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Full-Text Articles in Law
Thoughts On Preemption In The Wake Of The Levine Decision, Erika Lietzan, Sarah E. Pitlyk
Thoughts On Preemption In The Wake Of The Levine Decision, Erika Lietzan, Sarah E. Pitlyk
Faculty Publications
This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s decision in Wyeth v. Levine. Part I describes the Levine decision. Part II examines the majority’s holding as it relates to impossibility preemption and considers the future of the doctrine in failure-to-warn suits after Levine. We argue that the announced standard for impossibility preemption — the clear evidence standard — should be interpreted reasonably and not in a manner that effectively eviscerates the doctrine. We also describe other instances of impossibility in the food and drug regulatory context that were not presented to the Court. …
Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan
Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan
Faculty Publications
On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from …