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FDA Approves Record Number of Personalized Medicines in 2017


A new PMC report documents the record number of new personalized medicines the U.S. Food and Drug Administration (FDA) approved last year, making 2017 the fourth consecutive year that personalized medicines accounted for more than 20 percent of all new drug approvals. The annual analysis, titled Personalized Medicine at FDA: 2017 Progress Report, shows that FDA approved a record number of 19 personalized medicines — 16 new molecular entities and three gene therapies — in 2017. The report lists a total of six regulatory precedents FDA set last year.
» Personalized Medicine at FDA: 2017 Progress Report


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)