We would urge the HELP Committee to explicitly focus on incorporating patient perspectives into the regulatory process and to help address their unmet medical needs as part of building the foundation for 21st Century medicine. We also urge the Committee to more explicitly recognize as a goal of its work the need to ensure health care decisions are made based on the principles of shared decision-making. This means arming patients and providers with the evidence and tools necessary to make informed decisions based on the needs, preferences, and circumstances of the individual patient. It also means establishing policies that incentivize providers and empower patients to make informed treatment decisions within new payment models.
We agree with Dr. von Eschenbach’s statement that, “In order to accelerate and enhance the efficiency of our nation’s healthcare ecosystem – discovery, development, and delivery – all three of these core components must be well- coordinated, consistently evaluated, and effectively nurtured.” To be patient-centered, each stage of innovation should be evaluated to determine its ability to inform and empower patients and their providers by enabling the use of tools to deliver personalized care. Our comments will therefore focus on the need to develop policies that ensure patient engagement and capture patient preferences to support the discovery, development, and delivery of innovative new medicines.
The full comment letter is available below.