ABSTRACT
Robert Califf discusses the new ecosystem and priorities for the Food and Drug Administration (FDA) for precision medicine. Califf talks about how in the old ecosystem, academics worked on basic research, companies made drugs, insurers paid, and patients were passive recipients of brilliance. The FDA has issued guidance statements for companion diagnostic test and in vitro diagnostic test approval; however, as personalized medicine continues to evolve and drug and diagnostic companies are constantly in the process of innovating during drug and diagnostic test development, the FDA has faced criticism and industry dissatisfaction for not keeping up with the advances in personalized medicine and technologies. The FDA is planning a new approach: "new regulatory approaches will be needed to enable the Agency to provide appropriate oversight, in a way that is more suitable to the complexity and data-richness of this new technology", according to the Jen Madsen of Arnold & Porter LLC.
