Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), has resigned, and will leave the agency at the end of March. Stephen Ostroff, FDA’s chief scientist and a former official at the Centers for Disease Control and Prevention, will temporarily fill the position until President Obama names an official successor. Just last week, Hamburg appointed Dr. Robert Califf of Duke University as FDA’s Deputy Commissioner. Califf is widely regarded as the frontrunner to replace Hamburg at the top.
During her six year tenure, Hamburg oversaw a wide range of initiatives including personalized medicine, disease control including the Ebola outbreak and antibiotic resistance, drug and device approvals, food safety, and tobacco control. Since 2009, FDA has also had to consider an increasingly global framework when crafting regulations, as well as new technology developments, including social media and mobile apps, that bring their own set of oversight challenges.
“As you can imagine, this decision was not easy,” Hamburg writes in a letter to her FDA colleagues. “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.”
She concluded: “I want to extend my deepest gratitude to each and every one of you for your service and for making FDA an agency that is not only an exciting and rewarding place to work, but also a place of remarkably meaningful achievement and impact on the health and well-being of Americans.”
View Dr. Hamburg’s Letter to her FDA colleagues.
Updated 2/5/15, 12:50pm:
The Pharmaceutical Research and Manufacturers of America (PhRMA) President and Chief Executive Officer, John Castellani, provided the following statement regarding Dr. Hamburg’s tenure:
“PhRMA salutes the work of Commissioner Hamburg and recognizes her significant contributions to the thoughtful regulation of medicines, including science as a basis for better regulatory decisions. For nearly six years, and to the direct benefit of patients, Commissioner Hamburg has demonstrated strong leadership and an unwavering commitment to collaboration with all stakeholders.
“We look forward to working with the FDA’s leadership and Acting Commissioner Ostroff to bring safe and effective innovative medicines to patients.”