Drug Shortages: Accumulating Federal Legislation as an Underlying Cause

This article considers the role of well-intentioned legislation over the past fifty years, including the 1984 HatchWaxman Act, the 2003 Medicare Modernization Act, and 2012 Generic Drug User Fee Act, and the 2015 Bipartisan Budget Act in inadvertently squeezing profitability out of the generic drug market and thereby serving as a true root cause of many drug shortages. Also considered are the potential effects on drug
shortages of more recent legislation, including the 2021 American Rescue Act
Plan and the 2022 Inflation Reduction Act.