FORBES | In a document issued this week, the Food & Drug Administration laid out for comment its draft guidance of how real-world evidence could support regulatory decision-making for medical devices. This is a positive step forward for improving the medical product development process. At the Bipartisan Policy Center, Representative Bart Gordon and I have been urging FDA to advance medical innovation with real-world evidence. FDA has limited this guidance to how real-world evidence may be used for regulatory review of medical devices. But the FDA is to be applauded for taking this step, and acknowledging the increasingly vital role real-world data (RWD) will have in healthcare.
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FORBES | Two weeks ago I led a panel discussion at the Bipartisan Policy Center (BPC) on medical innovation with my good friends Senator Lamar Alexander (R-TN), who chairs the Senate Health,Education, Labor and Pension (HELP) Committee, and former Congressman Bart Gordon (D-TN), who previously chaired the House Committee on Science and Technology. We were joined by Nashville native Doug Oliver, who had a powerful story to share.
Senator Lamar Alexander (R-TN), Doug Oliver, former Congressman Bart Gordon (D-TN), and myself.
Doug inherited a rare condition called dry macular degeneration. His vision began rapidly deteriorating at age 32, and within a year he was legally blind–unable to recognize faces, read the paper, continue his IT job, or drive a car. His doctor told him told him there was no cure but encouraged him to monitor clinicaltrials.gov, the federal site we set up when I was in the Senate where NIH-approved clinical trials are listed, for any new experimental studies that specialized in his illness. Doug was diligent and in time found a physician in Florida who was treating his condition with patients’ own stem cells.
Doug’s decision to participate in this clinical trial was life-changing. His own stem cells were isolated in a centrifuge from bone marrow drawn from his hip bone, and then injected into his retinas. Doug saw improvement overnight, and within months—after a decade of blindness—he passed the Tennessee driver’s test and got his license back.
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