By: Stephen Ostroff, M.D.
This is a very exciting time to be stepping into the position of Acting Chief Scientist at FDA. A relative newcomer to the agency, I joined FDA’s Center for Food Safety and Applied Nutrition seven months ago as chief medical officer and senior public health advisor for the Office of Foods and Veterinary Medicine.
But as the former deputy director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention and director of the Bureau of Epidemiology at the Pennsylvania Department of Health, I often worked with colleagues at FDA and have a solid appreciation for FDA’s public health mission and the pivotal role science plays in everything FDA does. So, I’m very enthusiastic about continuing the development of FDA’s scientific enterprise and positioning the Office of the Chief Scientist (OCS) to best support the agency’s scientific programs.
I’d like to take the opportunity over a series of blogs to discuss the important role that OCS plays in keeping our foods safe and nutritious and in getting essential therapies to the people who need them.
FDA has grown from a lone chemist in the U.S. Department of Agriculture in 1862 to an agency with a staff of 14,600 employees. More than 65% of them are scientific and technical staff, representing disciplines such as biologists, nurses, pharmacists, physicians, veterinarians, behavioral scientists, statisticians, epidemiologists, economists and engineers.
FDA requires this breadth and depth of expertise to ensure that science informs the decisions we make about the safety and effectiveness of drugs, biologics, and medical devices, the safety of foods and cosmetics, and the regulation of tobacco products, particularly as those products become increasingly complex. Only then can the public be confident that these products are rigorously reviewed and assessed before and after they go to market.
Transformative changes in society and technology over the past several decades have created numerous opportunities to improve public health. They’ve also created challenges affecting FDA-regulated products and the way FDA conducts its operations.
For example, globalization is bringing an increasing volume of foods and drugs to our shores, often produced in countries that may not have our high standards of regulatory oversight. New areas of science and rapidly evolving technologies are showing real promise in our ability to prevent and cure some of today’s biggest killers, such as diabetes, cancer, and Alzheimer’s.
To meet these challenges, we are "advancing regulatory science." In other words, we are developing the new tools, methods and approaches that will be needed for a globalized regulatory environment and for translating new discoveries into innovative medical treatments. But advancing regulatory science research and training requires multidisciplinary and interdisciplinary collaboration within FDA and with our partners in academia, industry, other government agencies and with patient advocates. OCS works to meet these goals by strengthening FDA’s scientific infrastructure, forging a common vision, and working with our stakeholders to identify critical regulatory science and innovation needs.
In my future blogs, I will discuss examples of the exceptional work underway in the different OCS components – the National Center for Toxicological Research (NCTR), the Office of Counterterrorism and Emerging Threats, the Office of Minority Health, the Office of Regulatory Science and Innovation, the Office of Scientific Integrity, the Office of Scientific Professional Development, and the Office of Women’s Health. I can think of no more exciting place to be than at the core of FDA’s pioneering regulatory science culture.
Stephen Ostroff, M.D., is FDA’s Acting Chief Scientist