PLIVA v. Mensing: generic consumers' unfortunate hand.

INTRODUCTION ................................................................................................ 210 I. DRUG APPROVAL PROCESS .......................................................................... 213 A. BRAND-NAME DRUG APPROVAL AND LABELING PROCESS ..................... 213 1. PRE-APPROVAL ...................................................................................... 213 2. POST-APPROVAL .................................................................................... 214 B. GENERIC DRUG APPROVAL AND LABELING PROCESS .............................. 218 1. PRE-APPROVAL ...................................................................................... 218 2. POST-APPROVAL .................................................................................... 220 II. THE FEDERAL PREEMPTION DEBATE’S EFFECT ON THE GENERICLABELING FRAMEWORK .................................................................... 227 A. GENERIC MANUFACTURERS’ REGULATORY FRAMEWORK BEFORE PLIVA V. MENSING: WYETH V. LEVINE AND THE SUBSEQUENT CIRCUIT SPLIT ...... 227 B. PLIVA V. MENSING PROCEEDINGS BELOW .............................................. 230 C. PLIVA V. MENSING .................................................................................. 234 D. IMPLICATIONS FOR CONSUMERS, HEALTHCARE PROVIDERS, AND STATES ....................................................................................................................... 236 III. THE NEED FOR A NEW FRAMEWORK .............................................. 244 A. INADEQUACIES OF THE CURRENT FRAMEWORK ....................................... 244 1. GENERIC MANUFACTURERS’ LACK OF DATA ....................................... 244