The Affordable Care Act (ACA) has elicited intense national debate and sent biopharmaceutical companies scrambling to understand how their business model, including its ability to innovate, will change as healthcare reform moves forward.  Within this uncertain market, what is obvious is that the industry is in the midst of significant transition.  Critical drivers of this change are largely macroeconomic; policy is simply accelerating change.  Understanding this backdrop is crucial as the biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare in the United States.