Preemption and REMS: Evolving Risk Landscape for Generic Drug Manufacturers
Sponsored by Lexington Insurance Company
Download "Preemption and REMS: Evolving Risk Landscape for Generic Drug Manufacturers," a new Advisen whitepaper sponsored by Lexington Insurance Company. The report examines the doctrine of preemption, how it applies to the pharmaceutical sector, the critical Wyeth v. Levine Supreme Court decision, other pending cases, as well as their impact on generic drug manufacturers. The report also discusses new FDA requirements, including REMS, and the burdens they place on generic drug manufacturers, which piles on top of the strain from the seemingly eroding preemption defense. Key risk management techniques are proposed in this whitepaper, in addition to keen insights from industry experts.