FDA’s Draft Guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input


The National Health Council (NHC) appreciates the opportunity to provide comments on the Food and Drug Administration’s (FDA’s) draft guidance on Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.

The NHC is the only organization that brings together all segments of the health community to provide a united voice for the more than 160 million people with chronic diseases and disabilities and their family caregivers. Made up of more than 100 national health-related organizations and businesses, the NHC’s core membership includes the nation’s leading patient advocacy organizations, which control its governance and policy-making process. Other members include professional and membership associations, nonprofit organizations with an interest in health, and representatives from the pharmaceutical, generic drug, health insurance, device, and biotechnology industries.

We applaud the FDA for its efforts and timely actions to encourage and guide meaningful patient engagement. The FDA’s first draft guidance on Patient-Focused Drug Development (PFDD) is an important milestone in this area. The NHC appreciates that this guidance (referred to hereafter as Guidance 1) is the first of a series of guidance documents the FDA will release to address the collection and submission of patient experience data. The NHC understands these guidances must evolve to accommodate new research, evidence, and learnings in the science of patient engagement. As such, the NHC is committed to working with the FDA to ensure this and future guidances support our shared goal to strengthen patient engagement in the research, development, and regulation of medicines.

Below, we offer recommendations on how to strengthen the draft guidance, provide specific comments on the draft guidance’s sections, and encourage more details on how engagement with the FDA will be operationalized.

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