Comparative Effectiveness: Will it Foster FDA–CMS Collaboration or Drive the Agencies Apart?
Update Magazine
March 31, 2009
Michael M. Gaba- Washington
The Obama Administration and the 111th Congress have agreed to spend $1.1 billion in federal funding on comparative effectiveness research as part of the $787 billion economic stimulus package known as the American Recovery and Reinvestment Act. The provider community, and particularly the industries developing the interventions to be compared, need to consider how this new policy and funding surge will impact how they invest their research and development resources and demonstrate their technologies are worthy of coverage and payment both by public and private sector insurers. While the House of Representatives and Senate agreed on the $1.1 billion price tag, they did not agree on the appropriate use of comparative effectiveness data. With cost versus clinical use being at the heart of the effectiveness debate, the balance of power between the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) may be shifting.
Update Magazine 2009, Issue 2
With permission from FDLI
READ: Comparative Effectiveness: Will it Foster FDA–CMS Collaboration or Drive the Agencies Apart?
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