Dr. Margaret Hamburg, the commissioner of the Food and Drug Administration, who led the agency for nearly six years through a period of rapid change in medical science, announced Thursday that she is stepping down.
Dr. Hamburg, 59, told agency colleagues in an email that she would depart at the end of March. “As you can imagine,” she wrote, “this decision was not easy. My tenure leading this agency has been the most rewarding of my career.”
One of the longest-serving commissioners at the agency, Dr. Hamburg was nominated by President Obama and confirmed by the Senate in 2009. She had a behind-the-scenes leadership style that some criticized as not tough enough but others praised as the best way to be effective in an era of intensely partisan politics.
The F.D.A. is an immense agency. Its officials like to say that it regulates about 20 cents on every dollar spent by American consumers, and its authority extends from drugs and food to medical devices and tobacco. Dr. Hamburg has grappled with some of the biggest public health issues of the day: the opioid painkiller abuse epidemic, obesity and the rise of electronic cigarettes.
“She has really done a terrific job,” said Dr. Thomas Frieden, director of the federal Centers for Disease Control and Prevention. “In virtually every issue that arises, she grasps it quickly and deeply and asks questions that force people to see a different dimension of it.”
Dr. Hamburg has said the agency is making strides in an era that has brought a burst of new individualized treatments for small populations of patients based on genes In a blog post earlier this week, she said the F.D.A. approved 51 drugs in 2014, the most in almost 20 years. She called that a testament to its “innovative approaches to help expedite development and review of medical products that target unmet medical needs.”
While some have criticized the agency for speeding up approvals too much, others say the pace is justified.
Nancy Goodman, executive director of Kids V. Cancer, a nonprofit advocacy group, praised Dr. Hamburg in an email. Ms. Goodman, who lost a son to cancer, said she was grateful for the pace of pediatric cancer drug development, “including simpler faster and cheaper trials and the implementation of the Creating Hope Act pediatric rare disease priority review program.”
Daniel Carpenter, a Harvard University political scientist who studies the F.D.A., noted the drug-safety problems that plagued the agency in the years before she took over. “She led the agency out of crisis,” he said. “She got the funding. There’s a steadiness there. A sense that the agency is growing.”
Dr. Hamburg leaves as some in Congress are pushing for change in the regulation of food and drugs. A group of legislators has recently proposed combining the F.D.A.’s food safety capabilities with those of other agencies, such as the Department of Agriculture. There is also a proposal to streamline the agency’s drug approval authority.
Dr. Hamburg has a long background in public health. She was New York City’s health commissioner in the 1990s, at a time when tuberculosis had become increasingly resistant to standard drugs and long-term adherence to medicine was critical. She sent health care workers to patients’ homes to help them manage their drug regimens. Under her leadership, New York City increased cure rates and reduced tuberculosis significantly.
She comes from a family of prominent doctors. Her father was a renowned psychiatrist, and her mother was the first black woman to attend Vassar College and to graduate from the Yale University School of Medicine. Dr. Hamburg was the first New York City health commissioner to give birth while in office, and her children’s birth certificates bear her name in two places: as their mother and as health commissioner.
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