changes in several areas to promote more informed and healthier choices, such as helping reduce trans fat in processed foods, clarifying “gluten free” labeling, updating the Nutrition Facts on the food label, and finalizing rules to provide caloric information on chain restaurant menus and vending machines. Enhancement of the safety, effectiveness, and availability of medical products was achieved through a number of initiatives and actions, including new congressional authority for oversight of drug compounding, establishment of a regulatory pathway for biosimilar biological products, a substantial reduction in the time taken for pre-market review of new medical devices, and the rapid approval of crucial medicines for rare types of cancer, hepatitis C, type-2 diabetes, idiopathic pulmonary fibrosis, and other diseases.
As part of its new authority provided by Congress to regulate tobacco products, FDA entered into agreements with numerous state and local authorities to enforce the ban on the sale of tobacco products to children and teens; proposed an important rule to expand the types of products covered by the law; and launched a public education campaign to prevent and reduce tobacco use among our nation’s youth.
Dr. Hamburg received her M.D. from Harvard Medical School in 1983 and completed her residency in internal medicine at what is now New York–Presbyterian Hospital/Weill Cornell Medical Center. She conducted research on neuroscience at Rockefeller University, studied neuropharmacology at the National Institute of Mental Health, and later focused on AIDS research as assistant director of the National Institute of Allergy and Infectious Diseases.
From 1991 to 1997, Dr. Hamburg served as commissioner of the New York City Department of Health and Mental Hygiene. In this position she focused on improved services for women and children, promoted needle-exchange programs to reduce the spread of HIV, initiated the nation’s first public health bioterrorism defense program, and in particular, worked on curbing the spread of tuberculosis, a serious and resurgent public health threat in the 1990s. The latter initiative included sending health care workers to patients’ homes to make sure they completed the drug regimen, which became a model for health departments worldwide and led to a significant reduction in New York City’s TB rate over a five-year span.
Her distinctive service as an experienced medical doctor, scientist, and public health executive led to her election to membership in the prestigious Institute of Medicine in 1994, one of the youngest persons to achieve that honor. In 1997, Dr. Hamburg accepted the position of assistant secretary for policy and evaluation in the U.S. Department of Health and Human Services.
From 2005 to 2009, Dr. Hamburg was the senior scientist at the Nuclear Threat Initiative, a foundation dedicated to reducing the threat to public safety from nuclear, chemical, and biological weapons. From 2001 to 2005, as the foundation’s vice president for biological programs, she advocated for broad reforms to confront the dangers of modern bioterrorism as well as the threats of naturally occurring infectious diseases such as pandemic flu.