Dear Colleagues,
It is my great honor to be sworn in today as the 22nd head of the Food and Drug Administration. As a physician whose career has been devoted to advancing the public health and treating disease, I can think of no better place to be than this esteemed agency whose essential role is succinctly captured in our powerful mission statement -- to protect and promote the public health.
Over the last year, while serving as Deputy Commissioner for Medical Products and Tobacco, I’ve seen first-hand the gravity, significance, and opportunity of the work being done at FDA. The genesis and catalyst of our success is our outstanding workforce, which allows us to fulfill our mission at the highest standards. This effort comes against the backdrop of extraordinary new challenges resulting from vast changes in our global environment that have altered virtually every aspect of production, distribution, and regulation of the products we oversee. And in addition, as the related industries and practices have become more sophisticated, the proliferation of information about these products creates an exciting challenge for us as we assimilate knowledge from an increasing array of global sources.
The good news is that alongside these changes have come enormous opportunities afforded by revolutionary advances in science and technology. By embracing and maintaining the expertise to keep pace with these changes in agriculture, engineering, biomedicine and information technology, FDA continues to ensure the safety of all Americans. My single most important priority going forward is to support and strengthen FDA’s remarkable workforce so that we can continue in our ability to keep up with our rapidly changing world. That’s what the American public expects and deserves.
Of course, befitting a time of such great change, challenge, and opportunity, we have many other priorities to address as well. Some of these have been a long time in development, and I look forward to helping to move them across the finish line. In other areas of focus I look forward to continuing our work as we strengthen and enhance our ability to find answers. I’m speaking here of efforts like the continued implementation of the landmark Food Safety Modernization Act, the Deeming Rule for Tobacco products, the Precision Medicine initiative, which is helping to transform the development of treatments for disease, and our work to combat the growing opioid abuse crisis that has had such tragic consequences for individuals and their families across our nation.
In each of these areas, as well as across the many other diverse areas of our responsibility, our work will be guided, supported, and advanced by the continued development of our scientific ability and capacity. Rigorous science lies at the core of our work, and it is essential that we are able to take advantage of the most advanced scientific tools to allow us to provide informed, science-based regulation. This helps us unlock new evidence, creates pathways for innovation, lowers costs, and, ultimately, allows us to better protect the American public. So as Commissioner I look forward to doing everything possible to further develop our science base.
A particular area of science that is now at a “tipping point” is the system needed to generate the evidence we need to make good decisions across the spectrum of food, tobacco, animal products and medical products. We will be working diligently to take advantage of our nation’s investment in electronic health records and FDAs tremendous work with projects like Sentinel and the National Device Evaluation System to develop a more efficient system that can generate much more high quality evidence in a shorter time.
When it comes to finding solutions for challenges facing the FDA, there is no greater resource than the one presented through engagement and outreach with patients, as well as their families, caregivers, and advocates. Including their perspectives and voices in our work along the entire medical product continuum, from development to review and evaluation to post-market surveillance, offers opportunities to enhance our knowledge of the benefits and risks of medical products.
My own commitment to strengthening public health comes as much from personal experience as from my professional background. My family not only supported my work and research but on a very personal level helped inform my understanding of disease and the urgency of combatting it. They have shaped who I am and reinforced my belief in the promise and power of medicine and science. It is with a great debt to their love and guidance that I look forward to following in the footsteps of the many great leaders in the field of public health who have preceded me in the position I assume today.
To that end, I want to offer my sincere respect and gratitude to Dr. Stephen Ostroff, who, for the last year, has served as Acting Commissioner of Food and Drugs. I am pleased that Dr. Ostroff has agreed to remain in the Office of the Commissioner temporarily to ensure a seamless transition. His expertise in the field of public health, and his leadership, collegiality, and deep commitment to the mission of the FDA, has helped advance the work and reputation of the Agency. As I have come to know him, I have learned that he is not only one of the most modest and unassuming people, but also one of the most capable. Few people could have filled the role he did with such aplomb. On behalf of the FDA and a grateful public, I thank him.
I look forward to my responsibilities, the new challenges, and most of all, to meeting and collaborating with all of you, our remarkable FDA workforce.
Sincerely,
Robert M. Califf, M.D.
Commissioner of Food and Drugs
