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FDA Commissioner: Gene Therapy Has Crossed 'Scientific Bridge'


In a video recently published by Politico, FDA Commissioner Scott Gottlieb, M.D., contends that gene therapy has crossed a "scientific bridge." From a regulatory standpoint, he said, that means FDA needs to consider how to "regulate the process" by which gene therapies are created for individual patients.
» Politico


PMC News

PMC White Paper Suggests Value Assessment Frameworks Could Undermine Personalized Medicine


In a white paper titled Personalized Medicine and Value Assessment Frameworks: Context, Considerations, and Next Steps, PMC contends that most value assessment frameworks still make sweeping conclusions about the economic worth of a particular treatment based almost exclusively on population averages. As a result, the paper contends, most value assessment frameworks could unintentionally discourage payers and providers from considering important information about a patient's biology, values and preferences that can improve health outcomes — especially when value assessment frameworks influence the coverage and payment decisions that determine whether patients have access to treatment options that will work for them.
» Personalized Medicine and Value Assessment Frameworks: Context, Considerations, and Next Steps (PDF)