The Times They Are a Changin’ – And So is FDA

By: Luciana Borio, M.D.

Today, at a public meeting of the FDA Science Board, the agency is releasing our progress report, FDA Science Moving Forward, highlighting advances that FDA has made since the Science Board’s 2007 report FDA Science and Mission at Risk. Also at this meeting, a Science Board subcommittee will present its recommendations on FDA’s regulatory science programs, scientific workforce, and collaborations.

Dr. Lu BorioAs our report FDA Science Moving Forward illustrates, FDA regulatory science programs have made dramatic advances in the last eight years. These advances are critical because, as I’m always reminded, regulatory science underpins virtually every decision we make at FDA.

Some of our early efforts focused on establishing an organizational framework to foster FDA’s vibrant scientific culture, with increasing opportunities for scientific collaborations and training of our staff.

FDA created the Office of the Chief Scientist and appointed a Chief Scientist, who was charged with working internally and externally to provide strategic leadership and advocacy for regulatory science and FDA scientists. Today that office, which I currently lead, has grown to also encompass offices dedicated to scientific professional development, counterterrorism and emerging threats, scientific integrity, toxicological research, women and minority health, as well as regulatory science and innovation.

In October of 2010, we outlined our broad vision for advancing regulatory science, followed by a more specific strategic plan in 2011 for our work within eight regulatory science priorities. Guided by these changes, we have successfully recruited additional top scientific talent to FDA, while strengthening our training programs and professional development opportunities for current staff. Importantly, we have developed new mechanisms and programs to leverage external expertise through a number of new partnerships and collaborations with our stakeholders, including the Centers of Excellence in Regulatory Science and Innovation.

FDA continues to keep pace with new science and technology, found in a growing number of medical product applications submitted for our review. For example, applications involving 3-D printing, devices incorporating nanotechnology and wireless controls, targeted drug therapies, and next generation sequencing technology are now commonplace in our regulatory portfolio.

Who would have imagined more than a century ago when FDA occupied a small office in the Department of Agriculture’s Bureau of Chemistry, that it would become what it is today—a leading regulatory agency with a public health reach that extends across the globe? More inspiring still have been the extraordinary advances in science and technology that have enabled FDA researchers to continually improve our food safety systems and help bring life-saving medical products from bench to bedside.

Although many challenges lie ahead, the progress report we are releasing today shows unequivocally FDA’s strong commitment to letting science guide our work of protecting and promoting the public health.

Luciana Borio, M.D., is FDA’s Acting Chief Scientist