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:
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.
