Prologue: big scandals, higher prices. Pharma under Fire ; A note before we begin ; The strange economics of pharmaceuticals ; Generics, a brief primer -- Introduction: the winding road to generic entry -- "Generation 1.0": the rise and fall of traditional pay-for-delay. The basic contours of pay-for-delay ; Pay-for-delay as a bottleneck to entry ; Is pay-for-delay actually wrong?: pharma heads to the supreme court -- "Generation 2.0": complicating pay-for-delay. Already steps ahead of Actavis ; In re Lipitor: everything but the kitchen sink ; The post-Actavis landscape, contract clauses, and king drug -- "Generation 3.0": new tactics for active obstruction of generics. A new generation of pharmaceutical delay ; product hopping and the purple pill ; New examples of product hopping ; Scout's honor in product hopping
"Generation 3.0": continued obstruction of regulatory pathways. REMS-based delay ; Delay via citizen petition ; Preventing the "skinny label": blocking carve-outs -- Empirical evidence of a citizen's pathway gone astray. Methodology ; Results ; The road ahead -- Conclusion: a call for systematic reform. Societal harms ; Systems, simplification, sunshine, and standards-based doctrines
Summary
In this book, Feldman and Frondorf explain how companies employ strategies that block generic medicines from the market and keep prices high
