Patient-Focused Drug Development: Methods to Identify What Is Important to Patients; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
The National Health Council (NHC) is pleased to provide comments on the Food and Drug Administration’s solicitation for comments Patient-Focused Drug Development: Methods to Identify What Is Important to Patients; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders (Draft Guidance 2).
Founded in 1920, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. The NHC provides a united voice for the more than 160 million people with chronic diseases and disabilities and their family caregivers. Made up of more than 140 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; representatives from the pharmaceutical, generic drug, health insurance, device, and biotechnology industries; and research, provider, and family caregiving organizations.
We appreciate FDA’s commitment to evolving the science of patient engagement through your series of guidances. We commend FDA for seeking to reach a broad swath of the healthcare stakeholder community – including the patient community, when developing this series. We understand the challenge that this presents in terms of the level of detail to provide. Below, we offer recommendations on how to strengthen Draft Guidance 2 and provide specific comments on the draft guidance’s sections.