FDA Chief Margaret Hamburg to Step Down

SILVER SPRING, Md. — Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), is stepping down from her role at the agency next month.

"It has been a privilege to serve as your FDA commissioner for almost six years. So it is with very mixed emotions that I write today to inform you that I plan to step down as FDA commissioner at the end of March 2015," she wrote in a letter to her staff.

Hamburg said the decision was not easy and her tenure at the FDA "has been the most rewarding" of her career. She cited accomplishments such as creating a modernized food safety system that will reduce foodborne illness and taking critical steps to reduce the death and disease caused by tobacco.

"At the heart of all of these accomplishments is a strong commitment to science as the foundation of our regulatory decision making and of our integrity as an agency," she said.

She also listed the implementation of the Family Smoking Prevention and Tobacco Control Act among the highlights of her tenure.

"Our tobacco compliance and enforcement program has entered into agreements with numerous state and local authorities to enforce the ban on the sale of tobacco products to children and teens; conducted close to 240,000 inspections; written more than 12,100 warning letters to retailers; proposed the extremely important foundational 'deeming' rule; and broken new ground for the FDA with the launch of the agency's first public education campaigns to prevent and reduce tobacco use among our nation's youth," Hamburg explained.

She is "confident that the leadership team we have in place will enable the FDA to capitalize on, and improve upon, the significant advances we've made over the last few years."

Hamburg became the 21st commissioner of food and drugs on May 18, 2009. As the second woman to be nominated for this position, she is an experienced medical doctor, scientist and public health executive.

Stephen Ostroff, the FDA's chief scientist, will fill Hamburg's position until a new commissioner is named. He joined the agency in 2013.

There is no word what effect, if any, Hamburg's leaving will have on tobacco policy issues. However, in late January, the FDA appointed Robert Califf, a recognized global leader in cardiology, clinical research and medical economics, as FDA deputy commissioner for Medical Products and Tobacco. Califf will take his post later this month.

In the position, he will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products, according to the agency.

He will also will "play a critical role in providing high-level advice and policy direction on the agency's medical product and tobacco priorities," according to the FDA.