Outcomes research - the marketplace is demanding it, the pharmaceutical and device industries are pouring resources into it … and the FDA is waiting. That's the picture that Nancy Cahill, an attorney and consultant to McDermott, Will & Emery, painted of the US Food and Drug Administration's (FDA) approach to the evaluation of outcomes. So what is the FDA's view of outcomes research?‘It's learning’, according to Dr Louis Morris, Chief of Marketing Practices and Communications at the FDA. But he firmly believes that the FDA is capable of evaluating the scientific validity of outcomes research. Thus began the debate between Nancy Cahill and Louis Morris at the Congress on Health Outcomes & Accountability [Washington DC, US; December 1994].