Makary/Prasad Priorities for ‘A New FDA’

FDA commissioner Martin Makary and CBER director Vinay Prasad are listing five priorities for their vision of “a new FDA” that is based on gold-standard science and common sense. Writing in a JAMA Viewpoint article, the two say the agency “will transition from a purely reactionary healthcare system to one that is proactive, intellectually curious about underlying causes, and financially aligned to promote health, not just treat sickness.”

They list these priority areas: accelerating cures by developing pilot programs to deliver decisions to sponsors in weeks; unleashing artificial intelligence; healthier food for children; harnessing big data for researching root causes of chronic diseases and conducting postapproval monitoring of new products; and financial toxicity by supporting the national priority of most-favored-nation pricing of pharmaceuticals, as appropriate.