Beyond Preemption of Generic Drug Claims

Read the full article (PDF) >

Recent research indicates that the current cost of generic medications in the United States is the highest in history. Many patients are no longer able to afford life saving medications that were once affordable only five years ago. Concurrent to the rising prices of generic drugs, pharmaceutical companies have lauded preemption as a necessary and viable solution to combat the increasing prices. Two recent Supreme Court decisions, PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, have agreed with this logic, and have attempted to pervert the Hatch-Waxman Act, and its corresponding ANDA approval process to shield generic drug manufacturers from liability.