Generic drugs, product safety, liability, and preemption

For a new article on these topics, take a look at Federal Preemption of Generic Drug Claims: Product Safety, Potential Regulatory Changes and Plaintiff Strategies in the Aftermath of Mensing and Bartlett by Eric Lindenfeld and Jasper Tran. Here is the abstract:

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 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. Not only has this immunity done nothing to combat the price of drugs, but it has also decreased incentives for generic manufacturers from engaging in thorough pre-market testing and studies, putting consumers of generic drugs at an increased risk of injury.

This paper proceeds in six parts. Part I provides background of federal preemption as well as the FDA’s "NDA" and "ANDA" approval processes for generic drugs. Part II explores the federal preemption analysis of generic drug claims made in three recent Supreme Court decisions. Part III explores in-depth the damaging effects that these decisions have on the safety of consumers, and the long-term vitality of the generic drug industry. Having established that preemption of generic drug claims is undesirable, Part IV identifies recent attempts by the FDA to introduce regulatory changes that eliminate preemption of generic drugs. Part V explores cutting edge strategies that have been used by plaintiff lawyers to circumvent, reframes and distinguishes the Supreme Court decisions. Part VI concludes.


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