US FDA chief speech on agency's turning point

The US Food and Drug Administration's Commissioner, Andrew von Eschenbach, has outlined his thoughts on the global changes that have brought the agency to a "turning point" and the measures that have been taken and remain on the agenda to "re-create" the FDA. Dr von Eschenbach was speaking to the National Press Club in Washington DC on the theme of FDA at a Turning Point: Meeting the Challenge of a Rapidly Changing World.

From "gold standard" to "not adequate"

In the 20th century, the FDA chief argued, the agency was successful and achieved recognition as "the world's gold standard regulatory agency." However, the unprecedented pace of technological change, Dr von Eschenbach said, means that "we are now creating medicines that don't just treat the manifestations of disease, but actually alter the biology of the living cell." The pace of growing demands on the FDA is outstripping the political will to fund its regulatory capacity. The Commissioner warned: "the simple truth as I see it today is that the FDA of the 20th century is not adequate to regulate the food and drugs of the 21st century..."