FDA Commissioner Margaret Hamburg Details “Regulatory Science” for 21st Century Medicine

Universities, industry, and government must join to develop state-of-the-art “regulatory science” that can speed evaluation of new drugs and medical procedures and bring them more quickly to patients, Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, told a AAAS audience.

Advanced research and technology are driving remarkable new discoveries, Hamburg said, but the United States’ current process of evaluating and approving them for use dates to an earlier era. The resulting gap between new discoveries and older treatments already on the market—some have termed it the “valley of death”—brings risk not only to patients, but to the nation’s economy and innovation culture, she said.

“We live in a time when science and technology are changing our world in dramatic ways,” Hamburg said. “We are seeing an explosion of knowledge and capabilities emerging from many domains of research and from around the globe. And with that comes a fundamental question of how do we make sure that we fully translate the potential and promise of that research into real-world products and programs that really matter.

Hamburg delivered a luncheon address at the 35th annual AAAS Forum on Science and Technology Policy.

To learn more about her views on regulatory science, and to find multimedia materials from her talk, read the full story.