This article first appeared in the Pharmaceutical Compliance Monitor on October 14, 2013.
“The more sand that has escaped from the hourglass of our life, the clearer we should see through it.” –Jean-Paul Sartre
When discussing the prospect of change to the structure of the American health care system, a little background is in order. Historically, the pharmaceutical industry has yielded to certain cyclical patterns that emerge when a new drug or treatment is introduced to the marketplace or new regulations come into effect, resulting in an initial surge followed in time by greater restraints imposed from both the federal and state level. Since its inception in 2010, the Affordable Care Act has in many ways preempted these cycles as it seeks to provide a nearly universal health care blanket by constructing a new foundation made of regulatory building blocks aimed at shifting emphasis from a cost based to a performance driven philosophy that it believes will reduce fraud and waste, thereby lowering costs across the board. Within its folds exist a number of pharmaceutical specific studies and programs designed to more accurately police the industry as the federal government attempts to curtail spending. With the emergence of the ACA, today’s pharmaceutical companies find themselves in an all too familiar situation, overlooking a vast new horizon of potentiality while beset by a host of new rules, where the prospect of greater market opportunity grapples with the restrictions that accompany increased regulation. … Read more →