Preemption and REMS: Evolving Risk Landscape for Generic Drug Manufacturers

preemption-rems-evolving-risk-landscape-generic-drug-manufacturers-lexington-2010-12-200x200December 2010

Advisen wrote a white paper that 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. Sponsored by Lexington Insurance Company, the 8-page paper 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.

Managing Risks in Light of Preemption and REMS

The U.S. Supreme Court’s 2009 decision in Wyeth v. Levine has thrust a spotlight on the preemption doctrine in the pharmaceutical sector. Dubbed as “the blockbuster business case of the century,” the Supreme Court ruled against the drug maker Wyeth, holding that pharmaceutical companies can be held liable for harm from medicines that carry warnings approved by U.S. Food and Drug Administration (FDA). The ruling is seen as a major defeat that could have long-lasting repercussions on the application of the preemption defense in product liability claims asserted against drug manufacturers. Amid uncertainties with respect to whether preemption will effectively shield drug manufacturers from liability, drug manufacturers are also facing stiffer regulatory hurdles and costs stemming from increased federal management initiatives such as Risk Evaluation and Mitigation Strategies (REMS). Implementation of effective risk management practices and procedures are key strategies for minimizing liability.

The trend against preemption as a shield against product liability claims based on state law and the emergence of REMS have dealt a big blow to the pharmaceutical industry, particularly to manufacturers of genetic drugs. To survive in the evolving pharmaceutical landscape, drug makers should set in place a number of risk management precautions and procedures.

Download White Paper: Preemption and REMS: Evolving Risk Landscape for Generic Drug Manufacturers

Download the white paper Preemption and REMS: Evolving Risk Landscape for Generic Drug Manufacturers