FDA’s Dueling Priorities

August 3, 2016

(The Atlantic) – Medical-device companies—unlike drug conglomerates—are predominantly small businesses, and the process of bringing their inventions to market can be prohibitively expensive. After a device is finally cleared, its design may become obsolete within a couple of years. For drug licensing, part of the time burden comes from the FDA’s dueling mandates of safety and efficacy, each of which requires different kinds of tests and controls. Each stage of research emphasizes the two factors to different extents, and these priorities are reflected in the experimental design. The weighting of safety and efficacy priorities remains a subject of debate.