By: Marc Boutin
The National Health Council and the entire patient community embrace the Food and Drug Administration’s forward-thinking efforts to engage patients early and often to make drug development truly patient-focused.
In 2015, the NHC and the Genetic Alliance hosted a multi-stakeholder dialogue, “Advancing Meaningful Patient Engagement in Research, Development, and Review of Drugs,” which was in response to stakeholders’ increasing demands that, in addition to demonstrating product safety and efficacy, new product sponsors engage patients and ensure that products enhance the outcomes patients care most about. Our dialogue identified critical barriers hindering advancement of patient-focused drug development, which fell into three major categories: culture, communication and the need for regulatory guardrails. Participants proposed actionable steps to overcome these barriers, including creating regulatory guidance. At the time, we suggested the patient community and regulators work collaboratively to set a path forward.
Read the entire piece from Morning Consult.