FDA commissioner to stand down after six years: sources

[February 05, 2015]  By Toni Clarke

WASHINGTON (Reuters) - Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), who for almost six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine, disease control and drug approvals, is stepping down, according to a person briefed on the matter.

The White House is expected to announce Hamburg's resignation later on Friday, the person said. FDA spokeswoman Stephanie Yao declined to comment.

Hamburg, 59, is one of the longest-serving FDA commissioners in the modern era. She was nominated by President Barack Obama and confirmed by the U.S. Senate in May 2009 and last year was named the world's 51st most powerful woman by Forbes.

Dr. Stephen Ostroff, the FDA's chief scientist, will fill Hamburg's position until a new commissioner is named, said a second person familiar with the matter.

Late last month, the agency named Dr. Robert Califf, a prominent cardiologist and researcher from Duke University, to oversee its drug, medical device and tobacco policy. Califf is viewed by many as a potential successor to Hamburg.

A long-time public health official with extensive experience fighting AIDS and tuberculosis, Hamburg, who graduated from Harvard Medical School, previously served at the National Institutes of Health before becoming New York City's health commissioner. She was not available for comment.

Her resignation comes as the FDA prepares for what could be a significant transformation, spurred on the one hand by initiatives in Congress to further speed new drug development, and on the other by food safety advocates, backed by the President, who would like to see the creation of a separate agency combining the food safety functions of the FDA and the U.S. Department of Agriculture.

MORE ENGAGEMENT

Under Hamburg's leadership the FDA, which oversees products representing more than 20 cents of every dollar spent by U.S. consumers, has proposed measures to improve nutrition by limiting dangerous trans-fats in food and requiring restaurants to post calorie counts on menus. It has also beefed up inspections of food and drugs from overseas, and increased patient engagement in the drug development process.

The agency has introduced multiple measures to speed the development and review of new drugs. In 2014, the FDA approved 51 new therapies, the most in almost 20 years. In a blog post on Wednesday, Hamburg called the achievement "a testament ... to FDA's innovative approaches to help expedite development and review of medical products that target unmet medical needs."

During her tenure the FDA has confronted major public health issues, including the rise of antibiotic-resistant bacteria, the abuse of opioid painkillers, the emergence of electronic cigarettes and the outbreak of Ebola and other infectious diseases.

Her ride has not always been smooth. She faced hostile questioning by Republicans in Congress following a fungal meningitis outbreak in 2012 that killed dozens and sickened hundreds more. And she has been caught up in some controversial political battles.

In 2011, then Health and Human Services Secretary Kathleen Sebelius overruled the FDA's decision to allow an emergency contraceptive known as Plan B to be sold over the counter to young teenagers. Hamburg insisted Plan B was safe for use, and it was eventually approved two years later.

Hamburg was never a crusading commissioner in the way of one of her predecessors, Dr. David Kessler, who fought to bring tobacco under FDA regulation. But she has made her mark on multiple issues, including the use of targeted therapy to tailor medicines to an individual's genetic makeup. The FDA gained regulatory authority over tobacco products for the first time on her watch, in 2009.

Hamburg comes from a distinguished medical family. Her mother was the first African-American woman to attend Vassar College and to earn a degree from Yale University School of Medicine.

(Editing by Ian Geoghegan)

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