The pharmaceutical industry has entered a critical period of transition. Business models that have proven remarkably successful over the past twenty years are now encountering major challenges. As companies grapple with the leading symptoms of these challenges — pricing pressures, pipeline productivity concerns, growing public distrust, and greater political scrutiny — it’s becoming increasingly clear that a profound shift is underway in the requirements for success in this environment.

Commercial practices in particular are receiving a level of scrutiny that would have been difficult to imagine just a few years ago. The FDA’s Office of the Inspector General (OIG) is conducting an on-going series of investigations into a broad range of practices by the industry. The Senate Finance Committee has also become extremely aggressive in conducting its own investigations. Meanwhile, leading media outlets such as the Wall Street Journal and leading medical journals like the New England Journal of Medicine have published a stream of editorials that are critical of industry practices.