The Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the organization will update its implementation plan, “Benefit-Risk Assessment in Drug Regulatory Decision-Making,” which details how patient experience data can better inform benefit-risk assessment. As part of this effort, the FDA will: begin hosting patient-focused drug development public meetings to gather patient perspectives on specific conditions and treatments; provide patients, caregivers and advocates with opportunities to give meaningful input into drug development and regulatory decision-making, and launch pilot programs to influence the design of clinical trials. This is a much needed shift in the value placed on patient perspective in the drug development and approval process as it may change patient experience entirely and place more emphasis on patient-centric advocacy groups. It’s a reminder that as healthcare marketers, we must continue to keep the patient voice top of mind.

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