We are very pleased to see the Committee’s 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 would 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 the Committee’s analogy that “[t]he discovery, development, and delivery process is a cycle, meaning that data captured and analyzed on the delivery side informs new discoveries and better, more targeted solutions for patients.” On the upswing of that cycle, if being implemented in compliance with principles of patient-centeredness, is an informed and empowered patient being treated by providers with the 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.