WASHINGTON -- U.S. Food & Drug Administration (FDA) commissioner Margaret A. Hamburg has announced that she is stepping down at the end of March after six years.
In a letter emailed to FDA colleagues and employees, she discussed her time with the agency and detailed what she called the "significant progress" that the FDA has made in the areas of food and medical safety, as well as in the area of tobacco control.
"We made significant progress in implementing both the letter and spirit of the Family Smoking Prevention & Tobacco Control Act. 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 FDA with the launch of the agency's first public education campaigns to prevent and reduce tobacco use among our nation's youth."
She continued, "As Commissioner, my goal has been to shape and support an FDA that is well-equipped to meet the challenges posed by scientific innovation, globalization, the increasing breadth and complexity of the products that we regulate and our new expanding legal authorities. I have worked hard to advocate for FDA and our unique and essential mission, including building new partnerships to support our work. The agency has received numerous votes of confidence with the bipartisan enactment of a series of landmark bills extending our authority in the areas of tobacco, food safety and medical products."
She also expressed confidence in her successor.
"As hard as it is to leave this agency, 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. … And with respect to the agency's senior leadership team, I am pleased that Dr. Stephen Ostroff has agreed to serve as acting commissioner when I step down. Since joining the agency in 2013, and most recently serving as FDA's chief scientist, Dr. Ostroff has successfully overseen numerous significant initiatives, while helping to ensure that scientific rigor, excellence and innovation are infused across the agency. I have every confidence that he will take on this new role with the same energy, dedication and care."
Click here to read the full letter.
In related news, Hamburg recently appointed Robert Califf, M.D., a leader in cardiology, clinical research and medical economics, as FDA deputy commissioner for medical products and tobacco.
Califf will provide executive leadership to the Center for Drug Evaluation & Research, the Center for Biologics Evaluation & Research, the Center for Devices & Radiological Healthand the Center for Tobacco Products (CTP). He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.
He will play a critical role in providing high-level advice and policy direction on the agency's medical product and tobacco priorities and will manage cross-cutting clinical, scientific and regulatory initiatives in several key areas for the agency, including personalized medicine, orphan drugs, pediatric science, and the advisory committee system.
He will join the FDA in late February.
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