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US Policy Update

PMC to CMS: To Increase Value, Incentivize Tailored Care


In response to a Wall Street Journal op-ed and request for information about innovative ways to pay for and deliver health care in the U.S., PMC has encouraged the Centers for Medicare & Medicaid Services (CMS) to spearhead models that empower physicians to move away from the current standard of care when patient outcomes can be improved by tailoring care to a patient's genetics and other factors. In keeping with PMC's mission to underline the significance of personalized medicine to patients and the health system, the Coalition's comment letter contends that personalized medicine products and services can increase the overall value of dollars spent by improving health outcomes.
» PMC comment letter (PDF)


International Policy Update

EMA to Update Regulatory Guidelines for Personalized Medicine Tests


To keep up with the pace of progress in personalized medicine, the European Medicines Agency (EMA) plans to update the regulatory guidelines applicable to certain kinds of personalized medicine tests. In its comments about the associated Concept Paper on Predictive Biomarker-Based Assay Development in the Context of Drug Development and Lifecycle, PMC commends the agency for its effort to revise guidelines applicable to the regulation of so-called “companion diagnostics,” which are still subject to guidelines established in the EMA’s 2010 reflection paper about the topic.
» PMC comment letter (PDF)