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FDA chief to step down after nearly six years

NEW YORK — 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, said Thursday that she was stepping down.

Hamburg, 59, told colleagues in an e-mail she would depart at the end of March. She said that she had never expected to stay as long as she did but kept finding issues she wanted to shape and problems she wanted to help solve. She said she was particularly proud of her role in modernizing how the agency regulated the safety of food and drugs from other countries.

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“Six years in this job is really a lot,” she said. “When I took over, it was often described as an agency in crisis. I’ve been able to turn that around to really improve morale and change the culture of the agency in some important ways. I hope that I’ve really made it a stronger and better place.”

One of the longest-serving commissioners at the agency, 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 FDA is a big agency. Its officials like to say that it regulates about 20 cents on every dollar spent by US consumers, and its authority extends from drugs and food to medical devices and tobacco. 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 said that the agency is making strides in an era that has brought new individualized treatments for small populations of patients based on genes

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“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,” said Dr. Thomas Frieden, the director of the Centers for Disease Control and Prevention.

Under Hamburg, the pace at which the agency approved drugs quickened, prompting praise from an industry that had chafed at a more cautious approval process following the regulatory scandal over Vioxx, an arthritis drug that was believed to have caused thousands of cardiac deaths before being pulled in 2004.

In a blog post earlier this week, Hamburg said the FDA 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 accused the agency of speeding approvals at the expense of safety, others said the pace was justified.

Nancy Goodman, the executive director of Kids v Cancer, a nonprofit advocacy group, praised Hamburg in an e-mail. 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.” The act is intended to provide market incentives to companies to develop drugs for children with rare diseases.

Some groups were critical. Dr. Michael Carome, the director of the health research group at Public Citizen, called her tenure a period “of weak and ineffective leadership.”

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“Too often, the FDA has succumbed to industry and political pressures, implementing policies and taking actions that tilt too far toward the bottom-line interests of pharmaceutical and medical-device companies and away from protecting public health,” he said in a statement.

But many specialists took issue with that, saying Hamburg could take a tough line with industry, although such stances were not obvious to the public.

A low point in her tenure came in the fall of 2012 when a pharmacy based in Massachusetts produced tainted epidural steroids that killed 64 people and sickened hundreds of others across the country with fungal meningitis.

She was grilled by lawmakers, who said she had not fulfilled her duties as leader of the nation’s top drug regulatory agency. But other analysts contended that the agency had limited legal power under the law — such pharmacies, known as compounders, were regulated by states, not the federal government — and that an accident had been bound to happen because of the murky legal framework. Congress later passed legislation clarifying the agency’s role.