FDA Needs Formal Mechanism To Integrate Patient Input, Groups Say
Although FDA says its drug reviewers are benefiting from the patient-focused drug development meetings under PDUFA V, stakeholders say a formal methodology is needed to incorporate patient input into the benefit-risk framework and drug review process.
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Industry mostly using the patient-reported outcomes as exploratory endpoints.
In response to stakeholder concern about multi-year schedule for patient-input guidance development, FDA says it only has a few experts and has to balance their time.
FDA’s clinical review teams are starting to approve novel drugs and biologics using a new structured benefit-risk framework developed under PDUFA V. Those assessments ask reviewers to think more broadly about the disease and how a new treatment might fit into the current treatment model. But many reviewers don’t have that information. And that, FDA says, is where patient advocates come in.