On February 21, 2020, the Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: The Scope and Significance of Progress in 2019” (Report) that monitors FDA approvals of precision medicine therapies and diagnostic assays.
Several milestones were noted for 2019 - ranging from new drug approvals to the first FDA qualified digital technology software.
According to the PMC, much of the progress over the last several years can be attributed to the commitment of scientists and FDA toward moving from a one-size to fit all to a personalized approach. “This progress is largely due to the commitment to personalized medicine in the biopharmaceutical and diagnostic industries as well as at FDA.” Report at page 14.
The PMC cautions that to ensure continued progress, policy makers must continue to favor policies that encourage advancement in the field. Report at page 14.
To further support and maintain momentum in the field, the PMC has co-organized a bicameral, bipartisan Congressional Personalized Medicine Caucus on February 26, 2020 in Washington, DC. The meeting will explore what personalized medicine is and why it matters, with an emphasis on the clinical and economic benefits of earlier disease detection and improved prevention strategies. Registration details here.