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The New World for New Drug Approvals: Evolution in Strategies for Getting FDA Drug Approvals

This article was originally published in RPM Report

Executive Summary

Pharma is adjusting rapidly to a new regulatory world: one in which post-marketing risk management plans change the relationship of the company to doctors and patients and one where FDA's expectations for pre-marketing information about product markets are likely to expand dramatically.

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Living With REMS: The New Regulatory Model Meets Commercial Reality

Amgen and GSK are competing head-to-head in a new market for a rare blood disorder. The market size is small, but the commercial implications are huge: how will the new regulatory tools imposed by FDA affect competition in the real world?

Living With REMS: The New Regulatory Model Meets Commercial Reality

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. 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.

Living With REMS: The New Regulatory Model Meets Commercial Reality

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. 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.

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