Living With REMS: The New Regulatory Model Meets Commercial Reality
Article preview reprinted from IN VIVO - April, 2009
Harvey Katzen, MD, has a complaint. As a busy physician running a hematology and oncology practice in suburban Maryland, he's frustrated that two new drugs, both of which were recently approved to combat an unusual blood disorder called chronic ITP, require a lot of extra paperwork before a patient can begin treatment.
Article preview reprinted from IN VIVO - April, 2009
Living With REMS: The New Regulatory Model Meets Commercial Reality
Welcome to the new reality for pharmaceutical marketing. The paperwork for Amgen's Nplate and GlaxoSmithKline's Promacta is part of a formal Risk Evaluation and Mitigation Strategy, or REMS. The REMS system was created to give FDA greater authority to impose and enforce risk management plans, to address far-ranging concerns about drug safety and the FDA's credibility. Promacta and Nplate are among the first products approved under the new law--and hence provide an early opportunity to see how the new regulatory system plays out in the commercial marketplace.
Purchase this article online as a PDF and receive it immediately via email. Questions? Call (800) 332-2181. 100% Satisfaction Guaranteed. Subscribe to IN VIVO.
Companies mentioned in this article:
Amgen Inc.
Biogen Idec Inc.
GlaxoSmithKline PLC
Roche Genentech Inc.
IN VIVO delivers:
- Revealing, in-depth coverage of your competitors' strategies
- Incisive projections of future industry trends and their implications for your business
- Expert analysis of key industry developments
- Exclusive interviews with top industry executives and analysts
- In-depth examination of dealmaking, marketing, R&D, regulatory, and finance strategies -- those that were successful and those that missed the mark
- Subscribe to IN VIVO today!
