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Data = Safety and Effectiveness

September 4, 2009
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Posted by Georgia Relich

I attended Centric Health Resources’ conference on the “Emerging Commercialization Strategies for Addressing the Needs of Ultra-Orpha Patients” last week. The conference sessions focused on the topic of accelerating product launch by considering Regulatory Requirements in the distribution approach. Lots of interesting discussion around:

1. REMS, a relatively new FDA mandate, which most simply put is a required document that ensures the benefits of a drug outweigh the risks.

2. Comparative Effectiveness (that’s the newest buzz word), which means comparing two or more treatments for a given condition (think stents vs CABGs). Why the buzz? About $700 billion each year goes to healthcare spending that doesn’t lead to better outcomes. Currently, there is $1.1 billion being spent on comparative effectiveness research. That’s a lot of jobs for the AHRQ and NIH.

3. Pay for Performance, programs for hospitals and physicians that reward quality, safety and outcomes.

4. Evidence-based treatments, which puts a greater emphasis on the outcomes.

Hard to know how these new accountability measures will affect any of us, but it appears there will probably be good data accumulated on drug outcomes, hopefully leading to safer and more effective treatments.

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