Michael Callam


This Note will discuss how the PPACA’s abbreviated approval pathway for biological products creates an expedited procedure to bring less expensive biologic drugs to the market, but ultimately fails to make those biologic drugs affordable because of its lack of provisions limiting insurers’ use of excessive cost-sharing requirements. Part II provides an overview of prescription drugs, compares biologics with traditional prescription drugs, and provides a brief legislative history of prescription drug laws. Part III analyzes the impact of the abbreviated approval pathway on biologic drugs’ costs to prescribed patients. It also examines the PPACA’s effects on biologics inclusion into health insurance plans. This Note will demonstrate how the PPACA continues to keep prescription biologic drugs unaffordable for insured patients by permitting private insurers to continue to include excessive cost-sharing requirements in insurance plans. Finally, Part IV proposes a recommendation by which the PPACA would be amended to include a modified version of current proposed legislation. To fully address the problem, Congress must formulate and enact legislation that properly protects patients from excessive out-of-pocket costs, while balancing the insurance companies’ interests to remain competitive and profitable.