Law Commons^™

Who Can Afford It?: The Patient Protection And Affordable Care Act's Failure To Regulate Excessive Cost-Sharing Of Prescription Biologic Drugs , Michael Callam

Journal of Law and Health

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 …