After 6-Year Reign, Hamburg Stepping Down from FDA

FDA Commissioner Margaret Hamburg on Thursday announced she is resigning from her position after leading the health agency for approximately the last six years.

Hamburg, the 21st commissioner of food and drugs and only the second woman to be nominated for the position, told her colleagues she is stepping down at the end of March. Stephen Ostroff, FDA’s chief scientist, has agreed to serve as acting commissioner.

“From creating a modernized food safety system that will reduce foodborne illness; advancing biomedical innovation by approving novel medical products in cutting-edge areas; and responding aggressively to the need to secure the safety of a globalized food and medical product supply chain, to taking critical steps to reduce the death and disease caused by tobacco, we have accomplished a tremendous amount in the last six years," Hamburg wrote in an email to her colleagues.

Hamburg noted a number of accomplishments in the food industry during her tenure, which included initiatives to promote healthy foods and finalize rules that require the disclosure of calories and other nutrition information on restaurant menus. 

The 59-year-old public health administrator managed an agency that was responsible for implementation of the most comprehensive food-safety law in generations: the four-year-old Food Safety Modernization Act. FDA has encountered challenges carrying out the law’s myriad mandates, and the agency was even sued for missing critical deadlines that Congress had imposed.

Hamburg’s legacy extends far beyond food safety into a number of areas over which FDA has oversight, including the pharmaceutical industry where she said the agency has taken steps to better protect consumers from the dangers of counterfeit, stolen, and contaminated drugs.

Daniel Fabricant, executive director and CEO of the Natural Products Association, said Hamburg was the longest-serving commissioner since David Kessler, who left the agency on Feb. 28, 1997 after leading FDA for more than six years.

Fabricant cited unprecedented enforcement actions in the dietary supplement industry and prompt removal of dangerous natural products such as DMAA (1,3-dimethylamylamine) from the market during the Hamburg era. Fabricant previously worked with Hamburg when he served as FDA’s director of the division of Dietary Supplement Programs.

FDA, the public health agency based in Silver Spring, Maryland, regulates products that comprise 20 cents of every consumer dollar spent on U.S. products, according to Hamburg. But the agency has been notoriously underfunded for years. Still, Hamburg told her colleagues that FDA’s budget has increased from $2.7 billion in fiscal year 2009 to nearly $4.5 billion in FY2015. The agency recently requested $4.9 billion for FY2016.

“As hard as it is to leave this Agency," she wrote, “I am confident that the leadership team that we have in place will enable FDA to capitalize on, and improve upon, the significant advances we've made over the last few years."

Hamburg announced her resignation just days after a key food-safety official joined the agency: Susan Mayne, the new director of the Center for Food Safety and Applied Nutrition (CFSAN).