PERSONALIZED MEDICINE AT FDA

The transformation of health care from one-size-fits-all, trial-and-error medicine to a targeted approach utilizing each patient’s molecular information continues to accelerate as the U.S. Food and Drug Administration more regularly and rapidly approves diagnostic tools and treatments that expand the frontiers of personalized medicine. Personalized medicine, sometimes called individualized or precision medicine, is a rapidly evolving field in which physicians use diagnostic tests to determine which medical treatments will work best for each patient or use medical interventions to alter molecular mechanisms, often genetic, that cause disease or influence a patient’s response to certain treatments. By combining molecular data with an individual’s medical history, circumstances and values, health care providers can develop targeted treatment and prevention plans. Following the approval of 11 new personalized medicines last year, personalized medicines now account for more than one of every four drugs the agency has approved in the past six years. This figure represents a sharp increase since 2005, when personalized medicines accounted for 5 percent of the new therapies approved each year. In 2019, the agency also expanded the indications for several existing personalized therapies; approved a new gene therapy for the treatment of a rare disease; and qualified the first digital technology platform via its pre-certification program. These new drugs and technologies will help physicians develop safer and more efficacious targeted treatment regimens.

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