On February 5, FDA announced that FDA Commissioner Margaret Hamburg, M.D. has reportedly informed agency colleagues via an e-mail that she will step down as Commissioner at the end of March 2015.  Hamburg said in her e-mail that her decision was “with mixed emotions,” and:

As you can imagine, this decision was not easy. My tenure leading this Agency has been the most rewarding of my career, and that is due in no small part to all of you – the dedicated and hard-working people that make up the heart of this Agency . . . While there is still work ahead (and there always will be), I know that I am leaving the agency well-positioned to fulfill its responsibilities to the American public with great success.”

… 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 . . . We can honestly say that our collective efforts have improved the health, safety and quality of life of the American people.

Hamburg is one of the longest-serving commissioners in recent years, for almost six years, first nominated by President Barack Obama and confirmed by the U.S. Senate in May 2009.  Prior to her FDA appointment, Hamburg was the New York City Commissioner of Health for six years in the 1990s and worked for the National Institutes of Health.  Under Hamburg’s leadership, FDA has proposed measures to improve speed development of drugs and other products for unmet needs, improve nutrition, ramped up inspections from overseas, and increased patient engagement in the drug development process.  Hamburg’s administration has handled new and emerging public health issues such as antibiotic-resistant bacteria, electronic cigarettes, abuse of opioid painkillers, and, most recently, the Ebola outbreak.  Hamburg also led FDA’s development of several new and significant statutory regulatory authorities, such as tobacco products, drug compounding, food safety, and biosimilars.

Dr. Stephen Ostroff, the FDA’s Chief Scientist, will be the Acting Commissioner until a new Commissioner is named.  Ostroff joined FDA in FDA in 2013 as Chief Medical Officer in the Center for Food Safety and Applied Nutrition and Senior Public Health Advisor to FDA’s Foods and Veterinary Medicine.  Prior to that, he was Deputy Director of the National Center for Infectious Diseases (NCID) at the Centers for Disease Control and Prevention (CDC) and was also Acting Director CDC’s Select Agent Program.

Last month, the agency named Dr. Robert Califf Deputy Commissioner for Medical Products and Tobacco to oversee the agency’s drug, medical device, and tobacco policy.  Califf is a well-known cardiologist and researcher from Duke University and many agency insiders consider Califf to be a potential successor to Hamburg.

We wish Dr. Hamburg well on her new journey and Dr. Ostroff with his new role as Acting Commissioner.