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The issue of prescription drug pricing and access has remained near the top of the public health care agenda for the past 40+ years despite several policy attempts designed to address this problem, most often nibbling on the edges. Yet, in the past 10 years there has been a notable change in policy design, more direct and greater in scope than previous attempts. This paper argues that although the Affordable Care Act, the most notable health policy achievement during this period, contained few provisions that broadly targeted prescription drug affordability, it represented an inflection point in the evolution of the health care regulatory state that re-calibrated public perceptions about the relationship between government and private health care institutions and henceforth enabled the creation of more ambitious and substantial policy. This paper will seek to explain how recent federal policies to address prescription drug pricing and access fit into the broader political development of the regulatory state, identity the emergence of new actors and barriers, and provide a model for how subsequent health policy may be pursued successfully.